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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA246540-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| University of Miami | OTHER |
| University of Iowa | OTHER |
| National Cancer Institute (NCI) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindful Living (ML) | Experimental | Mindful Living Intervention A 10-week group-based and web-delivered psychosocial intervention targeting key concerns of ovarian cancer survivors. |
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| Healthy Lifestyles (HL) | Active Comparator | Healthy Lifestyle Intervention A 10-week group-based and web-delivered intervention providing information on health promotion for ovarian cancer survivors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology-based Mindful Living program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 6 months to 12 months post-baseline (T4) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety from baseline (T1) to T2 (immediate change: post-intervention) | Anxiety will be measured by the Profile of Mood States short form Anxiety subscale. Higher scores indicate greater anxiety. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Statistical correlations between change in stress management skills, mindfulness, cognitive coping, acceptance, and relaxation frequency and changes in HRQOL, Depressive Mood, Perceived Stress, anxiety and fatigue. | Stress management skills will be assessed using the Measure of Current States (MOS), Mindfulness skills will be assessed using the Freiburg Mindfulness Inventory, Cognitive Coping Skills will be assessed using the Brief COPE, Acceptance Skills will be assessed using the Acceptance and Action Questionnaire (AAQII), Relaxation frequency will be assessed by a web-based counter documenting frequency of relaxation practice. |
Inclusion Criteria:
Temporary Exclusion:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan K Lutgendorf, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33146 | United States | ||
| University of Iowa Hospitals & Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38914309 | Derived | Pennington KP, Schlumbrecht M, McGregor BA, Goodheart MJ, Heron L, Zimmerman B, Telles R, Zia S, Penedo FJ, Lutgendorf SK. Living Well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors. Contemp Clin Trials. 2024 Sep;144:107612. doi: 10.1016/j.cct.2024.107612. Epub 2024 Jun 22. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2024 | Oct 24, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 10, 2020 | Feb 2, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| NIH |
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| Technology-based Healthy Lifestyles program | Behavioral | 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. |
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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. |
| 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. | 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. | 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. | 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. | 6 months to 12 months post-baseline (T4) |
| Mean change from pre-intervention baseline to completion of the 10 week intervention (T2), 6 months post-baseline,12 months post-baseline |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University of Washington Cancer Consortium | Seattle | Washington | 98195 | United States |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |