The feasibility, acceptability, and preliminary efficacy of a self-advocacy serious game for women with advanced breast or gynecologic cancer
Abstract
Background
Cancer clinicians and systems aim to provide patient-centered care, but not all patients have the self-advocacy skills necessary to ensure their care reflects their needs and priorities. This study examines the feasibility, acceptability, and preliminary efficacy of a self-advocacy serious game (an educational video game) intervention in women with advanced breast or gynecologic cancer.
Methods
Women with recently diagnosed (<3 months) metastatic breast or advanced gynecologic cancer were randomized 2:1 to receive a tablet-based serious game (Strong Together) (n = 52) or enhanced care as usual (n = 26). Feasibility was based on recruitment, retention, data completion, and intervention engagement. Acceptability was assessed via a postintervention questionnaire and exit interview. Preliminary efficacy was assessed on the basis of change scores from baseline to 3 and 6 months in self-advocacy (Female Self-Advocacy in Cancer Survivorship Scale) using intention-to-treat analysis.
Results
Seventy-eight women (55.1% with breast cancer; 44.9% with gynecologic cancer) were enrolled. Feasibility was demonstrated by satisfactory recruitment (69% approach-to-consent rate; 93% enroll-to-randomize rate), retention (90% and 86% at 3 and 6 months, respectively; 85% data completion), and intervention engagement (84% completed ≥75% of the game). Participants endorsed the intervention’s (75%) and trial’s (87%) acceptability. Participants in the intervention group experienced significant improvements in self-advocacy at 3 and 6 months compared to participants in the control group.
Conclusions
Strong Together is feasible and acceptable among women with advanced breast or gynecologic cancer. This intervention demonstrates promising evidence of clinical efficacy. A future confirmatory trial is warranted to test the efficacy of the intervention for patient and health system outcomes.
INTRODUCTION
Achieving patient-centered cancer care requires patients to have the requisite skills to know, share, and enact their values and priorities relative to their cancer diagnosis and treatment.1 Patient-centered care is particularly critical when concerns arise during major treatment decisions, new or persistent side effects from treatment, or quality-of-life concerns. Patient self-advocacy is a skill set that allows patients to fully engage in patient-centered care to ensure their needs are met when experiencing challenges in their cancer care.2
Self-advocacy interventions are lacking, and most interventions that exist are not based on frameworks that define the predictors, key attributes, and outcomes of self-advocacy.3, 4 Interventions that target both patients and clinicians to improve patient-centered care have shown moderate efficacy, although they focus on improving outcomes within a single clinic visit rather than enhancing patients’ overall skill sets.5 Conversely, interventions that require patients to attend additional appointments with researchers or clinicians may not be feasible or sustainable in the advanced cancer setting.
Identifying these gaps, our team of clinicians, researchers, patient advocates, and advocacy organizations developed a self-advocacy intervention on the basis of our previous work examining self-advocacy in women with cancer.2, 6, 7 Women newly diagnosed with advanced cancer may have the most to gain from learning self-advocacy skills as they quickly face challenges developing treatment plans, managing symptoms and side effects of the cancer and treatment, and dealing with the interpersonal and psychosocial impacts of cancer.8-10 In contrast to less intensive paper-based patient education or more intensive one-on-one training with a professional, we attempted to exploit the immersive nature of serious game technology to provide engaging, motivational self-advocacy skills training that patients could complete remotely at their convenience.11 Serious games are games that both provide entertainment and address serious goals such as education or training. By leveraging key elements of games—presenting an overall goal, providing rules, and implementing a feedback system—users of serious games immerse themselves in creative, enjoyable experiences that also result in knowledge and growth.12 A growing body of research demonstrates that serious game interventions are effective at improving self-management and knowledge acquisition in patients with cancer.13, 14
Given the current lack of theory-guided self-advocacy interventions and few serious game interventions that target patients with cancer (most of which are nonrandomized and have small sample sizes),15 it is critical to assess whether women with advanced cancer perceive this intervention as relevant and useful to gaining important self-advocacy skills. Although our team previously tested initial prototypes of Strong Together, a serious game intervention, during our user-centered design process with stakeholders,16 we had not systematically assessed the intervention’s feasibility, acceptability, and preliminary efficacy. This information is critical because it helps to determine whether a full-scale, confirmatory trial is justifiable and provides critical information to inform the design and conduct of a robust clinical trial.17
The aim of this pilot randomized clinical trial was to assess the feasibility, acceptability, and preliminary efficacy of a novel, low-intensity, real-world serious game intervention (Strong Together) compared to enhanced care as usual for women newly diagnosed with advanced breast or gynecologic cancer. On the basis of a priori feasibility and acceptability benchmarks, it can be determined whether a full-scale version of the trial would be warranted for these patient populations.
