Ovarian, Fallopian, and Primary Peritoneal Cancer
Conditions
Brief summary
The purpose of this study is to investigate the effects of a stress reduction program on the quality of life of ovarian cancer patients during primary adjuvant chemotherapy.
Interventions
BEHAVIORALDaily stress reduction program
Subjects will participate in activities of a daily stress reduction program.
OTHERAttention control
Subjects will receive periodic phone calls to review study protocol and will receive stress reduction program materials at the end of the study.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have an initial diagnosis of ovarian, fallopian tube or primary peritoneal cancer who completed primary ovarian cancer surgery or 3 cycles of neoadjuvant chemotherapy with interval cytoreductive surgery (ICS). * Final pathology diagnosis of stage I-IV ovarian, fallopian tube or primary peritoneal cancer with plan to receive primary adjuvant chemotherapy or completion of chemotherapy after ICS. * Receive chemotherapy at the University of Wisconsin-Madison. * Subjects must be at least 18 years of age. * English-speaking * Subjects must be able to use audio media, and read and understand the study manual. * ECOG performance status 0-2. * Subjects must have a phone.
Exclusion criteria
* Subjects participating in a meditation practice more than 1 hour per week prior to surgery and/or chemotherapy administration. * Subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer. * Subjects with diagnosis of Chronic Fatigue Syndrome (CFS). * Subjects unable to use audio media due to auditory dysfunction. * Subjects unable to read written English. * Subjects who are prisoners or incarcerated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 18 weeks (completion of chemotherapy) | Fatigue will be measured using the NIH PROMIS Cancer Fatigue survey instrument |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Natural Killer Cell Activity | 18 weeks (completion of chemotherapy) | Cytotoxicity assays will be conducted to determine if the meditation-based intervention results in an increase in the ability of the NK cells to recognize and lyse cancer targets. |
Countries
United States
Outcome results
None listed