Abstract
Objective:
This study explored patients and providers’ perspectives on therapeutic vaccines for cervical cancer and assessed barriers and facilitators.
Methods:
Qualitative semi-structured in-depth interviews were conducted with patients who had cervical dysplasia, or a past or current cervical cancer diagnosis and providers who provided care to patients with cervical abnormalities or cervical cancer. Data were analyzed using thematic analysis in NVivo.
Results:
A total of 28 in-depth interviews were conducted with patients (N = 15) and providers (N = 13). Participants in both groups expressed enthusiasm for the prospect of a therapeutic vaccine for cervical cancer and were encouraged by less invasive treatment opportunities. Perceived patient barriers included concerns about side effects, eligibility criteria, costs, transportation, and logistical obstacles. Providers echoed these concerns, highlighted additional structural barriers such as racism and limited availability of culturally sensitive educational aids, and underscored the need for provider training on this topic.
Conclusion:
Our results reinforce the need for future multi-level interventions discussing vaccine efficacy, durability, and safety, as well as addressing factors such as awareness, knowledge, and beliefs.
Practice implications:
Our findings can contribute to the development of provider and patient-centered tools that promote therapeutic vaccine acceptance.
Keywords: Cancer vaccines, Cervical cancer, Qualitative, Female, Humans, Adult, Neoplasms, Oncologists
1. Introduction
Cervical cancer has the potential to be the first Human Papillomavirus (HPV)-related cancer that can be eliminated (i.e., incidence rates < 4 per 100,000) with existing evidence-based prevention strategies like prophylactic vaccination, cervical cancer screening, and early treatment of pre-cancerous lesions [1]. However, elimination is likely to take an additional two to four decades [2]. A such, advances in cervical cancer treatment are critically needed [3]. Therapeutic vaccines hold promise as non-cytotoxic alternatives to traditional treatment options and several are currently under development and undergoing clinical trials [4]. Preliminary trial results show that therapeutic vaccines are safe and well tolerated, but none have been approved by the Food and Drug
Administration (FDA) [5,6]. As of April 2024, there are about 18 ongoing vaccine trials for treatment of precancerous lesions or cervical cancer recurrence; these trials are expected to be completed by 2028, with estimated accruals up to 2180 participants [7]. Prior qualitative research has found that patients are receptive to participating in novel vaccine or virotherapy trials [8], but little is known about patients’ and providers’ perceptions about therapeutic vaccines.
Understanding views and expectations toward novel treatments such as a therapeutic vaccine for cervical cancer can be an important first step toward understanding key factors that would aid in the development of interventions to promote vaccine acceptance. To our knowledge, no prior study has explored acceptance of therapeutic vaccines for cervical cancer. Therefore, we conducted qualitative in-depth interviews to explore patients’ and providers’ perspectives on therapeutic vaccines for cervical cancer and assess barriers and facilitators of vaccine acceptance. This research is important because it provides insight into how to promote vaccine acceptance before a therapeutic vaccine for cervical cancer becomes available to the general public.
2. Methods
2.1. Participant recruitment
Providers were recruited via professional network of the study principal investigator (PI). Potential participants were sent an e-mail from the PI describing the study and providing contact information for the study coordinator. Providers were eligible to participate if they: 1) spoke English and 2) provided care to patients with cervical abnormalities or cervical cancer (e.g., obstetric/gynecological providers or gynecologic oncologists). Patients were recruited using a variety of methods: 1) referrals from providers who had asked for permission to share the patient’s contact information with the study coordinator; 2) recruitment flyers posted in the cancer center’s Gynecologic Oncology clinic; 3) recruitment emails sent via a listserv Cervivor a patient advocacy and support group; 4) recruitment via ResearchMatch[9], an online research and engagement platform, and 5) community organizations. Patients were eligible if they: 1) were at least 18 years old; 2) spoke either English or Spanish; and 3) had cervical dysplasia, or a past or current cervical cancer diagnosis.
2.2. Data collection procedures
Interviewers trained in qualitative research methods conducted semi-structured interviews between June 2021 and December 2021. The study team developed a patient and provider interview guide assessing six core topics, including attitudes toward clinical trials and perceptions of a vaccine-based cervical cancer treatment (Tables 1 and 2). This manuscript reports on one topic: perceptions of a vaccine-based cervical cancer treatment. At the beginning of each interview, interviewers reviewed the consent form, answered study-related questions, and gave participants cursory information about vaccine-based cancer treatments (i.e., that they have been effective for other types of cancers and may be injected directly to the cancer site). Demographic information (e.g., age, race/ethnicity, gender) was collected from all participants (Table 3). All interviews were conducted over the phone, audio-recorded, and lasted an average of 47 min. Participants were compensated with a $50 electronic gift card.