MATERIALS AND METHODS
We designed all aspects of the pilot study’s design, sample, procedures, and management to align with the anticipated procedures of a larger, full-scale efficacy trial with adequate statistical power to conduct formal hypothesis testing.17 This allowed us to systematically evaluate all protocol procedures with the goal of identifying strategies to improve the subsequent study’s procedures.
Participants
Eligible participants were women ≥18 years old who had (1) metastatic breast cancer or stage III or IV gynecologic cancer diagnosed within the past 3 months, (2) an Eastern Cooperative Oncology Group performance status of ≤2, which indicated an ability to engage in self-care even if unable to work, (3) a 6-month life expectancy minimum per their oncologist, and (4) English literacy. Patients were excluded if they had either (1) a referral to hospice at the time of recruitment, (2) an active, unstable mental health disorder, or (3) impaired cognition on the basis of the medical record (e.g., Alzheimer disease or dementia) or oncologist.
Understanding that our sample size was not powered to determine intervention effects, we followed guidance on determining a sufficient sample size for pilot clinical trials.18-21 On the basis of projected patient volume and time constraints for accrual, a sample of N = 81 stratified by cancer type (breast vs. gynecologic) was targeted for a final sample of n = 66 with follow-up to 6 months, with anticipation of up to 18.5% attrition in this population of serious illness and high disease burden. We tried to maximize the level of precision by which to detect a meaningful difference in outcomes by limiting our margins of error. With this sample size, we limited the margins of error (in terms of the half-width of the confidence interval [CI]) for the estimation of means to 0.246σ (or 0.304σ for the intervention group and 0.443σ for the enhanced care as usual [ECAU] group), where σ is the population standard deviation for the continuous type variable of interest with 95% confidence. When we estimated proportions (aim 1) to summarize categorical feasibility parameters (e.g., attrition at 6-month follow-up), this sample size allowed us to limit the margin of error to 0.126 for the total sample (or 0.155 for the intervention group and 0.218 for the ECAU group), conservatively assuming a base proportion of 0.50 with 95% confidence. We stopped recruitment after 78 participants enrolled because our attrition data were lower than expected. We selected 2:1 randomization to the Strong Together intervention or ECAU group to maximize data on the intervention.18, 19
Procedures
The University of Pittsburgh Institutional Review Board approved the study protocol (STUDY19050104), and the trial is registered with clinicaltrials.gov (NCT03339765). We recruited participants from the University of Pittsburgh Medical Center Hillman Cancer Center, a National Cancer Institute–designated comprehensive cancer center. The breast and gynecologic cancer clinics at the Hillman Cancer Center are located within Magee-Womens Hospital. All participants provided written, signed informed consent before engaging in any research activities.
Research staff identified potential participants by reviewing weekly clinic lists and referrals from clinicians. Once patients were screened as eligible, research staff verified patient eligibility with the oncology team. A member of the oncology team introduced the study to eligible patients, and if the patient was interested, research staff met the patient during a regularly scheduled clinic visit to introduce the study, assess interest, and conduct the informed consent procedures. Afterward, participants completed baseline measures and were randomized to one of the two groups.
