Abstract
Objective:
To evaluate the feasibility, acceptability, and preliminary efficacy of Families Addressing Cancer Together (FACT), a web-based, individually tailored, psychoeducational intervention for parents with cancer to improve illness-related communication with their minor children.
Methods:
Parents with stage I-IV solid tumors who had children ages 3–17 were randomized to 6 weeks of FACT vs. waitlist control. Feasibility was assessed by rates of recruitment and retention. Acceptability (primary outcome) was defined a priori as ≥75% of FACT participants rating FACT ≥12 (on an 18-point study-specific scale), and semi-structed interviews provided additional qualitative acceptability information. Generalized estimating equation methods were used to assess preliminary efficacy for communication self-efficacy, depression, and anxiety; Fisher’s Exact tests explored differences in individual communication beliefs and behaviors.
Results:
Forty-eight approached patients enrolled (recruitment rate: 73%), 85% were retained through the post-intervention assessment, and 78% rated FACT as acceptable. In the FACT group compared to control, the modeled improvement in CSES scores from baseline to post-intervention was 9.5 vs 0 points (p=0.004). FACT participants were more likely to have told their children that they have cancer (83.3% vs. 52.2%, p=0.03) and felt more prepared to answer their children’s questions about cancer (p=0.02). Groups did not differ in depression or anxiety.
Conclusions:
FACT was feasible, acceptable, and demonstrated potential to improve parents’ communication self-efficacy, beliefs, and behaviors. A large scale randomized controlled trial of FACT is needed to confirm these benefits and evaluate longer term effects on psychological outcomes for parents with cancer and their children.
Keywords: Cancer, Cancer Communication, Oncology, Parents, Parenting concerns
Background
Nearly one-fifth of US cancer patients are parents of at least one minor child,1 and globally cancer rates in adults under the age of 50 continue to rise.2 Parents with cancer worry how their illness will impact their children and family’s dynamics3,4 and often seek guidance on how to discuss their diagnosis, treatment, and prognosis.5,6 A parent’s ability to communicate their health status effectively and with developmentally-appropriate language is instrumental in promoting their children’s coping and adjustment.7,8
Unfortunately, publicly available resources for parents with cancer lack sufficient detail and specificity to empower parents to have illness-related conversations with their children and, as a result, clinicians are unsure about which resources to recommend.9,10 Research interventions designed to facilitate parent-child communication and enhance family adjustment in the cancer context have demonstrated encouraging results for parent mental health and parenting skills, but improvements in improving parents’ self-efficacy have been less consistent.11,12 Notably, these resource-intensive programs rely on highly trained professionals to deliver the intervention.12–14 This is problematic because even after providing medical professionals with additional parent support training education, time constraints and several other barriers have interfered with successful implementation.15 Further, most adults receive cancer treatment in community settings,16 which rarely have the personnel and resources to support parent-child communication. Finally, this delivery format is not practical for parents with cancer, who already balance multiple medical appointments, parenting demands, and occupational responsibilities. Web-based interventions may not only circumvent these practical challenges, but are also preferred by parents seeking parent-child communication support and are more readily tailored to individual patient circumstances.17–19
Regarding the importance of tailored communication interventions, prior interventions have failed to flexibly ‘move’ with the patient through their cancer trajectory (e.g., disease progression, treatment complications, functional decline), despite various junctures in cancer care presenting new communication challenges and intense emotions.20 Similarly, parents desire communication support that is developmentally appropriate,21,22,23 but no prior intervention has provided age-specific guidance for minor children and, related to this, prior trials have been limited to children within a narrow age range.24,25 Thus, there is a pressing need for a widely accessible, low-cost intervention that offers communication guidance to support parents in conversations about their cancer tailored to their health status and specific family needs.
