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Participants receive the Strong Together serious game program on a tablet computer.

Participants receive a paper-based self-advocacy guide.

The Strong Together serious game program is an interactive, immersive education program in which participants quickly learn the behaviors of self-advocacy and the potential consequences of self-advocating or not. Participants receive weekly notifications for 12 weeks alerting them that a new serious game session is available and encourage them to complete one session per week.

Strong Together serious game

A self-advocacy patient brochure published by the National Coalition for Cancer Survivorship. This guide is not a part of usual care, but is freely available on the Internet.

Enhanced Care as Usual

Teresa H Thomas, PhD, RN

Individuals with cancer must overcome multiple, ongoing challenges ("self-advocate") related to their cancer experience to receive patient-centered care. Women with metastatic breast or advanced gynecologic cancer often face significant challenges managing their quality of life concerns and cancer- and treatment-related symptoms. If they do not self-advocate to manage these concerns, they risk having poor quality of life, high symptom burden, and care that is not patient-centered. Serious games (video games that teach) are effective health interventions that allow users to vicariously engage in situations reflecting their personal experiences, receive meaningful information, and learn personally relevant skills that they can apply in real life.

The goal of the current study is to test the efficacy of a novel intervention using a serious game platform to teach self-advocacy skills to women with metastatic breast or advanced gynecologic cancer. The Strong Together intervention consists of a multi-session, interactive serious game application with tailored self-advocacy goal-setting and training. The serious game is based on a self-advocacy conceptual framework and applies behavior change theories and serious game mechanisms to promote skill development and implementation. The game works by immersing users in the experiences of characters who are women with advanced cancer; requiring users to make decisions about how the characters self-advocate; demonstrating the positive and negative consequences of self-advocating or not, respectively; and providing multiple, individualized feedback mechanisms and game features to enforce self-advocacy skill acquisition and transference to real life.

Patient-centered care (e.g., incorporating patient preferences, needs, and values into all care aspects) is an essential component of high-quality care, associated with improved patient health, well-being, treatment adherence, and care coordination. Patients cannot participate in patient-centered care if they do not have the skills to self-advocate. Self-advocacy is defined as the ability to overcome health challenges by making informed healthcare decisions, communicating effectively with healthcare providers, and gaining strength through connection to others. Our work established that self-advocacy is associated with higher quality of life, lower symptom burden, higher patient-centered care, and fewer hospital admissions and emergency visits. Self-advocacy is particularly necessary in the advanced cancer setting where patients face numerous health challenges including complex treatment decisions, multiple cancer- and treatment-related symptoms, and poor quality of life. However, many patients struggle to self-advocate because they have not previously needed these skills or do not know how to apply these skills within their cancer experience. Interventions to teach patients self-advocacy are lacking, and the few programs that exist rely on non-interactive patient education that does not leverage behavior change or educational theories. There is a critical need for theoretically grounded interventions to teach patients with advanced cancer self-advocacy skills so that they can address health challenges related to their care and experience improved outcomes.

Technology-based serious games (educational video games) allow users to vicariously engage in situations reflecting their personal experiences, receive meaningful information, and learn personally relevant skills that they can apply in real life. Serious games are an ideal platform for teaching self-advocacy skills because they use immersive, motivational elements and mechanisms to provide highly-relevant skills-training. Serious games improve patient knowledge and skills though their mechanisms of action remain unclear.

Our team developed the Strong Together intervention which teaches self-advocacy skills in a serious game platform. Patients vicariously respond to health challenges managing symptoms, communicating with providers, and managing their health and are then exposed to the positive and negative consequences of self-advocating or not, respectively. It is based on our team's self-advocacy conceptual model, grounded in behavior change and educational theories, and integrates multiple mechanisms to promote learning outcomes. Our valid, reliable self-report self-advocacy measure captures the three dimensions of self-advocacy: informed decision-making, strength through connection, and effective communication. Our pilot randomized clinical trial (RCT) of the Strong Together intervention among N=70 women newly diagnosed with advanced breast or gynecologic cancer demonstrated feasibility (82% completed 6-month surveys, 71% engaged in all intervention sessions) and intervention acceptability (97% satisfied; 90% saw it as useful).

