Acupressure for Cancer-fatigue in Ovarian Cancer Survivor (AcuOva) Study: A community-based clinical trial study protocol examining the impact of self-acupressure on persistent cancer-related fatigue in ovarian cancer survivors.

Suzanna Maria Zick, Grant Kruger, Steven Harte, Ananda Sen, Richard Edmund Harris, Celeste Leigh Pearce

Journal: Contemporary clinical trials 2021;107():106477

PMID: 34119716

Full Text on Elsevier Science View on PubMed

Abstract

Background Persistent cancer-related fatigue is one of the most common and burdensome symptoms experienced by ovarian cancer survivors. Despite the high burden of fatigue in ovarian cancer survivors, there are few available treatments. Previous research has shown self-acupressure to be a safe method for improving persistent fatigue, sleep, and quality of life among fatigued breast cancer survivors, yet there are no studies examining self-acupressure for fatigue in ovarian cancer survivors. Methods A three group parallel, randomized controlled trial will be conducted to evaluate the efficacy of self-acupressure taught and delivered via a patient-designed, custom-built mobile app ("MeTime") and accompanying hand-held device ("AcuWand") to help guide correct pressure application. A sample of 165 ovarian cancer survivors, who have completed primary cancer treatment will be recruited from tumor registries in Michigan and Los Angeles. Participants will be mailed a tablet preloaded with the app and a device, and all visits will be conducted remotely. Participants will be randomized to 6-weeks of daily self-acupressure via the app and device, or a sham app and device, or no care group. Self-report measures will be completed at baseline, 6-weeks (post-intervention), 3-, and 6-months. Primary outcome is the Brief Fatigue Inventory; secondary outcomes are sleep, quality of life, and symptoms commonly associated with persistent fatigue. Discussion An app based self-acupressure treatment may be an easily-accessible and inexpensive treatment to reduce fatigue in ovarian cancer survivors. The results of the study will provide information on the possible benefits of app-based self-acupressure for fatigue in ovarian cancer survivors. Trial registration: This study is registered at ClinicalTrials.gov Identifier: NCT03763838, date registered on December 4, 2018.

Address: Department of Family Medicine, University of Michigan, 24 Frank Lloyd Wright Drive, Ann Arbor, MI 48105, USA; Department of Nutritional Sciences, University of Michigan, 1415 Washington Heights, Ann Arbor, MI 48109, USA. Electronic address: [email protected].; Department of Mechanical Engineering, University of Michigan, 1043 H H Dow Bldg, Ann Arbor, MI 48109-2136, USA; Department of Anesthesiology, University of Michigan, 1043 H H Dow Bldg, Ann Arbor, MI 48109-2136, USA. Electronic address: [email protected].; Department of Anesthesiology, University of Michigan, Domino's Farms/Lobby M, Ann Arbor, MI 48106, USA; Department of Rheumatology, University of Michigan, Domino's Farms/Lobby M, Ann Arbor, MI 48106, USA. Electronic address: [email protected].; Department of Family Medicine, University of Michigan, 1018 Fuller Street, Ann Arbor, MI 48104-1213, USA; Department of Biostatistics, University of Michigan, 1018 Fuller Street, Ann Arbor, MI 48104-1213, USA. Electronic address: [email protected].; Department of Anesthesiology, University of Michigan, 24 Frank Lloyd Wright Drive, Ann Arbor, MI 48105, USA. Electronic address: [email protected].; Department of Epidemiology, University of Michigan, 1415 Washington Heights, Ann Arbor, MI 48109-2029, USA. Electronic address: [email protected].

DOI: 10.1016/j.cct.2021.106477

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MeSH Terms: Acupressure, Breast Neoplasms, Cancer Survivors, Fatigue, Female, Humans, Quality of Life, Randomized Controlled Trials as Topic, Treatment Outcome