Clinical trial NCT04813276: Efficacy of a Self-advocacy Serious Game Intervention
Official title: Efficacy of a Self-advocacy Serious Game Intervention for Women With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Self-Management
Quality of Life
Keywords: Self-advocacy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2021-03-24
Enrollment: 336
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Individuals with cancer must overcome multiple, ongoing challenges ("self-advocate") related to their cancer experience to receive patient-centered care. Women with metastatic 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 advanced 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Female
* ≥18 years
* Diagnosed with advanced solid organ cancer within the past 6 months being treated with non-curative intent
* Have at least a 6-month life expectancy (as determined by their oncologist)
* Eastern Cooperative Oncology Group performance score of 0 to 2 (per health record or oncologist)
* Able to read and write in English

Exclusion Criteria:

* On hospice at the time of recruitment
* Impaired cognition (per health record)
* Other active, unstable mental health disorder

Primary outcomes:
measure: Mean change from baseline in self-advocacy scores on the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale at 3 months
timeFrame: Baseline and 3 months
measure: Mean change from baseline in self-advocacy scores on the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale at 6 months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Mean change from baseline in quality of life scores on the Functional Assessment of Cancer Therapy - General (FACT-G) Scale at 3 months
timeFrame: Baseline and 3 months
measure: Mean change from baseline in quality of life scores on the Functional Assessment of Cancer Therapy - General (FACT-G) Scale at 6 months
timeFrame: Baseline and 6 months
measure: Mean change from baseline in symptom burden scores on the M.D. Anderson Symptom Inventory (MDASI) at 3 months
timeFrame: Baseline and 3 months
measure: Mean change from baseline in symptom burden scores on the M.D. Anderson Symptom Inventory (MDASI) at 6 months
timeFrame: Baseline and 6 months
measure: Mean change from baseline in patient-perceived patient-centeredness of care scores on the Patient Centeredness of Care Scale (PCCS) at 3 months
timeFrame: Baseline and 3 months
measure: Mean change from baseline in patient-perceived patient-centeredness of care scores on the Patient Centeredness of Care Scale (PCCS) at 6 months
timeFrame: Baseline and 6 months
Other outcomes:
measure: Changes from baseline in use of healthcare service utilization defined as hospital admissions, emergency room visits, and (un)planned clinic visits at 3 months
timeFrame: Baseline and 3 months
measure: Changes from baseline in use of healthcare service utilization defined as hospital admissions, emergency room visits, and (un)planned clinic visits at 6 months
timeFrame: Baseline and 6 months
measure: Intervention receipt
timeFrame: Baseline and 3 months
measure: Intervention mechanism usage
timeFrame: Baseline and 3 months
measure: Intervention mechanism usage
timeFrame: Baseline and v6 months
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
References:
citation: Thomas TH, Bender C, Rosenzweig M, Taylor S, Sereika SM, Babichenko D, You KL, Terry MA, Sabik LM, Schenker Y. Testing the effects of the Strong Together self-advocacy serious game among women with advanced cancer: Protocol for the STRONG randomized clinical trial. Contemp Clin Trials. 2023 Jan;124:107003. doi: 10.1016/j.cct.2022.107003. Epub 2022 Nov 13.