Table 1.
Patient interview guide question regarding clinical trials and vaccine-based treatment.
| Domain | Questions |
|---|---|
| Knowledge/understanding of clinical trials | Have you heard of clinical trials? Tell me what you think of when you hear the term “clinical trials”. What is your understanding of a clinical trial for cancer? What is your understanding of how they work compared to other/traditional kinds of cancer treatments? |
| Participation in clinical trials | Have you ever participated in a clinical trial for a drug or treatment? (Was this for cervical abnormalities or cervical cancer care? Or something else?) Tell me about your experience. |
| Factors influencing decision making regarding participation in clinical trials | What are factors that would be important to you when making the decision about participating in a trial for cervical lesions or cervical cancer?
|
| Opinions on a therapeutic vaccine to treat cervical cancer | What do you think about a vaccine to treat cervical cancer? This vaccine would be injected directly into the tumor.
|
Table 2.
Provider interview guide questions regarding clinical trials and vaccine-based treatment.
| Domain | Questions |
|---|---|
| Availability of clinical trials, recruitment methods | Are there clinical trials available for patients at your practice? If so, for what types of medications or treatments? What phase of trials?
|
| Knowledge about therapeutic vaccines, perceived pros and cons | Novel treatments, like therapeutic vaccines or immunotherapy, have been effective in treating some cancers. One example is melanoma. These vaccines are intralesional. They are injected directly into the cancer site.
|
| Opinions about novel or experimental treatment approaches for cervical cancer | What would you think of cervical cancer patients trying novel or experimental treatment approaches (can be any novel or experimental treatments) for cervical cancer? Overall, how do you feel about novel or experimental approaches (like a vaccine-based approach) to treatment for cervical cancer? If they’ve heard of vaccine-based cancer treatment approaches ONLY:
|
| Types of patients more or less likely to participate in novel treatment approaches for cervical cancer/lesions/dysplasia | Do you think any groups of your patients would be more or less likely to participate in novel treatment approaches for [cervical cancer] or [cervical lesions or cervical dysplasia]? (e.g., low income, Spanish speaking or English as a second language, racial/ethnic minorities, hard to reach, have to travel further for care) |
Table 3.
Participant demographic characteristics.
| Frequency | % | |
|---|---|---|
| Patient characteristics (N = 15) | ||
| Age | ||
| 30–39 | 6 | 40 |
| 40–49 | 5 | 33 |
| 50–59 | 4 | 27 |
| Gender identity | ||
| Woman | 14 | 93 |
| Transgender man/non-binary | 1 | 7 |
| Race | ||
| Black/African American | 4 | 27 |
| Mixed race/Other | 1 | 7 |
| White/Caucasian | 8 | 53 |
| Ethnicity | ||
| Hispanic/Latinx | 4 | 27 |
| Non-Hispanic | 11 | 73 |
| Diagnosis | ||
| Cancer | 13 | 87 |
| Pre-cancer Cells | 2 | 13 |
| Provider characteristics (N = 13) | ||
| Age | ||
| 30–39 | 1 | 8 |
| 40–49 | 6 | 46 |
| 50–59 | 4 | 31 |
| 60–69 | 2 | 15 |
| Gender identity | ||
| Woman | 9 | 69 |
| Man | 4 | 31 |
| Race | ||
| Black/African American | 1 | 8 |
| Mixed race/Other | 3 | 23 |
| White/Caucasian | 9 | 69 |
| Ethnicity | ||
| Hispanic/Latinx | 0 | 0 |
| Non-Hispanic | 13 | 100 |
| Clinician specialty | ||
| Gynecologic Oncologist | 3 | 23 |
| Obstetrician/Gynecologist | 5 | 38 |
| Nurse Practitioner | 4 | 31 |
| Physician Assistant | 1 | 8 |
2.3. Data analysis
All interviews were transcribed. Two qualitative analysts (BA and AM) developed a preliminary codebook of a priori codes based on interview guides. Consistency was ensured by testing the codebook through independent and collaborative coding prior to line-by-line coding of interviews using NVivo 12 Plus software. Regular meetings with the study team were held during coding to monitor agreement and discuss preliminary findings. Discrepancies were resolved by consensus. Inductive codes were added to the codebook as they emerged, and each transcript was coded using the final codebook. Following coding, analysts synthesized the data into themes and subthemes using applied thematic analysis techniques[10]. Oversight was provided by a PhD-level Core Staff Scientist (CG) to ensure consistency. All study procedures were reviewed and approved by the [blinded] Scientific Review Committee and was granted exempt determination by the Institutional Review Board (IRB) of record, Advarra.