In the current study, the investigators will test the efficacy of the Strong Together intervention compared with an enhanced care as usual group in a larger, more diverse sample of women with advanced cancer.

Inclusion criteria are based on cancer diagnoses which primarily occur in women (gynecological and breast cancer)

Efficacy of a Self-advocacy Serious Game Intervention

Efficacy of a Self-advocacy Serious Game Intervention for Women With Advanced Cancer

Electronic Medical Record and self-report of the number of times the patient has gone to the Emergency Department, been admitted to a hospital, and had (un)scheduled clinic visits within the past three months

Calculation of the time, duration, and intervention content used by participants.

Calculation of differences in primary and secondary outcome measures based on exposure to serious game mechanisms.

The Female Self-Advocacy in Cancer Survivorship (FSACS) Scale is a 20-item, 6-point Likert-type scale (score range: 20-120). The scale is a validated measure of a woman with cancer's ability to engage in informed decision-making, strength through connection, and effective communication with healthcare providers. Higher scores indicate higher self-advocacy.

The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item, 5-point Likert-type scale (score range: 0-108). This scale captures physical, functional, social, and emotional well-being among patients with cancer. Higher scores indicate higher quality of life.

The M.D. Anderson Symptom Inventory (MDASI) is a 19-item, 11-point Likert-type scale consisting of two subscales (score range: 0-190. The first subscale assesses symptom severity of 13 common cancer- and treatment-related symptoms on a scale of 0 to 10. Higher scores indicate higher symptom severity. The second subscale assesses the degree to which symptoms interfere with daily life on a scale of 0 to 10. Higher scores indicate higher symptom interference.

The Patient Centeredness of Care Scale (PCCS) is 14-item, 4-point Likert-type scale (score range: 0-42). This measure assesses patient perceptions of how patient-centered their oncologist interactions are, including the degree the oncologist explores the patient's health and illness experiences and finds common ground.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

University of Pittsburgh

Assistant Professor

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Carcinoma

Endometrial Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Vulvar Diseases

Vaginal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Vaginal Cancer

Vulvar Cancer

Participants randomized to the intervention will receive the Strong Together serious game program on a tablet computer. The goal of this serious game is to teach the participant how to advocate for her needs relate to her cancer and treatment. The research team will send participants weekly notifications for 12 weeks to alert them that a new serious game session is available and encourage them to complete one session per week.

If randomized to the enhanced care as usual arm, the research team will give participants a paper-based self-advocacy patient brochure published by the National Coalition for Cancer Survivorship. This guide is not a part of usual care, but is freely available on the Internet.

The Strong Together serious game program is an interactive, immersive education program in which participants quickly learn the behaviors of self-advocacy and the potential consequences of self-advocating or not. Participants will receive weekly game sessions to play at home for three months.

Self-advocacy, defined as the ability of a patient to get her needs and priorities met in the face of a challenge, is an essential skill but not all women with advanced cancer are able to do it. We want to instruct women with advanced cancer who have low self-advocacy to self-advocate for their health and well-being. We will test a new "serious game" or video program that teaches self-advocacy skills through interactive, situation-based activities. The goal of the Strong Together serious game is to engage participants in challenges commonly experienced by women with advanced cancer, offer them choices to self-advocate or not, and directly show them the health and social benefits of self-advocating and the negative consequences of not self-advocating. Through engaging in the Strong Together program, participants vicariously learn the essential skills of self-advocacy, understand the downstream effects of using or not using these skills, and learn distinct behaviors that they can then use to address their own challenges.

