Living Well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-06-22 DOI:10.1016/j.cct.2024.107612

Kathryn P. Pennington , Matthew Schlumbrecht , Bonnie A. McGregor , Michael J. Goodheart , Leslie Heron , Bridget Zimmerman , Rachel Telles , Sharaf Zia , Frank J. Penedo , Susan K. Lutgendorf

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Abstract

Background

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.

Methods

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.

Conclusion

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 registration clinicaltrials.gov Identifier: NCT04533763

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好好生活：改善农村和城市卵巢癌幸存者生活质量的网络计划协议。

背景：卵巢癌（OC）幸存者通常会出现慢性症状，包括焦虑、抑郁、睡眠障碍、疲劳、身体症状、健康相关生活质量（HRQOL）差以及预后普遍较差。此外，社会隔离、压力和抑郁等因素与促进肿瘤进展和降低生存率的关键生物过程有关。我们需要可及的社会心理干预措施来改善患者的 HRQOL 和临床预后。这种需求在农村地区尤为突出，因为那里的幸存者可能较难获得以诊所为基础的支持系统：方法："美好生活研究"（Living Well Study）是一项分组随机II期多站点临床试验，旨在评估基于小组、网络提供的社会心理干预（"心智生活"）与健康促进积极对照（"健康生活方式"）在提高256名结肠癌幸存者的HRQOL、减少感知压力（主要结果）、抑郁情绪、焦虑和疲劳（次要结果）方面的疗效：目前，针对卵巢癌幸存者主要关注问题的、易于获得的社会心理干预措施尚未得到满足。正念生活 "干预措施有可能大大提高 OC 幸存者的 HRQOL 并减少其痛苦。试验注册clinicaltrials.gov Identifier：NCT04533763。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.