3. Results
3.1. Participant demographics
A total of 28 in-depth interviews were conducted with patients (N = 15) and providers (N = 13). Most patients were aged between 40 and 59 years (60 %), self-identified as women (93 %), White (53 %), non-Hispanic (73 %), and had a prior cervical cancer diagnosis (87 %). Most providers were White (69 %), non-Hispanic (100 %), self-identified as women (69 %), Obstetrician/Gynecologists (38 %), and between 40 and 69 years (92 %). See Table 3 for full demographic information. Findings are presented first by patients’ perspectives, followed by providers’ perspectives (Fig. 1).
Fig. 1.
Thematic map of qualitative data about views on therapeutic vaccines for cervical cancer.
3.2. Patients’ perceptions of therapeutic vaccines for cervical cancer
3.2.1. Patients’ positive views
Overall, patients expressed support for the idea of a novel, therapeutic cervical cancer vaccine. Some patients indicated that a therapeutic vaccine would be less invasive and potentially have fewer side effects than current cervical cancer treatments. Table 4 contains additional exemplary quotations.
Table 4.
Additional exemplary quotes by theme and participant group.
| Theme | Sub-theme | Exemplary quote |
|---|---|---|
| Patients’ perceptions | Positive views | “I would be all for [a therapeutic vaccine], yeah. If I can save somebody from what I’ve had to go through, it would be worth it, well worth it.” (Patient, White, 52 years). |
| Familiarity with other vaccines | “I don’t know a whole lot, I mean, outside of what you just told me. But the concept on its face sounds good and way smarter and way more progressive than the current treatment.” (Patient, Black, 33 years). | |
| Need for more information | “Traditionally, the way vaccines work is through antibodies. I don’t know how – I don’t know enough about the science of a potential vaccine to be injected into a tumor and how that would work based on what I know of how vaccines work. […] So, I guess my answer, I don’t know because I don’t understand the science of how the cells work and how a vaccine would work with that.” (Patient, White, 47 years) | |
| Patients’ perceived barriers | Lack of knowledge | “Right now, I mean, again, it depends on what do we know about it. What’s in this vaccine? How is it going to treat it? Are there any adverse effect that’s going to impact any of the surrounding organs? Is it going to impact my quality of life? So, it’s hard for me, again, because I don’t know much about it. Just like with any other vaccine, I would want to know how is it going to be beneficial for me. What are the downsides of it and what are the statistics behind it?” (Patient, Black, 40 years) |
| Financial and logistic burdens | “I think probably the big one would be cost, because I would imagine if it’s a new deal that maybe the insurance companies wouldn’t wanna do it somehow. I don’t know. I mean, I have great insurance, but I think that might be maybe a barrier.” (Patient, White, 49 years) | |
| Eligibility criteria | “I think for me it would be, again, what would disqualify me? Would the fact of what treatments I’ve had disqualify me?” (Patient, White, 52) | |
| Patients’ facilitators | New treatment options | “…The current treatment options are pretty terrible. You just literally get your cervix cut off every single time they think you have a growth, and there’s nothing else you can do about it. And, you only have so much cervix. So, to hear that there may be a shot that can go directly to the site and possibly reverse the whole thing, that is really positive news.” (Patient, Black, 33 years) |
| Fewer adverse effects | “If that was the case and they could treat somebody that was diagnosed with cervical cancer and not have to go through the hell that just I went through. Oh, that’d be awesome.” (Patient, White, 52 years) | |
| Avoiding invasive and permanent procedures | “An injection directly into a tumor and then hope that it disappears compared to radiation and the damage that that could cost the surrounding tissue. And the chemo, the damage that causes to your body. Or possibly the organ removal. Because, I don’t know, if this comes back you’re just gonna have to remove more […] But imagining that they’re gonna have to take my parts off and more of a recovery from that. It seems to me like a magic trick if there would be a vaccine for that.” (Patient, White, 39 years) | |
| Hope for a cure | “Because I think my initial reaction is, I guess the first – the Gardasil vaccine – is to prevent it from happening. But then there’s the people in my age group that missed the boat on that. And so, if now we have a second chance at it, if it were to work, you just inject it directly into the tumor – into the cancer cells – and it irradicates it, that would be awesome.” (Patient, White, 39 years) | |
| Providers’ Perceptions | Willingness to learn more about the vaccine | “I would probably want to know what research has been done so far. Where are they at in the process? Probably how invasive it could be compared to other treatments that are available. Side effects that could come along with it.” (Patient, White, 34 years). |