To address this important gap in supportive cancer care, Families Addressing Cancer Together (FACT) is a theory-based, psychoeducational intervention for parents with cancer to improve communication about their illness with their minor children. FACT provides parents with individually tailored recommendations and guidance, including specific language to utilize during illness-related conversations, unique to information they provide about their specific health status and family dynamics. It was designed to be used with patients with any type of cancer at any point along their illness trajectory. We have previously shown in a single-arm trial that FACT, delivered face-to-face, is feasible, acceptable, and improves parents’ confidence and willingness to have illness-related conversations.23 The objective of this pilot randomized controlled trial (RCT) was to assess the feasibility, acceptability, and preliminary efficacy of a web-based version of FACT. We hypothesized that FACT would: 1) be feasible, as evaluated by % of approached eligible patients who enrolled (recruitment rate) and % of randomized participants who completed post-intervention assessments at 6 weeks (recruitment rate); 2) be acceptable to ≥75% FACT participants; and 3) demonstrate preliminary efficacy to improve parents’ confidence in talking with their children (communication self-efficacy).
Methods
Study Design, Participants, and Setting
This study was a pilot RCT of FACT vs. waitlist control. Eligible patients were adults with a diagnosis of Stage I - IV (or equivalent) invasive solid tumor who had at least one minor child and were fluent in English. Participants were either a parent (defined as biological, adoptive, foster, or stepparent), primary kin caregiver (defined as a relative or someone with a significant emotional relationship who provides full-time care and nurturing of a child), or legal guardian of a child aged 3 to 17 years. Trained study staff screened patients for eligibility from review of ambulatory oncology clinic schedules and recruited during routine clinical visits at a comprehensive cancer center in North Carolina from August 2022 to December 2022. All participants provided written or verbal informed consent.
Immediately following enrollment, participants were assigned to the intervention or control arm, using a computerized randomization method with an allocation ratio of 1:1 stratified by disease status: advanced stage (stage IV or equivalent) vs. non-advanced. Research assistants informed the participants of their treatment assignment by phone call and email. Participants assigned to FACT were provided with log-in information to the FACT website during this contact and participants assigned to control were informed that they would be given access to the website in 6 weeks (upon completing the post-intervention survey). Study staff then provided each participant with a brief overview of study activities and a brochure that outlined basic information about the FACT intervention, timeline for completion of study surveys, and study contact information. Participants completed study surveys electronically (via a secure link) or using pen and paper at the following timepoints: pre-intervention baseline (T0), 3-week mid-intervention (T1), and 6-week post-intervention (T2). Participants received up to $80 for taking part in this study. Specifically, they received $20 for completing each of the three study surveys and $20 for participation in an optional semi-structured interview. The study was approved by the University of North Carolina at–Chapel Hill Institutional Review Board and registered with clinicaltrials.gov (NCT05377749).
FACT Intervention
Participants assigned to the intervention condition received six weeks of the FACT web-based intervention in addition to usual care (described below). FACT utilizes computer-tailored algorithms and a >1000 message library, to provide individually tailored communication guidance based on responses that participants provided at the time of their first log-in to the FACT website about their cancer and children (tailoring assessment). An example of tailored communication guidance is shown in Supplemental Figure 1. FACT content, including specific language suggestions and practical strategies for engaging and responding to their child, was organized into six modules (First conversations, Sharing new information, Talking about the future, Checking in with your child, Conversations with other adults, Answering questions) that participants accessed in a self-directed manner (i.e., self-paced, in any order). To minimize differences in attention given to the intervention and waitlist control arms, as well as to mimic how we intend FACT to be used in the ‘real world’, participants were not provided with prompts encouraging them to use the FACT website.