Intervention
Participants randomized to the intervention group received an Amazon Fire tablet with the Strong Together self-advocacy serious game preloaded as an application. We also installed the ES File Manager application to track game usage statistics.
The Strong Together intervention introduces users to several female characters with cancer. Each character’s story is broken up into 10- to 20-minute sessions, each focusing on different challenging situations common in advanced cancer (e.g., symptom management, treatment decisions, and social issues). Within each session, users make multiple decisions for the characters to keep them healthy and strong. Users’ decisions are designed to interweave behavioral examples of the three key self-advocacy skills (making informed decisions, communicating effectively with health care providers, and building strength via connection to others). Users’ decisions drive the narrative flow of the game, with decisions reflecting self-advocacy resulting in the character having a higher quality of life and function (demonstrated via explicit and implicit feedback). The end of each session reviews their decisions and provides explicit ways in which to self-advocate in real life. Additional details of the Strong Together intervention are reported elsewhere.22
Participants were encouraged to engage with the game at their own pace and suggested to use it once a week and repeat sessions to explore different decisions and outcomes. Participants received a tailored weekly email reminding them to review the serious game with a link to a 4-item self-report survey regarding their usage of the intervention in the prior week. At the end of the 3-month intervention period, participants returned the tablet to the study team so usage data could be extracted.
Enhanced care as usual
Participants randomized to the ECAU group were given a paper guide to self-advocacy during the baseline study visit.4 We selected a guide published by the National Coalition for Cancer Survivorship because it reviews several overlapping topics compared to Strong Together (i.e., communication skills, identifying health information, negotiating treatment decisions, etc.) but lacked the interaction and narrative play of the serious game. The guide is not a part of usual care but is freely available on the internet and representative of patient education women with cancer likely receive encouraging them to be engaged and active in their cancer care. Participants received tailored reminder emails.
Measures
We assessed the feasibility of the trial and intervention via five metrics: (1) recruitment to the trial, (2) retention in the trial, (3) data completion across time points, (4) intervention engagement, and (5) dosage of the intervention received. Table 1 lists each feasibility metric and benchmark, which were based on similar technology-based intervention trials within advanced cancer populations.23-25
| Metrics | Feasibility benchmark | Result |
|---|---|---|
| Recruitment | ≥60% approach-to-eligible rate | 83.4% (121 of 145) |
| ≥60% consent-to-approach rate | 69.4% (84 of 121) | |
| ≥70% randomize-to-consent rate | 92.9% (78 of 84) | |
| Retention | ≥81.5% 6-month follow-up completion | 84.6% (66 of 78) |
| Data completion | ≥80% follow-up surveys completed during 3 and 6 months | 84.6% (132 of 156) |
| Intervention engagementa | Average 60-minute total intervention | 56 minutes (SD, 9.8) (range, 0–274.2) |
| ≥75% complete 8 out of 12 sessions | 84.3% (32 of 38) |
- a Intervention engagement is based on the 38 participants who returned study tablets.
We assessed the acceptability of the serious game intervention with a self-report intervention acceptance measure of technology acceptance. The Post Study System Usability Questionnaire (PSSUQ) is a validated 19-item, 7-point Likert-type measure of technology acceptance based on the technology acceptance model.26 The scale includes three subscales assessing the system usefulness, information quality, and interface quality of the technology. One item asked participants to rank their overall satisfaction with the serious game. For this item, we coded responses of “agree,” “somewhat agree,” and “strongly agree” as indicative of acceptability. Response options (0–6) were recoded so that higher scores indicate higher acceptability. Additional qualitative acceptability results are reported elsewhere.27
Participants completed patient-reported outcome measures at baseline, 3 months, and 6 months. The follow-up time points were selected to determine the immediate and long-term impact of the intervention compared to ECAU. At the follow-up time points, a research assistant sent participants a link to complete surveys on Qualtrics XM, a Health Insurance Portability and Accountability Act–approved electronic survey management software.