Background: When faced with the challenges of advanced cancer, women must advocate (or stand up) for their needs and priorities. However, there are no interventions to promote self-advocacy among female patients with advanced cancer. Preliminary work has developed a theoretically-based, psychometrically-strong measure of self-advocacy (the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale) and demonstrated correlations with symptom burden and healthcare utilization. Serious games offer a novel mechanism by which to deliver interactive, engaging health education that links users' choices to consequences so that users learn a desired skill. The fully-automated Strong Together self-advocacy serious game may allow women with advanced cancer to learn self-advocacy skills and therefore improve their health outcomes.

Objective/Hypothesis: The purpose of this pilot randomized controlled trial (RCT) is to evaluate the feasibility, acceptably, and preliminary efficacy of the Strong Together serious game.

Specific Aims:

Specific Aim 1: To evaluate the feasibility and acceptability of the 3-month Strong Together intervention.

* Benchmark 1: At least 75% of participants will engage in at least 8 out of the 12 serious game sessions.
* Benchmark 2: At least 80% of participants will find the intervention acceptable based on ratings of perceived satisfaction and ease of use, as well as feedback from qualitative exit interviews.

Specific Aim 2: To explore the differences in self-advocacy and symptom burden between groups over time.

• Research Question: Do patients who receive the intervention report improved self-advocacy and lower symptom burden compared to those assigned to enhanced care as usual?

Study Design: This pilot RCT will recruit (N=84) women from cancer clinics at the University of Pittsburgh Medical Center. Eligibility criteria include: female; age ≥ 18 years; diagnosis of Stage III or IV gynecological or Stage IV breast cancer within the past 3 months; 6-month prognosis; Eastern Cooperative Oncology Group score of 0-1; and ability to read and write in English. Measures will be collected at baseline, 3 months, and 6 months. Randomization (2:1) will occur to the 3-month Strong Together intervention group or the enhanced care as usual group. Feasibility will be assessed by calculating percentages of the intervention's dosage, engagement, recruitment, retention, and data completion. Acceptability will be assessed through exit interviews and an acceptability scale. Preliminary efficacy will be measured by exploring differences in self-advocacy and symptom burden scores and calculating point and interval estimates between the groups at 3 and 6 months.

Cancer Relevance: This study represents a unique opportunity to address the lack of self-advocacy interventions, reduce the risks of women with low self-advocacy, and guide an adequately-powered RCT to educate women with advanced cancer to self-advocate.

Inclusion criteria are based on cancer diagnoses which primarily occur in women (gynecological and breast cancer).

Self-Advocacy Serious Game in Advanced Cancer

Piloting a Serious Game to Improve Self-Advocacy Among Women With Advanced Cancer

We will calculate the number of participants in the intervention group who complete two-thirds (66.7%) of the intervention sessions as a measure of intervention feasibility. We will accept that we achieved adequate feasibility if at least 75% of participants engage in at least eight out of the twelve serious game sessions.

We will accept that we achieved adequate acceptability if at least 80% of participants find the intervention acceptable based on the Post Study System Usability Questionnaire scores and if no issues are raised during the qualitative interviews and feedback that cannot be revised prior to the future trial.

We anticipate that self-advocacy scores will increase (improve) among participants in the intervention group compared to the enhanced care as usual group.

We anticipate that symptom burden scores will decrease (improve) among participants in the intervention group compared to the enhanced care as usual group.

We anticipate that the frequency of healthcare utilization will decrease (improve) among participants in the intervention group compared to the enhanced care as usual group.

We anticipate that quality of life will increase (improve) among participants in the intervention group compared to the enhanced care as usual group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of a Self-advocacy Serious Game Intervention	NCT04813276	Self-Management Quality of Life	Strong Together... Enhanced Care a...	18 Years -	University of Pittsburgh
Self-Advocacy Serious Game in Advanced Cancer	NCT03339765	Ovarian Cancer ... Ovarian Cancer ... Breast Cancer S... Cervical Cancer... Cervical Cancer... Cervical Cancer... Endometrial Can... Endometrial Can... Vulvar Cancer, ... Vulvar Cancer, ... Vaginal Cancer ... Vaginal Cancer ... Vaginal Cancer ...	Strong Together...	18 Years -	University of Pittsburgh

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