FACT content was designed by a multidisciplinary team based on a comprehensive review of the literature, their clinical experiences and previous research studies, and feedback provided by a patient-caregiver-clinician review board.23 FACT is guided by two conceptual frameworks for which self-efficacy is the central construct: The Health Disclosure Decision-Making Model (DD-MM)26 and Social Cognitive Theory (SCT).27 DD-MM, a conceptual framework for understanding decisions to share health-related information with others, proposes that individuals’ decisions to disclose or conceal a health condition are influenced by: 1) illness assessments; 2) the intended recipient; and 3) disclosure (communication) self-efficacy (i.e., the confidence to share the information). DD-MM factors informed the FACT tailoring assessment (Supplemental Table 1). SCT is a framework for understanding adoption, initiation, and maintenance of health behaviors. It posits that behavior change is initiated and maintained when individuals feel that they can execute a desired behavior (self-efficacy) and have a reasonable expectation that the behavior will result in a desired outcome. SCT principles of self-efficacy, outcome expectations, and self-regulation27 guided content and organization of customized feedback (Supplemental Table 2).
We have previously described findings from a single-arm trial of FACT delivered face-to-face.23 Our original FACT intervention was adapted to the web-based format used in the current trial through collaboration with University of North Carolina’s Connected Health Applications and Interventions (CHAI) Core, leveraging their expertise in digital health intervention development to guide selection of images that maximize relevance, use of color for complex information cues, insight-based visual metaphors, and electronic design complexity. We then conducted iterative user and prototype testing of the FACT website with a convenience sample of 15 parents and a patient-caregiver stakeholder advisory board to further refine its content and usability into the final version tested in this study.
Waitlist Control
Participants in the waitlist control condition received usual care during the 6-week study period, after which they were provided with access to FACT. Usual care at the study site, which is similar at other comprehensive cancer centers, includes: 1) access to the cancer center psychosocial support program that is initiated by provider referral or patient request; and 2) access (provided via an internet link) to institution-specific, standardized resource materials (e.g., patient reference guide about resources, navigating appointments, care teams).
Data Collection and Measures
Sociodemographic and clinical characteristics
At baseline, participants provided demographic information including educational level, household income, and age and number of children, as well as their own appraisal of their performance status.28 Study staff collected diagnosis and treatment information from the electronic medical record.
Feasibility
Feasibility metrics, including recruitment (% of approached participants who enrolled) and retention rates (% of enrolled participants who completed T2 assessments) and reasons for study refusal and drop out, were collected to prepare for a future, fully powered-efficacy RCT. While we did not establish a priori criteria for feasibility, based on our prior work with parents with cancer,23 we anticipated that we would be able to enroll 55 participants over six months (~10/months) and that at least 40 participants would complete T2 assessments (retention rate: 73%).
Acceptability
Acceptability, the primary outcome for our trial, was assessed at T2 among FACT arm participants, using the FACT satisfaction questionnaire and post-intervention interviews. The FACT satisfaction questionnaire assessed intervention helpfulness, importance, usability, understandability, relevance, and overall satisfaction on a 4-point scale (0–3), resulting in a total score ranging from 0 to 18. A priori criterion for acceptability was a score of ≥12 (corresponding to participants being at least ‘somewhat satisfied’ overall with FACT) by 75% or more of FACT participants.
Semi-structured interviews were also offered to all FACT participants at T2 to provide additional information about the acceptability of FACT and opportunities to further improve our intervention. Interviews were audio-recorded, professionally transcribed (Rev v 4.16), and reviewed and cleaned by four study team members (AC, EP, PP, HW) to prepare for analysis. Rapid qualitative analysis (RQA)29–31 was performed by four team members (MM, ZN, DR, JY). First, responses to each of the interview items were categorized into domains using a consensus approach. A summary template, organized by domain, was developed to capture parent quotes and related interview themes. Two transcripts were reviewed by the four-member team to ensure consistency in analysis. The remaining transcripts were reviewed, and summary templates were completed in duplicate. Finally, the entire team met to review summary templates from individual participants, reach consensus, and organize the summaries into a single domain matrix to facilitate interpretation.