For our primary outcome, we measured patient self-advocacy using the Female Self-Advocacy in Cancer Survivorship Scale, which has been shown to be valid and reliable in women with cancer.6 This 20-item Likert-type scale consists of three subscales: informed decision-making, effective communication with health care providers, and connected strength. Each item asks participants’ level of agreement (1 = “strongly disagree” to 6 = “strongly agree”) in whether they perform certain self-advocacy behaviors including preparing to make decisions about their cancer, asking questions if they do not understand something related to their cancer, and accepting help from others. Higher scores (6–120) indicate higher self-advocacy behaviors.
Secondary outcomes included health-related quality of life and symptom burden. We assessed quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G).28, 29 The 27-item FACT-G assesses an individual’s well-being over the past 7 days within the following domains: physical, social, emotional, and functional. Higher scores (0–108) indicate a better quality of life.
The MD Anderson Symptom Inventory captured symptom burden, operationalized as both symptom severity of 13 common cancer- and treatment-related symptoms (0 = “not present” to 10 = “as bad as you can imagine” in the past 24 hours) and the degree to which those symptoms interfered with six aspects of daily living (0 = “did not interfere” to 10 = “interfered completely”).30, 31 Higher symptom severity (0–130) and symptom interference (0–60) indicate a higher symptom burden.
Participant descriptors and covariates
Baseline questionnaires captured patient-level characteristics derived from the self-advocacy conceptual framework that could affect self-advocacy, including depression and anxiety symptoms by using the Hospital Anxiety and Depression Scale (HADS)32, 33 and sociodemographic variables including age, education, and financial burden by using the Center for Research in Chronic Disorders sociodemographic survey.34 Participants’ medical information including cancer diagnosis and treatment history were captured via electronic medical records.
Statistical analysis
Data were first explored for any anomalies (e.g., outliers, missing data, and multicollinearity) that could affect the validity of the results from the statistical analysis performed. We used descriptive statistics to summarize the total sample and each treatment group given the level of measurement and observed data distribution of the variable. In particular, feasibility and acceptability were summarized by using frequency counts and percentages for categorical metrics and means with SDs for continuous type metrics. We compared treatment groups on baseline continuous type characteristics by using independent sample t-tests or Wilcoxon rank sum tests for variables and categorical characteristics by using X2 tests of independence or Fisher exact tests.
We assessed preliminary efficacy by using linear mixed modeling considering baseline, 3-month, and 6-month time points. We selected covariates a priori on the basis of the self-advocacy conceptual framework and adjusted our analyses to account for age, education, financial burden (assessed using a single self-report item of how difficult it was for participants to meet their basic needs), time since advanced cancer diagnosis, and a composite of HADS depression and anxiety scores. From our models, we reported least squares means with standard errors for self-advocacy, symptom burden, and health-related quality of life at each time point and for the change from baseline to the 6-month time point to calculate within-group mean change scores with 95% CIs.
RESULTS
Participant characteristics
Mean participant age was 59.5 years (see Table 2). Most participants were White (87.2%) with an average of 14.2 years of formal education. Fewer than half (34.6%) lived in a household earning less than $50,000 a year. The sample had slightly more participants with breast cancer (55.1%) than gynecologic cancer (44.9%), with the most common gynecologic cancers being ovarian/fallopian/primary peritoneal (68.6%). The mean time from original diagnosis (M, 3.6 years; SD, 6.8) and advanced cancer diagnosis (M, 71.0 days; SD, 37.0) diagnoses to study enrollment reflected that over half (n = 43; 55.1%) experienced at least one cancer recurrence. There were no significant differences in any sociodemographic or clinical characteristics between treatment groups (p ≥ .05).
