The purpose of this study is to determine the efficacy of a group-based and web-delivered psychosocial intervention for ovarian cancer survivors (Mindful Living \[ML\]) compared to a health promotion condition (Healthy Lifestyles \[HL\]) in increasing health related quality of life (HRQOL) and decreasing perceived stress (primary aim), and decreasing anxiety, depressive mood, and fatigue (secondary aims) across a 12-month period.
Living WELL is a randomized clinical trial examining two different programs for helping ovarian cancer survivors cope and improve the quality of their lives following treatment. The programs include techniques and information to enhance both mental and physical well-being. The study is conducted through an internet video conferencing platform and is open to survivors in all parts of the US. The purpose of this study is to examine the effects of various factors such as emotions, stress management and coping techniques, and health information on quality of life, stress levels, depression, fatigue, and distress in ovarian cancer survivors. Participants are randomized into either a Mindful Living group (targeting stress management skills - e.g., relaxation, coping) or a Healthy Lifestyles group (targeting health promotion strategies - e.g, nutrition, sleep, exercise). Participation in this study includes taking part in an introductory online meeting, 10 consecutive weekly online sessions, and follow-up meetings at approximately 4.5 and 9 months following randomization. Each session will be 1.5-2 hours. Participants will complete surveys online prior to beginning the program, within a week after the 10-week program is completed, and at 6 months and 12 months later.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
326
The program is delivered using web-based group conferencing. During each session, participants are taught new stress management and coping techniques. Each week there is opportunity to apply techniques to real world situations for practice. Participants have a group orientation session, and then meet for 10 weeks. Group sessions last 1.5 - 2 hours. Booster sessions occur approximately 4.5 and 9 months post- randomization. Program includes training in mindfulness, cognitive behavioral stress management, relaxation, imagery, prioritizing meaningful activities, communication, and coping strategies. Content is geared toward concerns of cancer survivors.
The program is delivered using web-based group conferencing. Sessions include content from the National Cancer Institute, American Cancer Society, and health care providers with expertise in oncology. All content is geared to promoting healthy living among ovarian cancer survivors. Participants have a group orientation session, and then meet for 10 weeks, with group sessions lasting 1.5 - 2 hours. Booster sessions occur approximately 4.5 and 9 months post-randomization. Healthy Lifestyle sessions include topics such as nutrition, exercise, sleep, quality of life, survivorship, and cognitive function with content geared toward concerns of cancer survivors.
University of Miami
Miami, Florida, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University of Washington Cancer Consortium
Seattle, Washington, United States
Change in HRQOL from baseline (T1) to T2 (immediate change: post-intervention).
HRQOL will be measured by the Functional Assessment of Cancer Therapy (FACT-O) survey, a health survey designed to assess multiple dimensions of HRQOL. Higher scores indicate better HRQOL.
Time frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in HRQOL from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
HRQOL will be measured by the Functional Assessment of Cancer Therapy (FACT-O) survey, a health survey designed to assess multiple dimensions of HRQOL. Higher scores indicate better HRQOL Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
Time frame: 6 months to 12 months post-baseline (T4)
Change in Perceived Stress from baseline (T1) to T2 (immediate change: post-intervention).
Perceived Stress will be measured by the Perceived Stress Scale (PSS) a scale commonly used to assess subjective levels of stress. Higher scores indicate more stress.
Time frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in Perceived Stress from baseline (T1) across a 12-month interval post randomization: ((T4) Long-term change)
Perceived Stress will be measured by the Perceived Stress Scale (PSS) a scale commonly used to assess subjective levels of stress. Higher scores indicate more stress. Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
Time frame: 6 months to 12 months post-baseline (T4)
Change in anxiety from baseline (T1) to T2 (immediate change: post-intervention)
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Anxiety will be measured by the Profile of Mood States short form Anxiety subscale. Higher scores indicate greater anxiety.
Time frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in anxiety from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Anxiety will be measured by the Profile of Mood States short form Anxiety subscale. Higher scores indicate higher levels of anxiety Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
Time frame: 6 months to 12 months post-baseline (T4)
Change in fatigue from baseline (T1) to T2 (immediate change: post-intervention).
Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F). Higher scores represent lower levels of fatigue.
Time frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in fatigue from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F). Higher scores represent lower levels of fatigue. Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
Time frame: 6 months to 12 months post-baseline (T4)
Change in CESD (depressive mood) from baseline (T1) to T2 (immediate change: post-intervention).
Depressive Mood will be measured by the Center for Epidemiological Studies Depression (CES-D) scale. Higher scores indicate higher levels of depressive mood.
Time frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)
Change in CESD from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Depressive Mood will be measured by the Center for Epidemiological Studies Depression (CES-D) scale. Higher scores indicate higher levels of depressive mood. Linear mixed models for repeated measures will be used to test for efficacy with p values adjusted using Bonferroni methods to account for the two timepoints.
Time frame: 6 months to 12 months post-baseline (T4)