Communication Self-efficacy
The Communication Self-Efficacy Scale (CSES) was used as the primary efficacy outcome, and completed by participants at T0, T1, and T2, to measure parents’ confidence in communicating about their illness with their children. We chose to focus on self-efficacy, as it is a central construct in both the DD-MM and SCT models, one of the most powerful predictors of behavioral change,32 and influences mental health of parents and their children.33,34 The CSES was minimally adapted from the original scale developed for women with HIV, to contain nine statements rated on a 0 to 100 visual analogue scale where higher scores reflect more confidence. The scale demonstrates high reliability, sensitivity to change, and predictive validity regarding parental communication behaviors, anxiety, and their children’s anxiety.35–37
Communication Beliefs and Behaviors
At T0, T1, and T2, participants completed the Parental Cancer Communication Questionnaire (PCCQ), a 27-item investigator-developed questionnaire assessing the frequency and content of parents’ communication beliefs and behaviors, including the content of the parent’s conversation (e.g., “I have told my child I have cancer”), parent’s concerns about communication, and perceived outcomes of these conversations (e.g., child’s reactions, parental satisfaction). We adapted PCCQ items from other studies of parental communication and illness.36,38 To that end, as we have previously published,23 the PCCQ is intended to provide details about parents’ communication beliefs and behaviors, and thus interpreted on an individual item-level rather than as an overall metric of the quality of communication beliefs and behaviors.
Depression and Anxiety Symptoms
The Patient Health Questionnaire-2 (PHQ-2) is a validated measure of depressive symptoms, commonly used in populations with medical conditions. The PHQ-2 contains two items with a total score ranging from 0–6 and higher score representing worse symptoms.39 The Generalized Anxiety Disorder 7 (GAD-7) is a validated measure of anxiety symptoms. The GAD-7 total score ranges from 0 to 21 with higher scores being worse and a cut-off of 10 typically used to identify cases of GAD.40 These were also completed by participants at T0, T1, and T2 to explore if FACT might indirectly improve parental mental health, as has been shown in prior communication intervention trials.11,12
Sample Size Estimation
With 20 participants in the FACT arm, we were powered to detect the proportion of FACT participants rating our intervention as acceptable with no more than +/− 23% precision. For a rate of 75%, the 95% CI would be 50.9% to 91.3%. For qualitative interview data, sample size estimation is based on projections of the number of participants needed to reach saturation of the concept. The sample size for the proposed study is adequate for qualitative analysis and consistent with psychosocial intervention development.41 This pilot study was not designed nor powered to detect differences in efficacy, but rather to gain preliminary data to estimate effect sizes for a future definitive trial.
Data Analysis
Descriptive statistics were used to characterize participants and examine recruitment, retention, and FACT acceptability scores. The acceptability rate of FACT was reported with an exact binomial 95% CI. Marginal models were used with generalized estimating equation methods to assess differences in CSES, GAD-7, and PHQ-2 scores between groups as well as the differences in changes in these measures over time between groups. All longitudinal models included the following covariates: time, the grouping variable (FACT vs. Control), and the interaction between time and the grouping variable. Results were considered significant at the p<0.05 level. Fisher’s exact tests were used to compare communication behaviors and beliefs separately at T0 and T2. Analyses were conducted using SAS statistical software v9.4 (Cary, NC).
Results
Participant Characteristics
The mean age of participants was 44 years old (Table 1). The majority were female (81%) and White (65%). On average, participants had between 2 and 3 children with the average age of the youngest child being 10 years old. The most common cancers were breast (47%), head and neck (17%), and gynecologic (13%), and more than half had metastatic disease. Almost all were receiving treatment, and treatment goals described in chart review were curative for 43%, and address disease control and palliation for 30% and 26% of participants, respectively. Characteristics were similar between study arms outside of the number of participants receiving treatment for palliative reasons (3 in the FACT arm vs. 9 in the control arm).
Table 1.
