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

Primary Purpose

Ovarian Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Technology-based Mindful Living program
Technology-based Healthy Lifestyles program
Sponsored by
Susan Lutgendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ovarian Cancer focused on measuring ovarian cancer, behavioral, mindfulness, lifestyle, CBT, health promotion, telemedicine

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Survivors 18 years or older 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). Individuals diagnosed with synchronous ovarian and endometrial cancer primaries may be included if the initial endometrial cancer was stage I. Survivors who have completed primary treatment (surgery and chemotherapy or chemotherapy alone for a new diagnosis ovarian/peritoneal/fallopian tube cancer within the last 5 years). Date of completion of primary treatment is defined as within approximately 60 days after the last chemotherapy infusion. Maintenance therapy infusions do not count indetermining date of completion of primary therapy. Women who were not recommended to receive adjuvant chemotherapy (for example, in the case of certain stage IA/IB cancers) are eligible after surgery alone. Women receiving consolidation or maintenance therapy following primary chemotherapy or 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 receiving active treatment for another cancer may be eligible when their treatment is completed.

Temporary Exclusion:

  • Survivors involved in Steps through OC must wait until they have completed that program to participate.
  • Survivors currently involved in a study involving another behavioral intervention or an exercise intervention must wait until the prior study is over to participate.
  • Survivors who score greater than or equal to 24 on the CESD can be rescreened when their depressive symptoms resolve.

Exclusion Criteria:

  • Non-epithelial ovarian cancer, ovarian tumors of low malignant potential ("borderline"), cancers originating from other organs. Survivor who have a history of a prior cancer besides their ovarian cancer will be considered eligible as long as they are not in active therapy for said other prior cancer.
  • History of prior inpatient psychiatric treatment for severe mental illness (e.g. psychosis) or current psychosis, history of bipolar disorder or schizophrenia in the last 2 years or current bipolar disorder or schizophrenia, current major depression, history of substance use disorder in the last 2 years or current substance dependence, organic mental disorder (e.g., dementia), or substance use disorder in the last 2 years.
  • Survivors who are younger than 18 or older than 90 years of age
  • Unable to meet study requirements
  • Currently receiving primary chemotherapy.
  • History of depression is not excluded as long as the patient is not currently depressed
  • Survivors who are currently depressed as indicated by a CES-D Score ≥ 24 (can be rescreened once the depressive symptoms resolve).

Sites / Locations

  • University of MiamiRecruiting
  • University of Iowa Hospitals & ClinicsRecruiting
  • Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindful Living (ML)

Healthy Lifestyles (HL)

Arm Description

Mindful Living Intervention A 10-week group-based and web-delivered psychosocial intervention targeting key concerns of ovarian cancer survivors.