| Positive views | “Well, I think the more options we have, the better, particularly non-invasive options or medical therapy, as opposed to surgery, is always very attractive to patients, particularly in underdeveloped countries. They may not have as much resources.” (Provider, White, 52 years) | |
| Providers’ perceived barriers | Concerns about side effects | “… patients are predominantly interested in what do we know about efficacy if any and what is the side effect profile.” (Provider, Black, 47 years) |
| “You always worry about reactions.” (Provider, White, 49 years) | ||
| Patient’s burden | “Otherwise, distance from where they live from the hospital, and how many times they have to come in. If it’s a treatment that they just have to get one treatment every three weeks, patients are traveling three hours and they’re okay. If it’s every week, even a 30- minute drive can be an issue.” (Provider, Asian, 42 years) | |
| Patient’s mistrust | “Fear of the nontraditional. […] But yeah, I would think fear of is this experimental? And what does experimental mean? And I want the traditional thing that we know that works, so a fear of the new and a lack of cultural specificity in presenting the vaccine.” (Provider, Asian, 46 years) | |
| Organizational barriers | “The side effects, it all depends on the side effects and the level of care that would be necessary to monitor patients on these trials and if there are significant adverse effects that could occur and how they would be managed. Training of the staff to address some of these adverse effects.” (Provider, Black, 47 years) | |
| “If the education regarding the vaccine not being culturally specific, so if everything’s in English and Spanish, and you have the Brazilian Portuguese-speaking patient, and you’re using a family member to translate to them or doing everything through a translator which is perfect, but sometimes it’s great to at least have the reading material that they can go home with in their language.” (Provider, Asian, 46 years) | ||
| Vaccine politicization | “It’ll be interesting if you can talk people into it as those will work I think is where it’s going to come down to, because especially with all fluff about the coronavirus and the vaccines for it and whether they’re working with the side effects. People have side effects worse and some of that brouhaha that’s going on out there. It might be a tougher sell now than it would have been a year ago, frankly, two years ago.” (Provider, White, 67 years) | |
| Patients’ informational needs | “It’s lack of understanding, and the previous myths that they don’t want to – similarly, people don’t wanna have vaccine for COVID-19. Lack of information, I think. Lack of knowledge about the vaccine.” (Provider, Asian, 42 years) | |
| Providers’ facilitators | Impact on patients’ quality of life after treatment | “Given that the current therapies for cervical cancer are very brutal and don’t work that well, I think it sounds good. There’s a lot of room to improve in this particular cancer. We’re good at prevention, but we’re – the treatment that they’re gonna die. So, I think we have room to improve that.” (Provider, White, 47 years) |
| Expanding treatment options | “So, for some things, like metastatic cervix cancer, it’s actually a little easier because there is not a lot of good effective therapies past the initial treatment for this disease. So, response rates are rather poor and response durations are rather poor. So, after their initial treatment, it’s pretty much time to get on a clinical study. And we’ve been seeing some better response rates on the patients in the clinical study than we have with standard treatments.” (Provider, White, 52 years) | |
| Patients’ familiarity with other vaccines | “I think because people understand vaccines. I think they grew up and they received vaccines, etc., COVID notwithstanding. […] I think because they understand what getting a shot for a vaccine is, so it’s not new and foreign to them, and I can assume it’s pretty easy to explain, unlike some of the drugs that we’ve – so I think all those things make it palatable. Plus, immune, if you just hear the word immune, people, and then, they love it. It does, and it has a buzz out there. And I think there is a lot of internet blogging that they go on and stuff like that that they read about this immune therapy worked for melanoma and someone doesn’t have cancer for 10 years. Those things get other people excited, too.” (Provider, White, 52 years) | |
| Hope for a cure | “…I think if they hear that this is something that could potentially cure them of this they’re much more open to trying something like that.” (Provider, White, 36 years) |
“Honestly, I think that would be good. Just like they have the HPV vaccines and things like that, if they had a vaccine to [treat] cervical cancer, that would be amazing.” (Patient, Hispanic, 37 years).” (Patient, Black, 40 years)
3.2.2. Familiarity with other vaccines
Patients indicated being familiar with vaccines as tools for disease prevention, expressed that therapeutic vaccines would be innovative forms of treatments, and showed receptiveness to the prospect of a therapeutic vaccine for cervical cancer.
