Differences in rural and urban patient perceptions of facilitative factors for cancer clinical trial participation

Abstract

Background

Rural populations are underrepresented within cancer clinical trials. Lower enrollment may exacerbate disparities in rural and urban health outcomes. Although research on the patient-related facilitators of clinical trial participation has been conducted, rural populations have limited representation within this research. The present study aims to understand the factors that influence clinical trial participation in rural compared to urban cancer patients.

Methods

We conducted semi-structured interviews with rural (n = 15) and urban (n = 15) cancer patients currently enrolled in an active treatment clinical trial. The participants were recruited from the University of Vermont Cancer Center and affiliated Central Vermont Medical Center. Rural was defined using the Rural-Urban Commuting Area Codes (rural ≥ 4). The interviews included closed- and open-ended questions. Closed-ended questions were analyzed quantitatively, and qualitative themes were extracted from open-ended questions.

Results

Although rural and urban patients rated the quantitatively measured factors similarly, differences were found within the qualitative themes. Personal transportation and a free, local lodging option were more essential for rural patients. Similarly, all patients benefited from well-coordinated appointments, but rural patients especially appreciated when cancer-related visits were coordinated with non-cancer ones. Rural patients also tended to prefer in-person contact with their healthcare team. Urban patients more often noted enrolling in trials to advance treatment for future patients or receive additional services themselves.

Conclusions

Our findings indicate that the structure and systems of clinical trials may improve care coordination experiences above and beyond treatment as usual. All patients benefit from care coordination, but it is especially important for rural patients who often experience fragmented care. Planning for coordinated appointments, travel logistics, and in-person communication may increase rural patient participation in clinical trials.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12913-025-13698-2.

Background

Patient participation in clinical trials is essential for advancing treatment and improving health outcomes. Widespread, representative trial enrollment ensures that clinical trials can be conducted quickly, facilitating the availability of efficacious new treatments to the wider patient population. Furthermore, principles of research dictate that trial access should be equitable and easy for all patients to ensure generalizability of results and reduce participant burden.

Though an estimated 70% of patients in the United States report willingness to participate in a clinical trial [1], only 2–3% of adult cancer patients enroll; this rate has not changed substantially over time [2]. Among those who enroll in clinical trials, rural patients are disproportionately underrepresented [3]. Underrepresentation may be due to limited trial or healthcare access, or financial barriers and physical burden related to traveling for treatment [4]. Physicians may also be more hesitant to recruit rural patients due to the anticipated burden of trial participation or believing rural patients to be generally less receptive to trials [5]. Lower clinical trial enrollment rates of rural cancer patients may exacerbate disparities in patient health outcomes, including mortality [6–8]; Indeed, when rural patients engage in clinical trials their outcomes tend to improve [4].

Research on the patient-related facilitators of clinical trial participation has been conducted to identify ways to improve recruitment (e.g., mistrust of research/researchers, loss of control, fear of side effects) [2, 5, 9]. However, here again, rural populations have limited representation within this research. In fact, most clinical trial research takes place in large urban cities or metropolitan areas [10]. The few enablers that have been identified for rural patients include attitude toward and knowledge of trials as well as reimbursement of travel related costs or willingness to travel [5]. The present study aims to further understand the factors that positively influence clinical trial participation in rural compared to urban cancer patients. Specifically, we sought to answer whether rural patients perceived different burdens or facilitative factors than urban patients when enrolling in clinical trials.

Methods

Study design

We collected quantitative and qualitative data during semi-structured interviews. Participants were asked discrete questions regarding the influence of predetermined factors related to clinical trial participation and were asked to elaborate on their responses during open-ended conversation. Separate quantitative and qualitative analyses were conducted. COREQ guidelines for reporting have been adhered to (see Supplemental Materials).

Selection and description of participants

Potentially eligible participants from the University of Vermont Medical Center and affiliated Central Vermont Medical Center were identified by the Clinical Trials Office. Patients were eligible if they (1) had a cancer diagnosis and (2) had signed consent forms and begun treatment in an active treatment clinical trial between January 2022 and May 2023. Thirty-nine eligible patients were contacted over the phone, and thirty patients agreed to participate in a semi-structured interview. About 2/3 of participants were enrolled on trials involving several weeks of radiation therapy, often in combination with chemotherapy. The remainder received chemotherapy-based treatments that required travel to the treatment center a minimum of every 2–3 weeks. As the original intent of the interviews was a quality improvement project, this study was reviewed by the University of Vermont Institutional Review Board and determined to be exempt.

