Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Living Well: A Web-Based Program for Ovarian Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04533763
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
University of Washington
University of Miami
University of Iowa
Information provided by (Responsible Party):
Susan Lutgendorf, University of Iowa

Brief 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, depressive mood (primary aims), anxiety, and fatigue (secondary aims) across a 12-month period.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Behavioral: Technology-based Mindful Living program Behavioral: Technology-based Healthy Lifestyles program Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Living Well: A Web-Based Program to Improve Quality of Life in Rural and Urban Ovarian Cancer Survivors
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : August 30, 2024


Arm Intervention/treatment
Experimental: Mindful Living (ML)
Mindful Living Intervention A 10-week group-based and web-delivered psychosocial intervention targeting key concerns of ovarian cancer survivors.
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.

Active Comparator: Healthy Lifestyles (HL)
Healthy Lifestyle Intervention A 10-week group-based and web-delivered intervention providing information on health promotion for ovarian 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.




Primary Outcome Measures :
  1. Change in HRQOL from baseline (T1) to T2 (immediate change: post-intervention). [ Time Frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week 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.

  2. Change in HRQOL from baseline (T1) to 6 months post intervention (T3) (Long-term change) [ Time Frame: Mean change from pre-intervention baseline to 6 months post-baseline (T3) ]
    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.

  3. Change in HRQOL from baseline (T1) to 12 months post intervention (T4) (Long-term change) [ Time Frame: Mean change from pre-intervention baseline to 12 months post-baseline (T4) ]
    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.

  4. Change in Perceived Stress from baseline (T1) to T2 (immediate change: post-intervention). [ Time Frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week 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.

  5. Change in Perceived Stress from baseline (T1) to 6 months post intervention (T3) (Long-term change) [ Time Frame: Mean change from pre-intervention baseline to 6 months post-baseline (T3) ]
    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.

  6. Change in Perceived Stress from baseline (T1) to 12 months post intervention (T4) (Long-term change) [ Time Frame: Mean change from pre-intervention baseline to 12 months post-baseline (T4) ]
    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.

  7. Change in CESD (depressive mood) from baseline (T1) to T2 (immediate change: post-intervention). [ Time Frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention) ]
    Depressive Mood will be measured by the Center for Epidemiological Studies Depression (CES-D) scale. Higher scores indicate higher levels of depressive mood.

  8. Change in CESD (depressive mood) from baseline (T1) to 6 months post intervention (T3) [ Time Frame: Mean change from pre-intervention baseline to 6 months post-baseline (T3) ]
    Depressive Mood will be measured by the Center for Epidemiological Studies Depression (CES-D) scale. Higher scores indicate higher levels of depressive mood.

  9. Change in CESD (depressive mood) from baseline (T1) to 12 months post intervention (T4) (Long-term change) [ Time Frame: Mean change from pre-intervention baseline to 12 months post-baseline (T4) ]
    Depressive Mood will be measured by the Center for Epidemiological Studies Depression (CES-D) scale. Higher scores indicate higher levels of depressive mood.


Secondary Outcome Measures :
  1. Change in anxiety from baseline (T1) to 6 months post intervention (T3) [ Time Frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention) ]
    Anxiety will be measured by the Profile of Mood States short form Anxiety subscale. Higher scores indicate greater anxiety.

  2. Change in anxiety from baseline (T1) to 6 months post intervention (T3) [ Time Frame: Mean change from pre-intervention baseline to 6 months post-baseline (T3) ]
    Anxiety will be measured by the Profile of Mood States short form Anxiety subscale. Higher scores indicate greater anxiety.

  3. Change in anxiety from baseline (T1) to 12 months post intervention (T4) (Long-term change) [ Time Frame: Mean change from pre-intervention baseline to 12 months post-baseline (T4) ]
    Anxiety will be measured by the Profile of Mood States short form Anxiety subscale. Higher scores indicate greater anxiety.

  4. Change in fatigue from baseline (T1) to T2 (immediate change: post-intervention). [ Time Frame: Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention) ]
    Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F). Higher scores represent lower levels of fatigue.

  5. Change in fatigue from baseline (T1) to 6 months post intervention (T3) [ Time Frame: Mean change from pre-intervention baseline to 6 months post-baseline (T3) ]
    Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F). Higher scores represent lower levels of fatigue.

