Journal article
Living well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors
Contemporary clinical trials, Vol.144, 107612
09/2024
DOI: 10.1016/j.cct.2024.107612
PMCID: PMC11323255
PMID: 38914309
Abstract
Ovarian cancer (OC) survivors commonly experience chronic symptoms including anxiety, depression, sleep disturbances, fatigue, physical symptoms, poor health-related quality of life (HRQOL), and a generally poor prognosis. Additionally, factors such as social isolation, stress, and depression are associated with key biological processes promoting tumor progression and poorer survival. Accessible psychosocial interventions to improve HRQOL and clinical outcomes are needed. This need is particularly true in rural settings where survivors may have less access to clinic-based support systems.
The Living Well Study, a cluster-randomized Phase II multi-site clinical trial, is designed to evaluate the efficacy of a group-based, web-delivered psychosocial intervention (Mindful Living) verses a Health Promotion active control (Healthy Lifestyles) in increasing HRQOL and decreasing perceived stress (primary outcomes), depressive mood, anxiety, and fatigue (secondary outcomes) for 256 OC survivors who are <5 years post-primary therapy. Mindful Living targets key concerns of OC survivors and teaches stress reduction skills and coping strategies utilizing cognitive behavioral, mindfulness, and acceptance and commitment therapies. Healthy Lifestyles provides lifestyle information including exercise, nutrition, sleep, and other survivorship topics. Interventions consist of 11 consecutive weekly group sessions lasting 1.5–2 h led by trained facilitators and two booster sessions. Participants complete psychosocial questionnaires at baseline, post-intervention, at 6-months, and at 12-months. A subset completes bloodspots for analysis of inflammatory biology.
Easily accessible psychosocial interventions addressing key concerns of OC survivors are an unmet need. The Mindful Living intervention has the potential to substantially enhance HRQOL and decrease distress in OC survivors.
Trial registrationclinicaltrials.gov Identifier: NCT04533763
Details
- Title: Subtitle
- Living well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors
- Creators
- Kathryn P. Pennington - Alaska Women's Cancer CareMatthew Schlumbrecht - Sylvester Comprehensive Cancer CenterBonnie A. McGregor - Integrative Medicine InstituteMichael J. Goodheart - University of IowaLeslie Heron - Fred Hutch Cancer CenterBridget Zimmerman - University of Iowa, BiostatisticsRachel Telles - University of IowaSharaf Zia - University of IowaFrank J. Penedo - Sylvester Comprehensive Cancer CenterSusan K. Lutgendorf - University of Iowa
- Resource Type
- Journal article
- Publication Details
- Contemporary clinical trials, Vol.144, 107612
- DOI
- 10.1016/j.cct.2024.107612
- PMID
- 38914309
- PMCID
- PMC11323255
- NLM abbreviation
- Contemp Clin Trials
- ISSN
- 1551-7144
- eISSN
- 1559-2030
- Publisher
- Elsevier Inc
- Language
- English
- Electronic publication date
- 06/22/2024
- Date published
- 09/2024
- Academic Unit
- Psychological and Brain Sciences; Iowa Neuroscience Institute; Biostatistics; Obstetrics and Gynecology; Writers’ Workshop; Urology
- Record Identifier
- 9984649056602771
Metrics
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