“I feel like vaccines are something that, whether or not they’re experimental, they’ve still been in the making for a very long time. You know, it’s not something that happened overnight…” (Patient, Mixed race, 48 years)
3.2.3. Need for more information
Although patients indicated being aware of vaccines and supportive of a therapeutic vaccine, some patients said that they would need more information about the therapeutic vaccine to form an opinion about it.
“Traditionally, the way vaccines work is through antibodies. I don’t know how – I don’t know enough about the science of a potential vaccine to be injected into a tumor and how that would work based on what I know of how vaccines work. […] So, I guess my answer, I don’t know because I don’t understand the science of how the cells work and how a vaccine would work with that.” (Patient, White, 47 years)
3.2.4. Patients’ perceived facilitators
3.2.4.1. New treatment options.
Patients expressed enthusiasm for the possibility of new cervical cancer treatment options. Most patients saw the therapeutic vaccine as an opportunity to exercise more agency over how their body is treated.
“We need more treatment. We need more vaccines. We need something for women for endocervical adenocarcinoma. There’s no research out there. There’s none, hardly. They just give everybody the same, squamous cell or adenocarcinoma [treatment].” (Patient, mixed race, 48 years)
3.2.4.2. Fewer adverse effects.
When discussing about receptivity of a therapeutic vaccine, many patients shared having endured adverse effects and experiencing long-term side effects related to cancer treatment. Thus, a facilitator to receiving a therapeutic vaccine would be having new cervical cancer treatment options that would prevent them or other patients from enduring physical and psychological pain associated with side effects of treatment.
“… this injection could just target directly just the dysplasia and leave everything else intact, that seems like it would have a better outcome for future fertility. It seems like it would have minimal recovery. So, minimal impact on my life, less risk of infection.” (Patient, White, 34 years)
Avoiding invasive and/or permanent procedures. Another facilitator mentioned by participants was receiving a therapeutic option that would not modify the patients’ anatomy. During the interviews many patients shared having lost body parts, the negative implications of those invasive procedures, and how this might be a threat to their female identity.
“I’m just not that willing and eager to — one, in regard to hysterectomy — have the parts removed without giving it a lot of thought and care. I believe that there are other ways to deal with cancer besides what they do. […] Like I said, the community as a whole seems to feel like if women are beyond childbearing years — and even if they’re not sometimes — that the cervix, the uterus, the vagina — all those are optional parts. And I don’t agree with that. I think women should be able to remain as whole as they can.” (Patient, White, 58 years)
3.2.4.3. Hope for a cure.
Some patients commented how the vaccine might eliminate localized cancer and prevent it from metastasis and seemed intrigued about the curative scope of a therapeutic vaccine.
“Because I feel like when it metastasizes, it shrinks and moves throughout your body until it feels that it’s safe to grow. I don’t feel like you’re cleared from cancer, it just shrinks to where you can’t see it. So, if you’re injecting something to the site and you’re killing it on site, you don’t give it time to move into your bloodstream. I would go for that. I wouldn’t have a problem doing that.” (Patient, Black, 45 years)
3.2.4.4. Willingness to learn more about the vaccine.
Patients voiced their need for more education about therapeutic vaccines that could facilitate informed decisions related to cervical cancer treatment options.
“I would just have more information to make a better decision based off what I think is best for me. But it’s something that I would definitely be open to researching and asking questions about. I would want to speak to patients or hear patient’s perspectives who have done it.” (Patient, Black, 33 years)
3.2.4.5. Willingness to receive a therapeutic vaccine
When asked whether they would be willing to try a therapeutic vaccine for cervical cancer, most patients indicated yes (n = 11; 73 %), one indicated no (7 %), and three indicated that they would like to learn more about it (20 %).
3.2.5. Patients’ perceived barriers
3.2.5.1. Lack of knowledge.
Overall, patients expressed having a limited understanding of this type of vaccines. They indicated needing more information about how a therapeutic vaccine works, its purpose, administration process, immediate and long-term side effects, recovery process, and vaccine effectiveness.
“…What’s in this vaccine? How is it going to treat it? Are there any adverse effect that’s going to impact any of the surrounding organs? Is it going to impact my quality of life? So, it’s hard for me, again, because I don’t know much about it. Just like with any other vaccine, I would want to know how is it going to be beneficial for me. What are the downsides of it and what are the statistics behind it?” (Patient, Black, 40 years)
3.2.5.2. Financial and logistic burdens.
Patients indicated that having to attend to several follow-up visits, traveling long distances, having to miss work to recover, and vaccine cost or accessibility of the vaccine through insurance would be barriers to obtaining a therapeutic vaccine.