Participant Characteristics
| N (%) | |||
|---|---|---|---|
|
| |||
| Overall (n=47) | FACT (n=24) | Control (n=23) | |
|
| |||
| Age, years, mean (SD) | 43.7 (6.3) | 43.2 (6.6) | 44.3 (6.1) |
|
| |||
| Number of children, mean (SD) | 2.6 (1.2) | 2.6 (1.2) | 2.5 (1.3) |
|
| |||
| Age of youngest child, years, mean (SD) | 10.1 (4.4) | 9.6 (4.5) | 10.7 (4.3) |
|
| |||
| Sex | |||
| Male | 9 (19) | 6 (25) | 3 (13) |
| Female | 38 (81) | 18 (75) | 20 (87) |
|
| |||
| Race | |||
| Black or African American | 11 (24) | 7 (29) | 4 (18) |
| White | 30 (65) | 15 (63) | 15 (68) |
| Mixed | 2 (4) | 1 (4) | 1 (5) |
| Asian | 2 (4) | 1 (4) | 1 (5) |
| Native Hawaiian or other Pacific Islander | 1 (2) | 0 (0) | 1 (5) |
|
| |||
| Ethnicity | |||
| Hispanic/Latino | 2 (4) | 0 (0) | 2 (9) |
| Not Hispanic Latino | 45 (96) | 24 (100) | 21 (91) |
|
| |||
| Education | |||
| Less than high school | 3 (6) | 3 (13) | 0 (0) |
| High school | 3 (6) | 2 (8) | 1 (4) |
| Associate’s degree, or 2-year-degree | 7 (15) | 2 (8) | 5 (22) |
| Some college | 9 (19) | 4 (17) | 5 (22) |
| College degree | 13 (28) | 7 (29) | 6 (26) |
| Graduate degree | 12 (26) | 6 (25) | 6 (26) |
|
| |||
| Employment | |||
| Working full-time | 20 (43) | 12 (50) | 8 (35) |
| Working part-time | 4 (9) | 2 (8) | 2 (9) |
| Stay-at-home caregiver | 8 (17) | 1 (4) | 7 (30) |
| Full-time student | 1 (2) | 0 (0) | 1 (4) |
| Disabled or too ill to work | 7 (15) | 4 (17) | 3 (13) |
| Retired | 2 (4) | 2 (8) | 0 (0) |
| Other | 5 (11) | 3 (13) | 2 (9) |
|
| |||
| Household Income | |||
| < $25,000 | 9 (20) | 5 (21) | 4 (18) |
| $25,000–$49,999 | 5 (11) | 2 (8) | 3 (14) |
| $50,000–$74,999 | 6 (13) | 1 (4) | 5 (23) |
| $75,000–$99,000 | 4 (9) | 3 (13) | 1 (5) |
| $100,000 or more | 22 (48) | 13 (54) | 9 (41) |
|
| |||
| Cancer type | |||
| Breast | 22 (47) | 12 (50) | 10 (44) |
| Colorectal | 2 (4) | 1 (4) | 1 (4) |
| Other GI cancers | 1 (2) | 1 (4) | 0 (0) |
| Head and neck | 8 (17) | 2 (8) | 6 (26) |
| Gynecologic | 6 (13) | 3 (13) | 3 (13) |
| Genito-urinary | 4 (9) | 3 (13) | 1 (4) |
| Melanoma | 3 (6) | 1 (4) | 2 (9) |
| Lung | 1 (2) | 1 (4) | 0 (0) |
|
| |||
| Stage | |||
| 1 | 1 (2) | 1 (4) | 0 (0) |
| 2 | 8 (17) | 4 (17) | 4 (17) |
| 3 | 10 (21) | 4 (17) | 6 (26) |
| 4 | 26 (55) | 15 (63) | 11 (48) |
| Other | 2 (4) | 0 (0) | |
|
| |||
| Time since diagnosis, months, mean (SD) | 13.8 (23.3) | 13.0 (18.1) | 14.6 (28.1) |
|
| |||
| Receiving treatment at time of enrollment | |||
| Yes | 45 (96) | 23 (96) | 22 (96) |
| No | 2 (4) | 1 (4) | 1 (4) |
|
| |||
| Goal of Treatment | |||
| Curative | 20 (43) | 11 (46) | 9 (39) |
| Control | 14 (30) | 10 (42) | 4 (17) |
| Palliative | 12 (26) | 3 (12.5) | 9 (39) |
| Unknown | 1 (2) | 0 (0) | 1 (4) |
|
| |||
| ECOG status | |||
| 0 | 9 (19) | 7 (29) | 2 (9) |
| 1 | 31 (66) | 13 (54) | 18 (78) |
| 2 | 4 (9) | 2 (8) | 2 (9) |
| 3 | 3 (6) | 2 (8) | 1 (4) |
Feasibility
Implementation and evaluation of FACT in a pilot trial was feasible. Over a five-month recruitment period, 66 potential participants approached, 48 enrolled (73%) and 47 were randomized to FACT (n=24) or waitlist control (n=23) (Figure 1). Reasons for refusal were logistics or perceived burden (n=7) or lack of perceived relevance (n=4); none cited the randomized design as a reason for non-participation. Forty (FACT: n=23; control: n=17) of the 47 randomized (85%) participants completed T2 assessments, and five participants randomized to FACT did not access the FACT website during the study period.
