Stress Reduction in Ovarian Cancer

Not Applicable

Completed

• Conditions: Ovarian, Fallopian, and Primary Peritoneal Cancer
• Interventions: Other: Attention control; Behavioral: Daily stress reduction program

• Registration Number: NCT01790789
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Primary Completion: 2016-08-09
• Study Completion: 2016-12-06
• Status Verified: 2018-02
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention control	Attention control	-
Stress reduction program	Daily stress reduction program	-

Primary Outcome Measures

Name	Time	Method
Fatigue	18 weeks (completion of chemotherapy)	Fatigue will be measured using the NIH PROMIS Cancer Fatigue survey instrument

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Wisconsin School of Medicine and Public Health; 🇺🇸 Madison, Wisconsin, United States