  6. Change in fatigue from baseline (T1) to 12 months post intervention (T4) (Long-term change [ Time Frame: Mean change from pre-intervention baseline to 12 months post-baseline (T4) ]
    Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F). Higher scores represent lower levels of fatigue.


Other Outcome Measures:
  1. 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. [ Time Frame: Mean change from pre-intervention baseline to completion of the 10 week intervention (T2), 6 months post-baseline,12 months post-baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women between 18 and 90 years of age with a cytological or histological diagnosis of any stage of epithelial ovarian cancer, peritoneal cancer, fallopian tube cancer or cancer of Mullerian origin consistent with ovarian/fallopian tube/peritoneal origin (not consistent with endometrial cancer)..
  • Survivors who have completed primary chemotherapy within the last 3 years.
  • Women receiving their primary chemotherapy may be eligible following the completion of chemotherapy.
  • Women receiving consolidation or maintenance therapy following primary chemotherapy or following treatment for following treatment for first recurrence are eligible.
  • Survivors must not have had more than one recurrence. Those who have had one recurrence will be eligible if they have completed active therapy for their recurrence.
  • Although most women meeting the above criteria will be in remission, complete clinical remission (normal tumor markers and normal CT scan) is not a requirement for eligibility. Even women with low-level disease after completion of cytotoxic chemotherapy who do not meet the strict definition of remission may have stable disease and may not require additional cytotoxic chemotherapy for a prolonged period of time, particularly if they are on maintenance therapy. If subjects recur during the group they will be allowed to continue to participate, as able, even while taking chemotherapy.
  • Survivors must be fluent in spoken English (6th grade level), which is necessary to participate in the intervention.
  • Survivors must be willing to be randomized and followed for 12 months.
  • Survivors must be able to understand and willing to sign a written informed consent document.
  • Survivors currently involved in the STEPS through Ovarian Cancer program will need to wait until their involvement is completed to participate.
  • Survivors currently involved in a study involving another behavioral intervention or an exercise intervention must wait until the prior study is completed to participate.

Exclusion Criteria:

  • Non-epithelial ovarian cancer, ovarian tumors or low malignant potential ("borderline"), cancers originating from other organs.
  • History of prior inpatient psychiatric treatment for severe mental illness (e.g. psychosis) or current psychosis, history of or current bipolar disorder or schizophrenia, current major depression (CESD ≥ 24), dementia, history of organic mental disorder (e.g., dementia) or substance use disorder in the last 2 years or current substance dependence
  • Patients who are currently depressed as indicated by a CES-D Score ≥ 24
  • History of depression is not excluded as long as the patient is not currently depressed (see #6).
  • Women who are younger than 18 years of age or older than 90 years of age.
  • Unable to meet study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533763


Contacts
Layout table for location contacts
Contact: Sharaf Zia, MA 319-467-9780 sharaf-zia@uiowa.edu
Contact: Debra J O'Connell-Moore, MBA 319-356-1693 debra-oconnell-moore@uiowa.edu

Locations
Layout table for location information
United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33146
Contact: Frank J Penedo, PhD    305-243-1391    frank.penedo@miami.edu   
Contact: Matthew Schlumbrecht, MD    305-243-5463    mschlumbrecht@miami.edu   
United States, Iowa
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Sharif Zia, MA    319-467-9780    sharaf-zia@uiowa.edu   
Contact: Debra J O'Connell-Moore, MBA    319-356-1693    debra-oconnell-moore@uiowa.edu   
Principal Investigator: Susan Lutgendorf, PhD         
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Kathryn P Pennington, MD    206-543-3669    adminonc@uw.edu   
Sponsors and Collaborators
Susan Lutgendorf
University of Washington
University of Miami
University of Iowa
Investigators
Layout table for investigator information
Principal Investigator: Susan K Lutgendorf, PhD University of Iowa
Layout table for additonal information
Responsible Party: Susan Lutgendorf, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT04533763    
Other Study ID Numbers: 201911073
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan Lutgendorf, University of Iowa:
ovarian cancer
behavioral
mindfulness
lifestyle
CBT
health promotion
telemedicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type