Figure 1. CONSORT Diagram.
Acceptability
Seventy-eight percent (18 of 23; 95% CI: 56%, 93%) of FACT arm participants rated FACT as acceptable. Among the 12 FACT arm participants who agreed to semi-structured interviews, feedback paralleled quantitative acceptability scores and a few key themes emerged. First, most reported that FACT was very usable, with multiple descriptions of the website being easy to navigate, well-organized, visually appealing, and having clear language: “it was very easy to use and visually appealing and easy to navigate…I thought the colors were right. It was welcoming.” Second, many described FACT as helpful, including in raising awareness of the importance of cancer-related conversations with their children, enhancing confidence and preparedness to approach these conversations, and decreasing distress: “I enjoyed it [FACT] because it gave me a start. It gives me a starting point when I’m at a loss for words…it gave me a way to word it correctly I guess I should say. Especially when it came to…my youngest” (parent of 6-, 11-, and 12-year-old children). Third, most participants, highlighted the importance of tailored guidance to each child’s age and personality: “…I had no idea what to tell them. The diagnosis was shocking and we didn’t know what to say and so I thought that it was really beneficial because you could plug in the exact ages of your child, their personality and they come up with the play of what you should say, the questions and how you could answer them” (parent of 7- and 9-year-old children). One parent of a 5-year-old commented that they updated their child’s age in the tailoring assessment as the child approached their sixth birthday to ensure that the guidance they received was as developmentally-appropriate as possible. By comparison, a parent of a 14-year-old child highlighted their child’s discomfort in discussing sex-specific anatomy. Finally, some participants described inadequately met needs, including wanting additional embedded links to credible, trusted resources and images, videos, and testimonials from other parents, more information about specific topics (e.g., genetic testing and cancer risk), and wanting the FACT to more explicitly involve other adults (e.g., coparents) in these conversations. Qualitative data from individual participants are presented in Supplemental Table 3.
Communication Self-Efficacy, Beliefs, and Behaviors
CSES scores did not significantly differ between FACT (n=24) and control arms (n=23) at baseline (80.8 vs. 79.5, p=0.79). The improvement in CSES scores for the FACT arm between each 3-week time period was 4.8 points (p=0.004), whereas the change in the score for the control group between each 3-week time period was 0.3 points (p=0.83). CSES scores were significantly different between FACT and control groups at T2 (p=0.01) with model-estimated scores of 80.2 in the control group vs. 90.3 in the FACT group (Figure 2).
Figure 2. Changes in Communication Self-Efficacy Scale (CSES) scores over time in cancer patients receiving FACT vs. waitlist control.
