Efficacy of a Self-advocacy Serious Game Intervention

NCT04813276 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: STUDY21020095
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Self-Management; Quality of Life

Keywords

Self-advocacy

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline in self-advocacy scores on the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale at 3 months

  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.

  Baseline and 3 months

• Mean change from baseline in self-advocacy scores on the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale at 6 months

  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.

  Baseline and 6 months

Secondary Outcomes (6)

• Mean change from baseline in quality of life scores on the Functional Assessment of Cancer Therapy - General (FACT-G) Scale at 3 months

  Baseline and 3 months

• Mean change from baseline in quality of life scores on the Functional Assessment of Cancer Therapy - General (FACT-G) Scale at 6 months

  Baseline and 6 months

• Mean change from baseline in symptom burden scores on the M.D. Anderson Symptom Inventory (MDASI) at 3 months

  Baseline and 3 months

• Mean change from baseline in symptom burden scores on the M.D. Anderson Symptom Inventory (MDASI) at 6 months

  Baseline and 6 months

• Mean change from baseline in patient-perceived patient-centeredness of care scores on the Patient Centeredness of Care Scale (PCCS) at 3 months

  Baseline and 3 months

Other Outcomes (5)

• Changes from baseline in use of healthcare service utilization defined as hospital admissions, emergency room visits, and (un)planned clinic visits at 3 months

  Baseline and 3 months

• Changes from baseline in use of healthcare service utilization defined as hospital admissions, emergency room visits, and (un)planned clinic visits at 6 months

  Baseline and 6 months

• Intervention receipt

  Baseline and 3 months

Study Arms (2)

Serious game intervention

EXPERIMENTAL

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

Behavioral: Strong Together serious game

Enhanced care as usual

ACTIVE COMPARATOR

Participants receive a paper-based self-advocacy guide.

Behavioral: Enhanced Care as Usual

Interventions

Enhanced Care as Usual BEHAVIORAL

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

Strong Together serious game BEHAVIORAL

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.

Serious game intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Inclusion criteria are based on self-reported gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• University of Pittsburgh: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• 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.

  PMID: 36379436 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 24, 2021
• Study Start: August 22, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)