Mindful Living, a Web Based Program to Improve Quality of Life in Ovarian, Fallopian Tube, and Primary Peritoneal Cancer Survivors
This phase II trial compares the effects of a stress management and coping program (Mindful Living) with a program promoting healthy lifestyles (Healthy Lifestyles) on quality of life, distress, and well-being in patients with ovarian, fallopian tube, or primary peritoneal cancer. Group-based and web-delivered interventions may help increase connectedness and decrease isolation among ovarian, fallopian tube, and primary peritoneal cancer survivors. The purpose of this trial is to provide information and effective tools for ovarian, fallopian tube, and primary peritoneal cancer survivors to improve quality of life and well-being.
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 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 computed tomography [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
- Ability to understand and the willingness to sign a written informed consent document
- Survivors receiving active treatment for another cancer may be eligible when their treatment is completed
Exclusion Criteria
- TEMPORARY: Survivors involved in steps through ovarian cancer (OC) must wait until they have completed that program to participate
- TEMPORARY: Survivors currently involved in a study involving another behavioral intervention or an exercise intervention must wait until the prior study is over to participate. (In cases 1 and 2, the temporary exclusion will end once survivors have completed their Steps through OC or behavioral intervention or exercise intervention. Study team will note down the date when Steps through OC or the behavioral intervention will end. At this point, the study team will recontact survivors and consent them to the study if they wish to participate.)
- TEMPORARY: Survivors who score greater than or equal to 24 on the Center for Epidemiologic Studies Depression Scale (CESD) can be rescreened when their depressive symptoms resolve. (In case 3, temporary exclusion will end when a survivor feels that their depressive symptoms have resolved, at which point they will retake the online screening on their own. If survivor's score on the CES-D of the online screening is less than 24 on rescreening, the study team will approach them to be consented if they wish to participate.)
- 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 (CESD >= 24), dementia, history of substance use disorder in the last 2 years or current substance dependence, or organic mental disorder (e.g., dementia)
- Unable to meet study requirements
- Currently receiving primary chemotherapy
- History of depression is not excluded as long as the survivor is not currently depressed
- Survivors who are currently depressed as indicated by a CES-D Score >= 24
Additional locations may be listed on ClinicalTrials.gov for NCT04533763.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine the efficacy of a group-based and web-delivered psychosocial intervention for ovarian cancer survivors compared to a health promotion attention-matched condition in increasing health-related quality of life (HRQOL) and decreasing perceived stress, depressive mood, anxiety, and fatigue across a 12-month period.
II. To determine whether the skills provided in Mindful Living (i.e., cognitive reframing, relaxation, mindfulness- and acceptance-based skills) mediate the effects of Mindful Living on these outcome measures.
EXPLORATORY OBJECTIVES:
I. To determine whether the effect of the intervention varies across several factors such as rural versus (vs.) urban residence, recurrence status, age, disease stage, or time since diagnosis.
II. To characterize effects of the Living WELL intervention in ovarian cancer survivors on inflammatory biology in peripheral blood cells as assessed with dried blood spot technology.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend Mindful Living group sessions over 1.5-2 hours via secure web-video conferencing weekly for 11 weeks, and then booster sessions over 1-1.5 hours at 19-20 and 39-40 weeks. Mindful Living sessions focus on topics such as coping with ovarian cancer, stress management, maximizing support from friends and family, living with an ovarian cancer diagnosis, relaxation and meditation techniques, spirituality, and imagery.
ARM II: Patients attend Healthy Lifestyles group sessions over 1.5-2 hours via secure web-video conferencing weekly for 11 weeks, and then booster sessions over 1-1.5 hours at 19-20 and 39-40 weeks. Healthy Lifestyles sessions focus on topics such as exercise, sleep, nutrition, cognitive function, stress management, and survivorship.
After completion of study, patients are followed up at 3, 6, and 12 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Iowa/Holden Comprehensive Cancer Center
Principal InvestigatorSusan K Lutgendorf
- Primary ID201911073
- Secondary IDsNCI-2020-08089
- ClinicalTrials.gov IDNCT04533763