Data collection and measurements

The first author (a PhD-level graduate student with three years of experience conducting semi-structured diagnostic interviews) conducted individual, semi-structured phone interviews lasting approximately 30 min. Verbal consent to participate and audio record the interview was provided at the start of the phone call, and demographic information was collected. The interview questions were developed a priori by the research team to understand the patients’ experiences during the clinical trial (e.g., travel time to the hospital, communication with hospital staff; see Supplemental Materials). Close-ended questions centered around 18 factors hypothesized to be relevant to rural patients’ clinical trial experience based on prior literature (e.g [11–13]), and pre-existing hospital services. Open-ended questions expanded upon the closed-ended questions and inquired about other components that eased patient experience. All interviews were recorded, transcribed verbatim, and anonymized prior to coding. Additionally, the interviewer entered close-ended question data directly into Qualtrics (a HIPAA compliant survey software) during the interviews. As the original intent of the interviews was quality improvement, transcripts were not provided to participants for comment and/or correction.

Statistics and analyses

Descriptive analyses were conducted on demographic data. Quantitative data were generated from close-ended interview questions. Patients were asked about their experience with 18 factors potentially relevant to clinical trial participation (see Table 2) and responses were coded as “helpful” or “not helpful.” Chi-square analyses were performed to compare the frequency of “helpful” ratings between urban and rural patients. All quantitative analyses were performed in SPSS 29.

Table 2.

Frequency with which the 18 a priori relevant factors were endorsed as “helpful”

Characteristics	Urban	Rural	p-value
Travel time	6	2	0.216
Transportation method	14	14	1.000
Local lodging (Hope Lodge)	1	4	0.327
Non-medical expenses	3	2	1.00
Access to alternative child care	0	0	N/A
Access to alternative adult care	0	0	N/A
Ability to take time off work	2	1	1.00
Access to vouchers / other resources	13	7	0.053
Financial support from the hospital	2	3	1.00
Insurance coverage	13	14	1.00
Treatment regimen	1	3	0.591
Side effects	0	0	N/A
Scheduling extra visits for the study	2	2	1.00
Coordination of visits for treatment and study purposes	9	8	1.00
Clinic hours of operation	13	12	1.00
Telehealth appointments	5	2	0.388
Access to an identified nurse navigator or care team point person	11	11	1.00
Communication style of hospital staff	14	15	1.00

Note: p-values are from chi-square tests comparing urban and rural patients across the 18 a priori factors

Qualitative analysis of the open-ended aspects of interviews was conducted using a directed content analysis [14]. After reviewing qualitative responses, all of the researchers independently read and coded two interviews to identify important themes described in the codebook, which was developed alongside the interview guide. Next, using the constant-comparison method, the team met to compare and refine the codes. A finalized codebook was generated. Transcripts were then randomly assigned and coded independently by the research team. Discussions were held to achieve consensus. Qualitative themes were compiled separately for rural and urban patients.

Results

Demographic characteristics of the participants are presented in Table 1. Overall, 15 (50%) participants lived in an urban location and 15 (50%) lived in a rural location. Rurality was determined based on household zip codes scoring four or more on the Rural Urban Commuting Area [15]. There was no statistically significant difference between rural and urban participants in age, gender, race/ethnicity, or retirement status. Participants were predominantly older (M = 71.91 years), White (100%), men (76.67%).

Table 1.

Demographic characteristics of interview participants

Characteristics	Urban	Rural
Age, years (Mean, SD)	72.87 (8.00)	71.00 (6.54)
Gender (n, %)
Female	4 (23.67%)	3 (20.00%)
Male	11 (73.33%)	12 (80.00%)
Race (n, %)
White, non-Hispanic	15 (100.00%)	15 (100.00%)
Work Status (n, %)
Retired	7 (46.67%)	9 (60.00%)
Working	8 (53.33%)	6 (40.00%)

Note. Only patients who were fully retired (not semi-retired or retired from their primary profession only) were counted toward the retirement category. Rurality was categorized based on household zip codes using 2010 Rural-Urban Commuting Area (RUCA) scores

Quantitative analysis

There were no significant differences between rural and urban patients in relative helpfulness of the 18 a priori factors (ps > 0.05; Table 2).

Qualitative themes

Three major themes were identified from the open-ended interview questions: enrollment motivation, travel and financial considerations, and communication and operations.

