Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
N/A
Funding Agency/Sponsor
Externally Peer-Reviewed
Disease
Population Sciences
Enrollment Eligibility
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).