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

NCT04533763 | Active Not Recruiting DMC

• 2 other identifiers: 2019110735R01CA246540-02
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 4

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

Conditions

Ovarian Cancer

Keywords

ovarian cancer; behavioral; mindfulness; lifestyle; CBT; health promotion; telemedicine

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (6)

• Change in anxiety from baseline (T1) to T2 (immediate change: post-intervention)

  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)

  6 months to 12 months post-baseline (T4)

• Change in fatigue from baseline (T1) to T2 (immediate change: post-intervention).

  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)

  6 months to 12 months post-baseline (T4)

• Change in CESD (depressive mood) from baseline (T1) to T2 (immediate change: post-intervention).

  Mean change from pre-intervention baseline to T2 (after completion of the 10 week intervention)

Other Outcomes (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.

  Mean change from pre-intervention baseline to completion of the 10 week intervention (T2), 6 months post-baseline,12 months post-baseline

Study Arms (2)

Mindful Living (ML)

EXPERIMENTAL

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

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.

Behavioral: Technology-based Healthy Lifestyles program

Interventions

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.

Healthy Lifestyles (HL)

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.

Mindful Living (ML)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Survivors 18 (19 at UNMC since age of Majority is 19 in Nebraska) 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 in determining 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Susan Lutgendorf: lead
• University of Miami: collaborator
• University of Iowa: collaborator
• University of Washington: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (4)

University of Miami

Miami, Florida, 33146, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of Washington Cancer Consortium

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 38914309 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Behavior

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Susan K Lutgendorf, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: September 1, 2020
• Study Start: September 30, 2020
• Primary Completion: January 7, 2026
• Study Completion: April 30, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)