Enrollment motivation

Enrollment motivation included three subthemes: (1) trust in one’s medical provider, (2) altruism or advancing care for future patients, and (3) perceived additional benefits of trial treatment for one’s own recovery.

Both rural and urban patients appreciated hearing about clinical trials from their doctor, who they felt was knowledgeable and trustworthy. In fact, they often mentioned deferring to the doctor’s expertise regarding clinical trial enrollment.

I just followed the doctor’s advice because I felt very confident in the doctor and what they were doing. (Patient 1, urban)

Almost half of patients, a few more urban than rural, identified the altruistic element of clinical trials by improving care for future patients with a similar diagnosis. Often altruism was mentioned as an extra benefit of trial participation rather than the primary motivator (i.e., improving their own health outcomes). Additionally, two patients spoke of advancing the science, and one patient mentioned improving staff training.

I think trials are important to advancing treatment, and so my participation isn’t totally selfish. I do want to help advance the science in any way I can. (Patient 20, urban)

Approximately one third of patients, more urban than rural, perceived clinical trials as offering extra attention or additional follow-up once treatment ended, which motivated participation.

I was very happy to take part in the trial partly because it gave me this additional test for what type of cancer my cancer was, which was pretty expensive otherwise […] So, I did like the fact that being in a trial does get you a little additional attention. (Patient 4, rural)

A smaller number of patients reported receiving the most aggressive or advanced treatment as a benefit of clinical trials.

I thought that it was important that we do everything […] So the fact that it [the clinical trial] was sort of the newest thing and […] I was willing to be aggressive. As aggressive as possible. (Patient 9, urban)

Financial and travel considerations

Financial and travel considerations included three subthemes: (1) treatment cost, (2) nonmedical expenses, and (3) travel logistics.

Regardless of rurality, patients generally found insurance helpful to have during treatment; however, sometimes fees were higher than expected or insufficient information led to confusion about coverage (e.g., expecting all treatment costs to be covered by the trial). Additionally, a small percentage of patients reported needing to advocate with the hospital or insurance company to ensure maximum coverage of treatment costs. Even so, most patients had an uneventful billing and reimbursement process.

We didn’t even consider the insurance because we never paid anything extra on it. We were never concerned about the insurance. (Patient 5, urban)

The most common non-medical expense among rural and urban participants was gas. Parking and ferry vouchers were also mentioned as important to defraying nonmedical costs, and patients appreciated that these were proactively offered. Urban patients benefited the most from the parking vouchers due to hospital differences in parking costs.

That [parking vouchers] was handled very efficiently. We had a lot of fun doing that when I would come in and get stamped each day at radiation. It became a game with the office crew there. (Patient 6, urban)

Although all patients endorsed having their own transportation as helpful, a personal vehicle was described as essential for rural patients due to a lack of consistent and convenient public transportation. In fact, most rural participants, and a few urban participants, endorsed having no options besides driving themselves or asking a friend/relative to drive them to the hospital for treatment. Rural patients often justified their longer commutes (e.g., superior medical care) or were “used to” the drive.

We didn’t see it as a big burden because we like to go to [the city], and I mean you got to do what you got to do. And when it’s that important, you just do it. (Patient 4, rural)

Almost all patients, regardless of rurality, chose to return home following each appointment, finding the comforts of home a greater incentive than the detractions of the commute time.

I have friends who live in [the city] who offered me to stay overnight any time – it just felt so good to get home. We have a couple of dogs, and we live out in the boonies in the peace and quiet. I was quite happy to come home every day. (Patient 13, urban)

For the few rural families who required overnight stays closer to the hospital, the local American Cancer Society’s Hope Lodge was favorably mentioned as a service that assisted in their participation. No urban families utilized this service.

[At Hope Lodge] they cook food for the patients. And we ate really well while we were there. It was wonderful. […] For the most part I either drove over […] or I had a driver come from the hospital and pick me up and bring me to the hospital. It was a short ride. But, you know, there were some times I was just too weak to do that on my own. (Patient 3, rural)

Operations and communication

The operations and communication theme was subdivided into two subthemes: (1) coordination and ease of visits and (2) quality and frequency of communication with staff.

Two-thirds of patients reported that study-specific visits were well-coordinated with treatment visits. Rural participants were especially appreciative when staff coordinated clinical trial visits with non-cancer related appointments. For approximately half of the patients their trial experience was so “easy” they made no distinction between receiving standard treatment and participation in the clinical trial.

