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Testing the effects of the Strong Together self-advocacy serious game among women with advanced cancer: Protocol for the STRONG randomized clinical trial.


ABSTRACT:

Background

Women with advanced cancer experience significant barriers to achieving high-quality care and maximizing their physical and emotional health. Our novel serious game, Strong Together, aims to teach women with advanced cancer self-advocacy skills needed to improve their symptom burden, quality of life, and patient-centered care.

Methods

This is a single-center, multi-site randomized clinical trial of the Strong Together intervention among 336 women within three months of an advanced breast or gynecologic cancer diagnosis. Randomization occurs to the 3-month Strong Together serious game or enhanced care as usual group. The aims are to: (1) evaluate the effects of the intervention on patient self-advocacy (primary outcome); (2) evaluate the effects of the intervention on quality of life, symptom burden, and patient-centered care (secondary outcomes); and (3) evaluate the behavioral and game mechanisms that influence the efficacy of the intervention.

Eligibility criteria

female, age ≥ 18 years; diagnosis of advanced breast or gynecologic cancer within the past 3 months; Eastern Cooperative Oncology Group score of 0-2; English literacy; and ≥ 6-month life expectancy. Patient-reported outcome measures are collected at baseline, 3-months, and 6-months.

Conclusion

This protocol is the first large-scale intervention aimed at promoting self-advocacy in women with advanced cancer. Understanding the ability of serious games to impact patient outcomes provides critical information for researchers, clinicians, and stakeholders aiming to improve patient-centered care.

Trial registration

NCT04813276.

SUBMITTER: Thomas TH 

PROVIDER: S-EPMC9839496 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Testing the effects of the Strong Together self-advocacy serious game among women with advanced cancer: Protocol for the STRONG randomized clinical trial.

Thomas Teresa H TH   Bender Catherine C   Rosenzweig Margaret M   Taylor Sarah S   Sereika Susan M SM   Babichenko Dmitriy D   You Kai-Lin KL   Terry Martha Ann MA   Sabik Lindsay M LM   Schenker Yael Y  

Contemporary clinical trials 20221113


<h4>Background</h4>Women with advanced cancer experience significant barriers to achieving high-quality care and maximizing their physical and emotional health. Our novel serious game, Strong Together, aims to teach women with advanced cancer self-advocacy skills needed to improve their symptom burden, quality of life, and patient-centered care.<h4>Methods</h4>This is a single-center, multi-site randomized clinical trial of the Strong Together intervention among 336 women within three months of  ...[more]

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