At baseline, only two participants reported not having had any type of illness-related conversation with their children. However, at baseline, only 42% of FACT participants and 39% of control participants had told their children explicitly that they have “cancer”. By T2, FACT participants were more likely than controls to have told their children that they have cancer (83% vs. 52%, p=0.03) and reported feeling more prepared to answer their children’s questions about their cancer (p=0.02). FACT participants showed non-significant trends toward being less worried about talking with their children about their cancer, feeling that their children responded better than expected to these conversations, and being more optimistic about how future conversations would go. However, FACT participants were not more likely to discuss or feel more prepared to discuss their prognosis and treatment with their children. They also expressed similar concerns as control participants about being able to manage their own emotions during these conversations. Select items are presented in Table 2 and the complete list is provided in Supplemental Table 4.
Table 2.
Communication beliefs and behavior differences between FACT and waitlist control participants at post-intervention
| p | |||||
|---|---|---|---|---|---|
| How worried do you feel about talking with your child about your cancer? | Not at all | A little | Somewhat | Very | 0.07* |
| FACT | 39.1% | 43.5% | 17.4% | 0.0% | |
| Control | 17.6% | 35.3% | 23.5% | 23.5% | |
| How prepared do you feel to answer your children’s questions? | A little | Somewhat | Very | 0.02** | |
| FACT | 4.5% | 18.2% | 77.3% | ||
| Control | 0.0% | 58.8% | 41.2% | ||
| How well do you think the conversations will go? | Not so well | Somewhat well | Very well | 0.05* | |
| FACT | 4.5% | 50.0% | 45.5% | ||
| Control | 11.8% | 76.5% | 11.8% | ||
| In the time since your diagnosis, have you told your child that you have cancer? | Yes † | No | 0.03** | ||
| FACT | 83.3% | 16.7% | |||
| Control | 52.2% | 47.8% | |||
| How do you feel like your child responded to the conversation(s)? | About how I expected | Better than expected | 0.09* | ||
| FACT | 42.1% | 57.9% | |||
| Control | 73.3% | 26.7% | |||
| What concerns do you have about talking with child about your cancer?...that my child will be worried | Yes | No | 0.05* | ||
| FACT | 65.2% | 34.8% | |||
| Control | 94.1% | 5.9% | |||
| What benefits do you see in talking with your child about your cancer? I will worry less about my child overhearing information | Yes | No | 0.03** | ||
| FACT | 87.0% | 13.0% | |||
| Control | 52.9% | 47.1% |
0.05≤p<0.1
p<0.05
Given the timeframe implied by the wording of this item (i.e., ‘In the time since your diagnosis...’), includes ever responding ‘yes’ at T0, T1, or T2. All other items are specific to the T2 post-intervention timepoint.
Anxiety and Depression
There were no differences in change between groups over time or at T2 for anxiety (p=0.10, p=0.95, respectively) or depression (p=0.55, p=0.90, respectively).
Discussion
The present study assessed the feasibility, acceptability, and preliminary efficacy of FACT – a web-based psychoeducational intervention that provides individually-tailored guidance to parents with cancer to improve communication between them and their children. Results indicate that FACT is both feasible and well accepted by parents with cancer who have young children. In addition, results show potential for efficacy in this population. Over a six-week period, compared to controls, parents who received FACT reported significantly greater self-efficacy in communicating with their children. Semi-structured interviews provided additional information to support that FACT is usable, helpful, and of the importance of communication guidance that is tailored to the age and personality of the child.
To prepare for a future, definitive, phase III trial, it was critical in this study to confirm feasibility and acceptability of our RCT, as well as gain additional information to inform modifications to our intervention. Beyond the favorable overall rates of recruitment (73%) and retention (85%), a few details are notable. The first relates to the generalizability of our study population. One-third was non-White, almost half did not have a college degree, and participants had a wide range of household incomes. Regarding cancer characteristics, although 47% had breast cancer, eight different cancers were represented. Over 75% of participants had stage III or IV disease, but all stages were represented, with relatively equal distribution of participants receiving curative, control, or palliative treatment. Of note, five participants assigned to FACT never accessed the website. While the reasons for non-use are not known, one possible reason was that because participants were informed that they would have access to FACT indefinitely, some may not have felt urgency to utilize the website during the relatively brief study period. We also emphasize that 23 of 24 FACT participants completed post-intervention measures, suggesting a high degree of engagement in our study.