“And, as long as it’s not a ton of different follow-ups and that kind of thing and different parts to the procedure, not like you have to go back and get the vaccine three more times before it works or something like that, if it’s a fairly quick and simple fix, like an actual fix, that would be more attractive.” (Patient, Black, 33 years)
3.2.5.3. Eligibility criteria.
Another barrier mentioned by patients was concerns about their eligibility to receive a therapeutic vaccine because of their prior cancer diagnoses, comorbid medical conditions, or medications.
“I mean unless previous treatments that I’ve had are barriers to being able to get this vaccine or unless it prevents future treatments if it doesn’t work. I think those would be the main barriers to me.” (Patient, Black, 33)
3.2.5.4. Mistrust.
Mistrust in the healthcare system and structural racism were mentioned as obstacles to individuals of diverse racial/ethnic backgrounds. One participant expressed her concern about new treatments not being are available for all people, and she hoped therapeutic vaccine trials include individuals from Black and Hispanic communities.
“I know that within the Black community, there are a lot of disparities, and there are some unfair treatment that is done, especially now with the vaccines. So people aren’t getting vaccinated and they’re not treated fairly because of it… Is this something that would be fairly distributed, if it’s something that works, among the Black community and Latino community? Because, I know that those are two demographics that have seen unfair healthcare practices. And, what are we doing to help bridge that gap within our healthcare system? And so, that’s what I would want to know more about as far as this vaccine.” (Patient, Black, 40 years).
3.3. Providers’ perceptions of therapeutic vaccines for cervical cancer
3.3.1. Positive views
Providers expressed enthusiasm regarding therapeutic vaccines for cervical cancer. Many of them indicated that they had heard of therapeutic vaccines for other types of cancer, such as melanoma, and that having an effective therapeutic vaccine can revolutionize cervical cancer treatment.
“I think it could be a great step in treating cervical cancer, and I think that moving away from the cytotoxic into things that may have a better toxicity profile and again are possibly individualized to the patient, I think it’s great.” (Provider, Asian, 46 years)
3.3.2. Concerns about effectiveness
One provider expressed concerns about vaccine effectiveness after reading about minimal success of therapeutic vaccines trials and their understanding of how vaccines work.
“Yeah. So, I have not had a lot of enthusiasm for that, even though we’ve opened up vaccine trials. I think the problem with vaccine trials is that you have to have an epitope or a marker for antigenic response, which is unique to that cell and has been causing surveillance that’s not gonna be lost over time. So, I just think that’s difficult to do with the cancers we have. Now, cervix may be an exception to that, just because of the HPV, but people have tried some HPV vaccines like that, and it just hasn’t panned out yet.” (Provider, White, 52 years), so if everything’s in English and Spanish, and you have the Brazilian Portuguese speaking patient, and you’re using a family member to translate to them or doing everything through a translator which is perfect, but sometimes it’s great to at least have the reading material that they can go home with in their language.” (Provider, Asian, 46 years)
3.3.3. Providers’ perceived facilitators
3.3.3.1. Impact on patients’ quality of life after treatment.
Providers recognized the impact of standard of care treatments on patients’ quality of life and said that a therapeutic vaccine might be less toxic and possibly not cause common debilitating side effects of chemotherapy or radiation.
“All of the things that we try to – we’re killing cancer, but we’re also in a way we’re harming the patient in ways. So, being able to individualize cancer care with things that are targeted and likely less toxic would make it something that people would be able to tolerate better, and if the treatment is more efficacious would be able to cure things in a way that overall survival and progression through survival is higher. […] It’s easier for the person, and you’re not harming the normal cells of the person. So, it’ll allow hopefully the patient to tolerate things better and increase the ability to allow the patient to live longer.” (Provider, Asian, 46)
3.3.3.2. Expanding treatment options.
Some providers said that expanding current treatment options for cervical cancer would be beneficial for patients and could provide them with additional choices.
“I think there’s trials out there where people are doing things like that and cervical cancer’s a hard cancer because it most affects younger women, like what we’ve talked about before and there’s not as many treatment options for cervical cancer as there are for some of the other cancers, so it’s a scarier cancer to begin with.” (Provider, White, 36 years)
3.3.3.3. Familiarity with other vaccines.
Providers mentioned that patients are familiar with other vaccines, and this might help with promotion efforts.
“I think many people can relate to vaccines, and they feel comfortable because they’ve had other vaccines as opposed to some very new method of treating. Even the word radiation is more scary than having a vaccine, which most people feel is quite benign.” (Provider, Asian, 42 years)
3.3.3.4. Hope for a cure.
One provider said that hope for a cure for cancer would be a facilitator for therapeutic vaccines, particularly if the vaccine if effective and can prolong patients’ lives.