| Characteristics | Intervention group (n = 52) | Enhanced care as usual group (n = 26) | p |
|---|---|---|---|
| No. (%) | No. (%) | ||
| Age, mean (SD), years | 59.3 (13.0) | 60.0 (10.2) | .79 |
| Race | .24 | ||
| White | 43 (82.7) | 25 (96.2) | |
| Black | 8 (15.4) | 1 (3.8) | |
| Asian | 1 (1.9) | 0 (0) | |
| Ethnicity | .46 | ||
| Latina | 1 (1.9) | 0 (0) | |
| Non-Latina or do not know | 51 (98.1) | 26 (100) | |
| Education, mean (SD), years | 13.9 (2.9) | 14.7 (2.9) | .26 |
| Annual household income | .92 | ||
| $0–$19,999 | 8 (15.4) | 3 (11.5) | |
| $20–$49,999 | 10 (19.2) | 6 (23.1) | |
| $50–$79,999 | 12 (23.1) | 6 (23.1) | |
| $80–$150,000 | 4 (7.7) | 3 (11.5) | |
| >$150,000 | 5 (9.6) | 3 (11.5) | |
| Unknown, decline to answer, or not applicable | 13 (25.0) | 5 (19.2) | |
| Performance status | .70 | ||
| 0 (fully active) | 45 (86.5) | 22 (84.6) | |
| 1 (ambulatory, able to perform light work only) | 6 (11.5) | 4 (15.4) | |
| 2 (ambulatory, unable to perform any work) | 1 (1.9) | 0 (0.0) | |
| Cancer type | .87 | ||
| Breast | 29 (55.8) | 14 (53.8) | |
| Ovarian, peritoneal, fallopian tube | 17 (32.7) | 7 (27.9) | |
| Uterine | 4 (7.7) | 3 (11.5) | |
| Cervical | 1 (1.9) | 1 (3.8) | |
| Vaginal/vulvar | 1 (1.9) | 1 (3.8) | |
| Recurrences | .30 | ||
| 0 | 21 (40.4) | 14 (53.8) | |
| 1 | 23 (44.2) | 11 (42.3) | |
| 2 | 6 (11.5) | 0 (0) | |
| 3 | 2 (3.8) | 1 (3.8) | |
| Time from original diagnosis to enrollment, mean (SD), years | 7.0 (1.0) | 6.2 (1.2) | .37 |
| Time from advanced cancer diagnosis to enrollment, mean (SD), days | 37.8 (5.2) | 35.0 (6.9) | .20 |
| Anxiety symptoms (0–21), mean (SD) | 5.8 (4.5) | 6.3 (4.8) | .65 |
| Depressive symptoms (0–21), mean (SD) | 4.8 (3.9) | 5.4 (4.1) | .48 |
| Difficulty paying for basic needs | 23 (44.2) | 9 (34.6) | .70 |
Feasibility
We successfully recruited 78 participants from December 2018 to September 2020. Recruitment temporarily stopped from mid-March to May 2020 because of the COVID-19 pandemic. Although we were able to successfully enroll the last 12 participants remotely from June to September 2020, the nonresponse rate (13/37; 35.1%) and refusal rate (12/37; 32.4%) during this period negatively affected overall feasibility metrics. Before the pandemic, in-person recruitment had a consent-to-screened eligible rate of 18.9%.
The study achieved all trial and intervention feasibility benchmarks. Figure 1 illustrates the screening and recruitment metrics by using the Consolidated Standards of Reporting Trials diagram. Table 1 reports the feasibility results compared to the a priori benchmarks. In addition to an almost 70% approach-to-consent rate, the study achieved a high retention rate with almost 85% (n = 66) of participants remaining in the study and completing 6-month data collection. Intervention engagement varied, with an observed range of 0–4.5 hours on the serious game with a mean of approximately 1 hour. Despite this variability, approximately 85% completed at least three fourths of the serious game sessions.
Consolidated Standards of Reporting Trials diagram. ECOG indicates Eastern Cooperative Oncology Group.
Of the seven participants (9.0% of the total sample) who withdrew, five (71.4%) did so before the 3-month assessment. Reasons for withdrawal included passively withdrawing (e.g., not responding to at least three contacts from the study team) (n = 3), disease progression (n = 2), and feeling overwhelmed (n = 2). Notably, five of the seven participants (71.4%) who withdrew died within 6 months of withdrawal.
