Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Technology-based Healthy Lifestyles program | Behavioral | — | UNRESOLVED |
| Technology-based Mindful Living program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mindful Living (ML)
- description
- Mindful Living Intervention A 10-week group-based and web-delivered psychosocial intervention targeting key concerns of ovarian cancer survivors.
- interventionNames
- Behavioral: Technology-based Mindful Living program
- type
- ACTIVE_COMPARATOR
- label
- Healthy Lifestyles (HL)
- description
- Healthy Lifestyle Intervention A 10-week group-based and web-delivered intervention providing information on health promotion for ovarian cancer survivors.
- interventionNames
- Behavioral: Technology-based Healthy Lifestyles program
Primary outcomes (4)
- measure
- Change in HRQOL from baseline (T1) to T2 (immediate change: post-intervention).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria:
* 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.
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).References
Publications (1)
- DERIVEDPennington 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