Stress Reduction in Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Stress Reduction During Primary Adjuvant Chemotherapy for Ovarian Cancer

Conditions
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Ovarian, Fallopian, and Primary Peritoneal Cancer

Intervention / Treatment
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* Behavioral: Daily stress reduction program
* Other: Attention control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress reduction program<br> | Behavioral: Daily stress reduction program<br>* Subjects will participate in activities of a daily stress reduction program.<br>|
| Other: Attention control<br> | Other: Attention control<br>* Subjects will receive periodic phone calls to review study protocol and will receive stress reduction program materials at the end of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Fatigue will be measured using the NIH PROMIS Cancer Fatigue survey instrument | 18 weeks (completion of chemotherapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural Killer Cell Activity | 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. | 18 weeks (completion of chemotherapy) |