“Some of the trials out there are used to control disease and then some of the trials out there are used to cure disease. So, I think if the patients hear that this is a trial that can potentially cure them as opposed to control them, I think that seems more appealing to them.” (Provider, White, 36 years)
3.3.3.5. Providers’ perception of their patients’ willingness to receive therapeutic vaccines.
When asked whether they thought their patients would be willing to undergo treatment with a therapeutic vaccine, most providers (n = 8; 73 %) indicated yes, none indicated no, and three (27 %) indicated they thought their patients would want to learn more.
3.3.4. Providers’ perceived barriers
3.3.4.1. Concerns about side effects.
Providers indicated that patients often express concerns about potential reactions and side effects. Some providers also indicated that they might have these concerns for their patients.
“… patients are predominantly interested in what do we know about efficacy if any and what is the side effect profile.” (Provider, Black, 47 years)
“You always worry about reactions.” (Provider, White, 49 years)
3.3.4.2. Patient burden.
Other providers recognized that patients have many logistic barriers associated with current treatments (such as time, distance, costs, number of appointments, etc.), and hoped that patients would not have to face similar barriers with a therapeutic vaccine.
“… it might be easier to actually have a vaccine if it’s something that is quicker and easier to get, doesn’t require the same monitoring and maybe a lesser amount of laboratory follow up, et cetera. If it ends up that it becomes a faster, more efficient, effective thing eventually, then yeah, [a vaccine] would be in the end easier for patients that have certain barriers, whether it be transportation, or support, or financial. It would be easier in that way.” (Provider, Asian, 46)
3.3.4.3. Patients’ mistrust.
Some providers mentioned mistrust in healthcare and research as a barrier. Providers expressed awareness of lack of trust that racial/ethnically diverse patients may have regarding medical research.
“I think that there definitely is a higher level of medical mistrust in communities that have been historically abused, like African American and Haitian.” (Provider, White, 47 years)
3.3.4.4. Organizational-level obstacles.
Providers mentioned a few organizational-level barriers such as limited staff training on how to monitor adverse effects of a therapeutic vaccine.
“The side effects, it all depends on the side effects and the level of care that would be necessary to monitor patients on these trials and if there are significant adverse effects that could occur and how they would be managed. Training of the staff to address some of these adverse effects.” (Provider, Black, 47 years)
3.3.4.5. Politicization of vaccines.
Some providers mentioned that diffusion of misinformation regarding vaccines against COVID-19 created misunderstandings and fears among the public and this may still affect the public’s hesitancy and distrust regarding new vaccines.
“Yeah, that has, especially with this COVID pandemic that we’ve had. It’s really hard to talk to some people about getting vaccinations and they’re just completely against vaccines. […] People really do not have the education to understand how safe that it would be. And, what’s frustrating with that is that they don’t want to learn.” (Provider, White, 54 years)
3.3.4.6. Patients’ informational needs.
Many providers indicated that patients have limited knowledge and awareness of therapeutic vaccines and that there is a need for culturally and linguistically targeted vaccine information.
“If the education regarding the vaccine not being culturally specific, so if everything’s in English and Spanish, and you have the Brazilian Portuguese speaking patient, and you’re using a family member to translate to them or doing everything through a translator which is perfect, but sometimes it’s great to at least have the reading material that they can go home with in their language.” (Provider, Asian, 46 years)
4. Discussion, conclusions, and implications
4.1. Discussion
Findings suggest that participants were open to a therapeutic vaccine for cervical cancer and encouraged by opportunities for non-cytotoxic treatments and autonomy with their care. Although a therapeutic vaccine for cervical cancer has not yet received FDA approval and is not available to patients, our findings provide insights about barriers and facilitators that can help develop future intervention strategies promoting therapeutic vaccine acceptance. Participants highlighted that the biggest facilitators to acceptance of therapeutic vaccines for cervical cancer were the opportunity for patients’ autonomy over their treatment options, their care, and their bodies. Patients highlighted the paucity of treatment options for cervical cancer and the need for less invasive, nonchemo toxic treatments – which is consistent with findings regarding therapeutic vaccine trials for ovarian cancer [8]. Both providers and patients lamented the harsh side effects associated with chemotherapy and radiation and were intrigued by alternative options. Patients discussed the immediate negative impacts of undergoing cytotoxic treatments to their pelvic region, mentioning that it was emotionally and physically invasive. Participants hoped that future cervical cancer patients would have more treatment options, consistent with calls for expanded treatment options[11].