The fact that I was in a trial didn’t really change anything about my treatment. It was just a question of how long I would be doing this [drug name]. So, if I wasn’t in the trial, I would have done exactly the same thing other than the questionnaires I filled out. (Patient 24, rural)

Often an easy experience was attributed to strong communication with the care team, which included the clinical trial coordinator. Although many patients shared that they had very large treatment teams, patients—especially rural patients—appreciated having a point person or repeated contact with the same staff, especially for managing and coordinating appointments or understanding side effects.

I talked with the women who did all the planning a lot. Most questions I had she answered them for me. […] Because I was full of questions. I just wanted to be sure I understood exactly what I was going to be going through. (Patient 3, rural)

Similarly, all patients appreciated frequent meetings to get their questions answered by doctors, nurses, or clinical trial staff. They knew who to contact with questions outside of these meetings, although some, mostly urban participants, chose not to contact providers outside of their scheduled appointments. Patients emphasized the straightforward and supportive explanations they received from their providers.

I can ask him anything. He sits right down, and he talks to me like I’m his neighbor. We always just chitchat. And we get to the point and we stay on topic. And I understand everything he’s saying to me, and I really like that. (Patient 2, rural)

This high-quality communication helped patients know what to expect (e.g., randomization, treatment dosage, possible side effects) and accept certain negative aspects of treatment trials, such as scheduling.

I’d say [frequent appointments] was a real pain, but it was absolutely necessary, and I understood that from the beginning. I think the oncologist explained to us so well at the beginning what was involved […] So, I have to say it was very hard, but it was absolutely necessary, and it was explained to us, and I understood that. (Patient 13, urban)

Discussion

Prior research suggests that most cancer patients are interested in participating in clinical research, though very few actually enroll, and rural cancer patients are especially underrepresented [1–3]. Patients in our study endorsed presentation of the clinical trial by their doctor as the most important motivator for clinical trial enrollment. Doctors frequently serve as the gatekeeper to clinical trials and may or may not provide information on trials due to variety of personal factors (e.g., perceived level of burden for the patient) [16]. However, when eligible patients are offered trial participation, they agree more than 50% of the time [2], suggesting that gatekeeping may inadvertently decrease participation in clinical trials. Another identified motivator for clinical trial enrollment was helping others by improving treatment procedures. The act of helping others may help patients derive meaning from their cancer diagnosis, which in turn may serve to help manage distress and enhance quality of life [17]. Thus, setting aside perceived burden and systematically offering trial enrollment to both urban and rural patients could decrease under enrollment. Furthermore, highlighting the altruistic elements of clinical trials may be a useful strategy for recruitment.

Quantitatively, there were no differences in the 18 a priori factors expected to positively influence clinical trial experiences. This finding is in contrast to several differences that were apparent within the open-ended questions of the interview.

Cancer treatment can cause economic burden due to medical and non-medical related costs. Approximately half of individuals with cancer face this type of financial toxicity [18]. In contrast to the preexisting literature, all patients reported satisfaction with having insurance during their treatment process, and most endorsed low financial burden. This finding may be due to patient age and resultant Medicare coverage. Even so, some patients endorsed confusion about medical related costs. For example, what is covered by the trial and what is charged to insurance. Future trials should endeavor to ensure patient understanding about the financial costs for treatment. Differences in urban and rural patients’ experiences with non-medical costs were primarily due to differences in care contexts (e.g., the urban hospital charged parking fees). Moreover, rural patients may have been more reliant on their own transportation to appointments. Given the prolonged timeline of cancer treatment, reliable transportation may mean the difference between delaying or foregoing treatment and accessing it in a timely manner. Our data suggests the longer commutes for rural patients did not deter them from participating in clinical trials, but additional costs may have been accrued. Providers should ensure that rural patients are aware of resources for defraying non-medical costs from the outset. Alternatively, opportunities to engage in research could be provided at smaller clinics closer to rural patients’ residences.

Cancer care is often fragmented with patients receiving multimodal treatments across a variety of clinics [19]. Poorly coordinated care is linked with many adverse outcomes such as poor symptom control [20], higher health care costs [21, 22], and increased morbidity and mortality [19, 23]. Previous research suggests that rural patients perceive worse care coordination than urban patients, specifically communication and operational challenges [24]. However, experiences may differ for patients enrolled in clinical trials [24]. In the present study most patients indicated their care was well coordinated. Rural patients especially noted the helpfulness of coordinated appointments. Clinical trial coordinators may serve an important role in general care coordination, improving patient experience compared to standard care. In fact, the addition of a trial coordinator may explain the difference between the present results and previous research conducted with patients not enrolled in a clinical trial. Therefore, designating a specific coordinator who coordinates appointments across departments (cancer related and otherwise) may enhance rural patients’ care experience and minimize burden during clinical trials.

