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Randomized Controlled Trial
. 2023 Oct 1;129(19):3034-3043.
doi: 10.1002/cncr.34887. Epub 2023 May 27.

The feasibility, acceptability, and preliminary efficacy of a self-advocacy serious game for women with advanced breast or gynecologic cancer

Affiliations
Randomized Controlled Trial

The feasibility, acceptability, and preliminary efficacy of a self-advocacy serious game for women with advanced breast or gynecologic cancer

Teresa Hagan Thomas et al. Cancer. .

Abstract

Background: Cancer clinicians and systems aim to provide patient-centered care, but not all patients have the self-advocacy skills necessary to ensure their care reflects their needs and priorities. This study examines the feasibility, acceptability, and preliminary efficacy of a self-advocacy serious game (an educational video game) intervention in women with advanced breast or gynecologic cancer.

Methods: Women with recently diagnosed (<3 months) metastatic breast or advanced gynecologic cancer were randomized 2:1 to receive a tablet-based serious game (Strong Together) (n = 52) or enhanced care as usual (n = 26). Feasibility was based on recruitment, retention, data completion, and intervention engagement. Acceptability was assessed via a postintervention questionnaire and exit interview. Preliminary efficacy was assessed on the basis of change scores from baseline to 3 and 6 months in self-advocacy (Female Self-Advocacy in Cancer Survivorship Scale) using intention-to-treat analysis.

Results: Seventy-eight women (55.1% with breast cancer; 44.9% with gynecologic cancer) were enrolled. Feasibility was demonstrated by satisfactory recruitment (69% approach-to-consent rate; 93% enroll-to-randomize rate), retention (90% and 86% at 3 and 6 months, respectively; 85% data completion), and intervention engagement (84% completed ≥75% of the game). Participants endorsed the intervention's (75%) and trial's (87%) acceptability. Participants in the intervention group experienced significant improvements in self-advocacy at 3 and 6 months compared to participants in the control group.

Conclusions: Strong Together is feasible and acceptable among women with advanced breast or gynecologic cancer. This intervention demonstrates promising evidence of clinical efficacy. A future confirmatory trial is warranted to test the efficacy of the intervention for patient and health system outcomes.

Keywords: breast cancer; gynecologic cancer; mobile applications; patient-centered care; self-advocacy; self-management.

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Conflict of interest statement

CONFLICT OF INTEREST STATEMENT

Teresa Hagan Thomas has received grants from the Division of Cancer Prevention, National Cancer Institute. Sarah Taylor has been a consultant for AstraZeneca. Yael Schenker has been a consultant for UpToDate and received grants from the National Institutes of Health. The other authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Consolidated Standards of Reporting Trials diagram. ECOG indicates Eastern Cooperative Oncology Group.
FIGURE 2
FIGURE 2
Change in Female Self-Advocacy in Cancer Survivorship (FSACS) scale scores from baseline to 6 months for the total sample and by type of cancer for the (A) total FSACS scale, (B) informed decision-making subscale, (C) effective communication subscale, and (D) connected strength subscale. ECAU indicates enhanced care as usual.

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