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NCT04813276 · ClinicalTrials.gov registry record · Phase 2
Efficacy of a Self-advocacy Serious Game Intervention
A Phase 2 study of Quality of Life and Self-management, sponsored by University of Pittsburgh.
- Active
- Registry status
- Phase 2
- Development phase
- 336
- Enrollment target
- 1
- Study location
NCT04813276: Active Phase 2 study of Quality of Life and Self-management, sponsored by University of Pittsburgh.
NCT04813276 is a Phase 2 study of Quality of Life and Self-management that is active but no longer recruiting, run by University of Pittsburgh. The registered enrollment target is 336 participants, below the 450-participant average among 107 other Quality of Life trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04813276, a Phase 2 study of Quality of Life and Self-management, is active but no longer recruiting, sponsored by University of Pittsburgh.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 336 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Strong Together serious game
- BEHAVIORAL Enhanced Care as Usual
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2022-08-22 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04813276 still lists
NCT04813276 is an interventional study that assigns participants to a tested intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap, below the 450-participant average among 107 other Quality of Life trials with a reported enrollment target (25% lower).
The record links to 2 conditions, with Quality of Life appearing as the primary indexed condition, and to 2 interventions - of which Strong Together serious game is the first listed.
NCT04813276 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04813276 about?
NCT04813276 is a clinical study titled "Efficacy of a Self-advocacy Serious Game Intervention". 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....
What is the current status of trial NCT04813276?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 336 participants. The study started on 2022-08-22. Estimated completion is 2026-12-31.
What conditions does trial NCT04813276 study?
This clinical trial studies the following conditions: Quality of Life, Self-management.
What interventions are being tested in trial NCT04813276?
The interventions under investigation include: Strong Together serious game (BEHAVIORAL), Enhanced Care as Usual (BEHAVIORAL).
Who is sponsoring clinical trial NCT04813276?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04813276 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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