Acceptability
Participants reported strong acceptability of the serious game intervention on the basis of PSSUQ mean scores: usefulness (M, 5.5; SD, 1.0), information quality (M, 5.5; SD, 0.7), interface quality (M, 5.4; SD, 0.9), and overall acceptability (M, 5.4; SD, 0.9). The vast majority (91.8%) of participants reported being “overall satisfied” with the intervention. Of the thirty-six 3-month exit interviews (intervention group only), 27 participants (75.0%) in the intervention reported being “satisfied” or “very satisfied” with the intervention. Of the sixty 6-month exit interviews (both groups), 52 participants (86.6%) reported being “satisfied” or “very satisfied” with the trial. The most common reason for lack of satisfaction with the intervention and/or trial was related to participants feeling they did not need support in self-advocating.
Preliminary efficacy
Table S1 reports the descriptive statistics for self-advocacy for each time point and for the change from baseline to 6 months and the test statistics (as p values) for the main effects of group and time and their interaction for the total sample and by cancer type. In between-group adjusted analyses, there were no group main or group-by-time interaction effects over the 6-month period; however, there was a trend for an overall main effect of improvement over time. In within-group analyses, those in the intervention group had significant improvements in informed decision-making from baseline to 6 months (mean Δ, 0.35; 95% CI, 0.14–0.55). Participants with breast cancer also had significant improvements from baseline to 6 months in effective communication (mean Δ, 0.39; 95% CI, 0.10–0.69) and overall self-advocacy (mean Δ, 0.26; 95% CI, 0.08–0.44). Participants receiving ECAU did not see improvements in any subscales or total self-advocacy at 3 or 6 months. Figure 2 illustrates the within-group changes from baseline to 6 months.
Change in Female Self-Advocacy in Cancer Survivorship (FSACS) scale scores from baseline to 6 months for the total sample and by type of cancer for the (A) total FSACS scale, (B) informed decision-making subscale, (C) effective communication subscale, and (D) connected strength subscale. ECAU indicates enhanced care as usual.
Table S2 reports the descriptive statistics for symptom burden and health-related quality of life for each time point and the change from baseline to 6 months and the test statistics (as p values) for the main effects of group and time and their interaction for the total sample and by type of cancer. Although no significant group-by-time interactions were found (p ≥ .05), significant time main effects (p < .05) were found for the total sample and by type of cancer largely for symptom severity and symptom interference, where both treatment groups showed significant decreases from baseline to 6 months (p < .05). For health-related quality of life, the ECAU group showed a significant decrease from baseline to 6 months for the total sample and for those with gynecologic cancer, whereas no significant change was observed for the intervention group. Additionally, trends for overall between-group differences between groups were observed for symptom severity in the total sample (p = .094) and in those with gynecologic cancer (p = .050), where the intervention group on average tended to report lower symptom severity compared to the ECAU group.
DISCUSSION
Equipping patients to engage meaningfully in their cancer care is a priority for patients, clinicians, and health systems alike. In this pilot study, we found that a low-intensity, real-world serious game intervention designed to teach self-advocacy skills was feasible and acceptable among women with advanced gynecologic or breast cancer. The Strong Together intervention was associated with marginally significant improvements in self-advocacy from baseline to 6 months that warrant further research.
The game’s high acceptability likely derives from the substantial time put into developing the game with patient advocates, representatives from advocacy organizations, and multiple rounds of acceptability testing. This guidance helped ensure that the game, although intending to promote patients’ self-advocacy skills, was designed from the patient’s perspective to reflect real-world challenges that reflect the priorities of real individuals with advanced cancer.35 Also, the intervention was designed to fit the realities of living with advanced cancer, which means that participants were able to freely engage with and use the intervention with no scheduled contact and little guidance beyond email reminders. In consideration of the needs of individuals with advanced cancer as well as of health care systems, this flexible and low-cost intervention balances the challenges of providing services in this population with the desire to provide an engaging experience.
