Trials / Active Not Recruiting
Active Not RecruitingNCT04533763
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
Living WELL: A Web-Based Program to Improve Quality of Life in Rural and Urban Ovarian Cancer Survivors
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 326 (actual)
- Sponsor
- Susan Lutgendorf · Academic / Other
- Sex
- Female
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Technology-based Mindful Living program | 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. |
| BEHAVIORAL | Technology-based Healthy Lifestyles program | 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. |
Timeline
- Start date
- 2020-09-30
- Primary completion
- 2026-01-07
- Completion
- 2026-04-30
- First posted
- 2020-09-01
- Last updated
- 2026-03-24
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04533763. Inclusion in this directory is not an endorsement.