NCT04813276

Efficacy of a Self-advocacy Serious Game Intervention

Active, enrolled Phase 2 Last updated 12 February 2026

What this trial tests

Phase 2 trial testing Strong Together serious game in Self-Management in 336 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 August 2022

Primary endpoint
30 June 2026

31 December 2026

Quick facts

Lead sponsor	University of Pittsburgh
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	336
Start date	22 August 2022
Primary completion	30 June 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Strong Together serious game
• Enhanced Care as Usual

Conditions studied

• Self-Management — all drugs for Self-Management →
• Quality of Life — all drugs for Quality of Life →

Sponsor

University of Pittsburgh

Who can join

18 and older, female only, with Self-Management or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Testing the effects of the Strong Together self-advocacy serious game among women with advanced cancer: Protocol for the STRONG randomized clinical trial.
   Thomas TH, Bender C, Rosenzweig M, Taylor S, et al · · 2023 · cited 1× · PMID 36379436 · DOI 10.1016/j.cct.2022.107003