Online program helps ovarian cancer survivors feel better
NCT ID NCT04533763
First seen Jun 24, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study tested a web-based program to improve quality of life and reduce stress in ovarian cancer survivors. 326 women participated, comparing a mindfulness program to a healthy lifestyle program. The goal was to see if the online programs could help with stress, anxiety, mood, and fatigue over 12 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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341 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
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University of Miami
Miami, Florida, 33146, United States
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University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
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University of Washington Cancer Consortium
Seattle, Washington, 98195, United States
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Other studies related to the condition(s) this trial covers.
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