The intervention’s initial efficacy demonstrated that participants receiving the Strong Together intervention saw improvements in self-advocacy that persisted for 6 months. No changes were identified in the ECAU group. Additional data demonstrated that participants in the intervention group reported less severe declines in quality of life and less symptom severity at 6 months compared to the ECAU group. These findings suggest that a larger trial is warranted to explore how self-advocacy evolves over time between and within the intervention and ECAU groups and to explore potential differences between the breast and gynecologic cancer populations.
The recruitment and retention rates were high in this study, even compared to similar intervention studies among patients with advanced cancer.36, 37 This is likely because of the minimal burden associated with participation. The intervention occurred completely on the tablet at times convenient to participants, the intervention was broken up into 15- to 20-minute sessions, and all assessments were done remotely without the need for clinic or in-person time. This remote study design was particularly effective during the pandemic, when in-person recruitment and data collection were restricted, and should be considered in future trials when practical.38
Serious games have demonstrated the potential for promoting behavior change and self-management in cancer and palliative care settings, although research is still limited.39 Vulnerable groups especially stand to gain from serious game interventions by providing information and tools to promote healthy behaviors.40 Other technology-based person-centered care interventions have demonstrated acceptability among patients with advanced cancer but have also increased distress in those patients.41 The researchers concluded that this increase is likely due to the transient but necessary result of discussing topics related to advanced cancer.42 Although the Strong Together serious game includes scenarios in which the character’s treatment was no longer effective, most participants were not upset by this scenario, although a few commented that this scenario initially elicited negative or scary thoughts. Given that many participants had been diagnosed with early-stage disease before recurrence to an advanced diagnosis, participants’ receptiveness may reflect their longer experience managing their cancer.
Limitations to this pilot study include recruitment at one large academic cancer center with limited racial/ethnic diversity, which mirrors the center’s catchment rates. This limits our ability to conclude that the intervention and trial would be feasible and acceptable among more diverse patient populations or in community settings. Also, we loaned participants tablets to complete the intervention, which likely affected how they engaged with the intervention, compared to installing the serious game application on participants’ personal devices.
In conclusion, a low-intensity, real-world serious game to teach women with advanced cancer self-advocacy skills demonstrated strong feasibility and acceptability with indication that a larger study may demonstrate efficacy. This promising intervention warrants further testing in a larger sample of individuals to determine whether self-advocacy training can improve individuals’ ability to engage in patient-centered care along with their quality of life and symptom burden.
AUTHOR CONTRIBUTIONS
Teresa Hagan Thomas: Conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, project administration, resources, software, and writing–original draft. Catherine Bender: Conceptualization, supervision, and writing–review and editing. Heidi S. Donovan: Supervision and writing–review and editing. Patty Jo Murray: Data curation, investigation, methodology, project administration, software, and writing–reviewing and editing. Sarah Taylor: Conceptualization, resources, supervision, and writing–review and editing. Margaret Rosenzweig: Conceptualization, resources, supervision, and writing–review and editing. Susan M. Sereika: Conceptualization, formal analysis, resources, software, methodology, writing–review and editing, and visualization. Adam Brufsky: Resources and writing–review and editing. Yael Schenker: Conceptualization, supervision, and writing–review and editing.
ACKNOWLEDGMENTS
American Cancer Society Mentored Research Scholar Award (MSRG-18-051-51); National Palliative Care Research Center Career Development Award; University of Pittsburgh School of Nursing Center for Research and Education Pilot/Feasibility Study Program K24 AG070285/AG/NIA NIH; National Cancer Institute P30-CA47904.
CONFLICT OF INTEREST STATEMENT
Teresa Hagan Thomas has received grants from the Division of Cancer Prevention, National Cancer Institute. Sarah Taylor has been a consultant for AstraZeneca. Yael Schenker has been a consultant for UpToDate and received grants from the National Institutes of Health. The other authors declare no conflicts of interest.
Open Research
DATA AVAILABILITY STATEMENT
Data are available upon reasonable request.