Common barriers mentioned by patients were limited awareness and understanding about therapeutic vaccines for cervical cancer. Although patients indicated being familiar with other types of prophylactic vaccines, they expressed concerns about side effects, eligibility criteria, costs, transportation, and logistical barriers – which is consistent with studies exploring vaccine trial participation [8,12]. A novel finding was that participants expressed interest in learning more information about how therapeutic vaccines work against cervical cancer, how they compare to traditional cervical cancer treatments (e.g., surgery, chemotherapy, and radiation), and how they might offer a tailored approach to patients’ care. Participants’ openness to learning more about therapeutic vaccines for cervical cancer provides an opportunity not only to enhance their knowledge and awareness, but also to dispel any therapeutic misconceptions [13] such as beliefs about minimal recovery and lower risk of infection, or hopes that the therapeutic vaccine could also prevent cancer. Barriers reported by providers echoed those reported by patients (e.g., side effects, mistrust, logistical barriers) and further highlighted organizational barriers (e.g., structural racism, limited cultural sensitivity) and politicization of vaccines in the media.
This study has several strengths. First, we interviewed both patients and providers about their perceptions of therapeutic vaccines for cervical cancer, which closely resembled one another strengthening the validity of our findings. We used a diversity of recruitment methods to reach patients locally and non-locally with both current and past cervical cancer related diagnoses. To our knowledge, this is the first qualitative study to explore perspectives on a therapeutic vaccine for cervical cancer. However, findings should be considered in light of some limitations. We aimed to interview patients with both pre-cancerous cervical abnormalities and cervical cancers; however, we were only able to recruit two patients with pre-cancerous lesions. Thus, diversity of diagnosis was limited. The information gleaned from this research is also limited to cervical cancer/pre-cancer, limiting generalizability to other diseases or types of cancer. Small sample size, lack of information on educational background and insurance status of participants and recruiting providers only from the PI’s network of professional contacts are additional limitations of this study. The interviews were conducted based on a broad description of therapeutic vaccines for cervical cancer to explore initial perceptions toward the prospect of a therapeutic vaccine (Tables 1 and 2). Although our sample included the perspective of some individuals of diverse backgrounds, more research is needed on this topic – particularly including perceptions of underserved and underrepresented populations in clinical trial research.
4.2. Conclusions
Therapeutic vaccines hold tremendous promise for reducing cervical cancer related morbidity and mortality. However, without provider and patient acceptance, the potential benefits will not be fully realized. This study provides important reminders that key aspects of development must consider key areas such as cost, patient and provider burden, historical context of newly available treatments in diverse communities, and the impact of COVID-19 on the public’s perceptions (positive and negative) of “new” vaccines. Considering these factors throughout the cycle of vaccine development, trial, and dissemination stages will facilitate optimal benefit of new advances in cervical cancer treatment.
4.3. Implications
Our results reinforce the need for future patient-centered interventions that include assurances of vaccine efficacy, durability, and safety, as well as address factors that might influence vaccine acceptance such as awareness, knowledge, and beliefs. Future research should design tools and decision aids that are responsive to patient needs and describe the purpose and value of different treatment strategies, address potential therapeutic misconceptions, and include culturally sensitive information. Additionally, our findings could contribute to the development of provider-targeted trainings focused on improving knowledge and communication skills and addressing multi-level barriers to vaccine acceptance.
Funding
The work was supported with funding from a Moffitt Center for Immunization and Infection Research in Cancer Award (PI: Vadaparampil). This work has been supported in part by the Participant Research, Interventions, and Measurement Core Facility at the H. Lee Moffitt Cancer Center & Research Institute, an NCI designated Comprehensive Cancer Center (P30-CA076292).
Footnotes
CRediT authorship contribution statement
Lindsay Fuzzell: Writing – review & editing, Writing – original draft, Investigation. Ashley Whitmer: Writing – review & editing, Writing – original draft. Susan Vadaparampil: Funding acquisition, Conceptualization. Anna Giuliano: Funding acquisition, Conceptualization. Carley Geiss: Methodology, Formal analysis, Data curation. Arianna Mason: Methodology, Formal analysis, Data curation. Brandy Arredondo: Methodology, Formal analysis, Data curation. Julie Rathwell: Methodology, Formal analysis, Data curation. Mariana Arevalo: Writing – review & editing. Sylea Lowery: Writing – original draft.
Declaration of Competing Interest
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Anna Giuliano reports a relationship with Merck & Co Inc that includes: board membership and consulting or advisory. Dr. Giuliano’s institution has received funds to support HPV-related research. No other authors have conflicts of interest to report related to this paper. All authors attest that they meet the ICMJE criteria for authorship.
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