Healthy Lifestyle Intervention A 10-week group-based and web-delivered intervention providing information on health promotion for ovarian cancer survivors.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 18, 2020
Last Updated
August 9, 2023
Sponsor
Susan Lutgendorf
Collaborators
University of Washington, University of Miami, University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT04533763
Brief Title
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
Official Title
Living WELL: A Web-Based Program to Improve Quality of Life in Rural and Urban Ovarian Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susan Lutgendorf
Collaborators
University of Washington, University of Miami, University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian cancer, behavioral, mindfulness, lifestyle, CBT, health promotion, telemedicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindful Living (ML)
Arm Type
Experimental
Arm Description
Mindful Living Intervention A 10-week group-based and web-delivered psychosocial intervention targeting key concerns of ovarian cancer survivors.
Arm Title
Healthy Lifestyles (HL)
Arm Type
Active Comparator
Arm Description
Healthy Lifestyle Intervention A 10-week group-based and web-delivered intervention providing information on health promotion for ovarian cancer survivors.
Intervention Type
Behavioral
Intervention Name(s)
Technology-based Mindful Living program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Technology-based Healthy Lifestyles program
Intervention Description
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 Measure Information:
Title
Change in HRQOL from baseline (T1) to T2 (immediate change: post-intervention).
Description
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)
Title
Change in HRQOL from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Description
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)
Title
Change in Perceived Stress from baseline (T1) to T2 (immediate change: post-intervention).
Description
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)
Title
Change in Perceived Stress from baseline (T1) across a 12-month interval post randomization: ((T4) Long-term change)
Description
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)
Secondary Outcome Measure Information:
Title
Change in anxiety from baseline (T1) to T2 (immediate change: post-intervention)
Description
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)
Title
Change in anxiety from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Description
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)
Title
Change in fatigue from baseline (T1) to T2 (immediate change: post-intervention).
Description
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)
Title
Change in fatigue from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Description
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)
Title
Change in CESD (depressive mood) from baseline (T1) to T2 (immediate change: post-intervention).
Description
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)
Title
Change in CESD from baseline (T1) across a 12-month interval post randomization :((T4) Long-term change)
Description
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)
Other Pre-specified Outcome Measures:
Title
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.
Description
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.
Time Frame
Mean change from pre-intervention baseline to completion of the 10 week intervention (T2), 6 months post-baseline,12 months post-baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Survivors 18 years or older 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). Individuals diagnosed with synchronous ovarian and endometrial cancer primaries may be included if the initial endometrial cancer was stage I. Survivors who have completed primary treatment (surgery and chemotherapy or chemotherapy alone for a new diagnosis ovarian/peritoneal/fallopian tube cancer within the last 5 years). Date of completion of primary treatment is defined as within approximately 60 days after the last chemotherapy infusion. Maintenance therapy infusions do not count indetermining date of completion of primary therapy. Women who were not recommended to receive adjuvant chemotherapy (for example, in the case of certain stage IA/IB cancers) are eligible after surgery alone. Women receiving consolidation or maintenance therapy following primary chemotherapy or 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 receiving active treatment for another cancer may be eligible when their treatment is completed. Temporary Exclusion: Survivors involved in Steps through OC must wait until they have completed that program to participate. Survivors currently involved in a study involving another behavioral intervention or an exercise intervention must wait until the prior study is over to participate. Survivors who score greater than or equal to 24 on the CESD can be rescreened when their depressive symptoms resolve. Exclusion Criteria: Non-epithelial ovarian cancer, ovarian tumors of low malignant potential ("borderline"), cancers originating from other organs. Survivor who have a history of a prior cancer besides their ovarian cancer will be considered eligible as long as they are not in active therapy for said other prior cancer. History of prior inpatient psychiatric treatment for severe mental illness (e.g. psychosis) or current psychosis, history of bipolar disorder or schizophrenia in the last 2 years or current bipolar disorder or schizophrenia, current major depression, history of substance use disorder in the last 2 years or current substance dependence, organic mental disorder (e.g., dementia), or substance use disorder in the last 2 years. Survivors who are younger than 18 or older than 90 years of age Unable to meet study requirements Currently receiving primary chemotherapy. History of depression is not excluded as long as the patient is not currently depressed Survivors who are currently depressed as indicated by a CES-D Score ≥ 24 (can be rescreened once the depressive symptoms resolve).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharaf Zia, MA
Phone
319-467-9780
Email
sharaf-zia@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Debra J O'Connell-Moore, MBA
Phone
319-356-1693
Email
debra-oconnell-moore@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan K Lutgendorf, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Diaz, MS
Phone
305-243-5825
Email
LDiaz5@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Frank J Penedo, PhD
Phone
305-243-1391
Email
frank.penedo@miami.edu
First Name & Middle Initial & Last Name & Degree
Frank J Penedo, PhD
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharif Zia, MA
Phone
319-467-9780
Email
sharaf-zia@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Debra J O'Connell-Moore, MBA
Phone
319-356-1693
Email
debra-oconnell-moore@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Susan Lutgendorf, PhD
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emiko Oshima
Phone
206-616-2532
Email
eoshima@uw.edu
First Name & Middle Initial & Last Name & Degree
Kathryn Pennington, MD
Phone
206-543-3669
Email
adminonc@uw.edu
First Name & Middle Initial & Last Name & Degree
Kathryn Pennington, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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