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

Teresa H Thomas; Catherine Bender; Margaret Rosenzweig; Sarah Taylor; Susan M Sereika; Dmitriy Babichenko; Kai-Lin You; Martha Ann Terry; Lindsay M Sabik; Yael Schenker

doi:10.1016/j.cct.2022.107003

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.

Authors

Affiliations

¹ University of Pittsburgh School of Nursing, University of Pittsburgh, 3500 Victoria Street, Pittsburgh 15261, PA, USA; Palliative Research Center (PaRC), University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh 15213, PA, USA. Electronic address: t.thomas@pitt.edu.
² University of Pittsburgh School of Nursing, University of Pittsburgh, 3500 Victoria Street, Pittsburgh 15261, PA, USA. Electronic address: cbe100@pitt.edu.
³ University of Pittsburgh School of Nursing, University of Pittsburgh, 3500 Victoria Street, Pittsburgh 15261, PA, USA; Palliative Research Center (PaRC), University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh 15213, PA, USA; University of Pittsburgh Medical Center Magee-Womens Hospital, 300 Halket Street, Pittsburgh 15213, PA, USA. Electronic address: mros@pitt.edu.
⁴ University of Pittsburgh Medical Center Magee-Womens Hospital, 300 Halket Street, Pittsburgh 15213, PA, USA. Electronic address: taylorse2@upmc.edu.
⁵ University of Pittsburgh School of Nursing, University of Pittsburgh, 3500 Victoria Street, Pittsburgh 15261, PA, USA. Electronic address: ssereika@pitt.edu.
⁶ University of Pittsburgh School of Computing and Information, 135 North Bellefield Avenue, Pittsburgh 15213, PA, USA. Electronic address: Dmitriy.b@pitt.edu.
⁷ University of Pittsburgh School of Nursing, University of Pittsburgh, 3500 Victoria Street, Pittsburgh 15261, PA, USA. Electronic address: kailinyou@pitt.edu.
⁸ University of Pittsburgh School of Public Health, 130 De Soto Street, Pittsburgh 15261, PA, USA. Electronic address: materry@pitt.edu.
⁹ University of Pittsburgh School of Public Health, 130 De Soto Street, Pittsburgh 15261, PA, USA. Electronic address: lsabik@pitt.edu.
¹⁰ Palliative Research Center (PaRC), University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh 15213, PA, USA; University of Pittsburgh School of Medicine, Division of General Internal Medicine, 200 Lothrop Street, Pittsburgh 15213, PA, USA. Electronic address: yas28@pitt.edu.

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.

Keywords: Communication; Decision-making; Health games; Patient self-advocacy; Videogames; Virtual systems.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural

MeSH terms

Adolescent
Adult
Breast Neoplasms* / pathology
Breast Neoplasms* / therapy
Female
Games, Experimental*
Genital Neoplasms, Female* / pathology
Genital Neoplasms, Female* / therapy
Humans
Quality of Life
Randomized Controlled Trials as Topic
Self Care*
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT04813276

Abstract

Publication types

MeSH terms

Associated data

Grants and funding