Responses to our acceptability scale, which assessed how helpful, important, easy to use, easy to understand, the degree to which it addressed communication needs, and overall satisfaction, revealed that 78% of participants rated FACT as either ‘somewhat’ or ‘very’ acceptable. These quantitative findings align with our semi-structured interview data in which multiple participants described the high degree of usability of the FACT website and overall feeling that FACT improved their ability and confidence to have discussions related to their illness with their children. Regardless of the age of their children, parents uniformly emphasized the importance of FACT’s tailored language in ways that were developmentally appropriate. Parents also described unique needs according to their children’s developmental age (e.g., discomfort discussing sex-specific anatomy with teenagers, additional support for discussions about genetic testing and cancer risk with older children). Participant interviews also revealed some opportunities to improve FACT, including adding functionality to share access with other adults who may be involved in illness-related conversations (e.g., co-parents, grandparents) and embedding the website with videos of parents modeling conversations and with additional links to other resources relevant to parents with cancer.
Regarding FACT efficacy, we observed improvements in communication self-efficacy that were not only statistically significant but also of sufficient magnitude to suggest a meaningful difference. Specifically, there is no established minimum clinically important change in the CSES, but scores in the FACT group improved by >0.5 SD, a well-accepted metric for clinically significant improvement across multiple behavioral outcomes.42 FACT participants were also more likely to have told their children that they have cancer and felt more prepared to answer their children’s questions about cancer. We also acknowledge that several communication behaviors, including discussing details about their cancer, such as prognosis and treatment, were not significantly better among FACT participants and future study is needed to clarify the potential impact of FACT beyond improvements in communication self-efficacy.
Clinical and Research Implications
Our study of FACT is among the first RCTs to facilitate communication between parents with cancer and their children. Unlike prior communication interventions, FACT is tailored to provide developmentally appropriate information to children, based on their age and maturity, as well as adapt to unique features of the parent’s cancer and changes in the disease course. As it relates to its potential clinical integration, we emphasize that FACT is focused on improving communication, rather than addressing the myriad of difficulties that parents with cancer experience, and that FACT is not intended to be a substitute for psychotherapy with a psycho-oncology trained mental health clinician. Importantly, however, FACT delivers intervention content in a completely asynchronous, web-based format, without relying on the availability of an interventionist, thus minimizing a key barrier to scalability and dissemination across cancer treatment settings.
Limitations
There are a few key limitations to acknowledge that provide opportunities for future modification. This study did not assess or evaluate outcomes among children, spouses, or other caregivers. We made this decision due to concern that this requirement might limit and bias the population of parents with cancer willing to enroll and, in turn, lessen the generalizability of our findings. However, we recognize the importance of outcomes among children and other family members and plan to incorporate this in future work. We also recognize the need to examine the benefits of FACT over a longer period of observation.
Conclusions
In summary, we have confirmed the feasibility and acceptability of FACT, a web-based communication intervention for parents with cancer and their children, and additionally demonstrated its promise to improve communication self-efficacy. We next plan to test an appropriately powered RCT of FACT, with an efficacy measure as the primary objective, in which we will also examine effects on co-parent and family psychosocial outcomes (e.g., anxiety, depression, parenting concerns, quality of life, and family functioning).
Supplementary Material
Acknowledgements
The authors wish to gratefully acknowledge the individuals who participated in this study and gave their time to share their experiences.
Funding
The project was supported by the National Institutes of Health (NIH) through Grant Award 5K07CA218167 (Park) and the Foundation of Hope (Park).
Footnotes
Conflict of Interest
The authors have no conflicts of interest to declare.
Data Availability Statement
The protocol is available at clinicaltrials.gov. Data that support the findings of this study are available from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The protocol is available at clinicaltrials.gov. Data that support the findings of this study are available from the corresponding author upon reasonable request.