Both rural and urban patients shared appreciation for the quantity and quality of communication, including repeated contact with the same provider(s). Easy access and familiarity with healthcare providers may enhance patient understanding of clinical trial and treatment procedures, which may improve satisfaction with their care experience. In contrast to patients receiving standard care [24], the structured meeting schedule clinical trials often provide may enhance rural patients’ perceptions of care coordination via communication.

Overall, the satisfaction with the coordination of care is in line with previous quantitative research, which suggests that patients undergoing clinical trial treatment experience greater care coordination than patients receiving standard treatment [25]. Clinical trials may create structure and systems around care that counteract the usual difficulties with fragmented care and may be especially beneficial for rural patients. Given the benefits to rural patients, enrollment in clinical trials is likely to improve their care experience and their health outcomes.

Strengths, limitations, and future directions

Although collecting and analyzing both quantitative and qualitative data is a strength, our study has a few limitations. First, our sample was predominantly retired or semi-retired men, and all patients were White, non-Hispanic. This sampling bias was a result of the clinical trials recruiting during our enrollment period and the demographics of the geographic area. Additionally, due to the original intent of data collection (i.e., quality improvement) participants’ socioeconomic status and education level was unavailable. Patients from more affluent areas or who have access to more socioeconomic resources (e.g., a personal vehicle, social support) may be more likely to travel for care; patients with more limited resources may face different barriers and thus benefit from different interventions. Future research may wish to include information on these additional demographic factors to understand their role in patients’ clinical trial experience. Second, the sample size was also relatively small, potentially contributing to the lack of significant differences the rural and urban groups during quantitative analyses. Replication with a larger sample size would improve confidence in our findings. Third, our sample was comprised of individuals who had already enrolled in a clinical trial. Future research may benefit from identifying factors that participants perceived to be helpful before enrolling or that motivated their enrollment decision. Finally, although the 18 factors the researchers based the interview questions on were developed from the pre-existing literature and known hospital services, there may be other factors that were not addressed in this study. Additional research and interviews with rural patients understanding their clinical trial experience is warranted.

Conclusion

Enrollment of rural patients in clinic trials may be improved by using a trusted doctor to inform patients of trials and implementing systems and structures to improve their care coordination experiences. Our findings specifically highlight the importance of coordinated care for an optimal patient experience. Even rural patients, who often experience fragmented care, reported good care coordination due to participation in the trial. In fact, the structures and systems around clinical trials may enhance care coordination creating more equity for rural patients. Expanding clinical trials’ infrastructure to enhance these additional supports may (1) facilitate recruitment of rural patients into active clinical trials and (2) improve healthcare quality by reducing fragmentation of care. Improving recruitment ensures equitable rural patient representation in research and may improve health outcomes and treatment satisfaction through access to high quality care.

Supplementary Information

Below is the link to the electronic supplementary material.

Author contributions

RFH, MR, and MCL developed the interview questions. MCL conducted the interviews. MCL and JC transcribed the interviews. MCL conducted quantitative analyses, and all authors conducted the qualitative analyses. MCL was a major contributor in writing the manuscript. All authors read and approved the final manuscript.

Funding

Internal funds from the University of Vermont Cancer Center.

Data availability

The datasets used and/or analyzed during the current study, derived from surveys, are available in anonymized format from the corresponding author on reasonable request.

Declarations

Ethics approval and consent to participate

All patients had been enrolled on a clinical trial and completed written informed consent as approved by the University of Vermont Institutional Review Board for the individual trial. This follow-up study was implemented as a quality improvement project. It was reviewed by the University of Vermont Institutional Review Board and the IRB determined that additional informed consent was not required. The IRB reviewed the text of the information being provided to participants and deemed that agreement to answer the interview questions was patient assent and was sufficient.

Consent for publication

Not applicable. All quotes were anonymized.

Disclaimers

The views expressed in the submitted article are the authors’ own and not an official position of the University of Vermont Cancer Center.

Competing interests

The authors declare no competing interests.