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Clinical Trials/NCT01790789
NCT01790789
Completed
Not Applicable

Stress Reduction During Primary Adjuvant Chemotherapy for Ovarian Cancer

University of Wisconsin, Madison1 site in 1 country41 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian, Fallopian, and Primary Peritoneal Cancer
Sponsor
University of Wisconsin, Madison
Enrollment
41
Locations
1
Primary Endpoint
Fatigue
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
December 6, 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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-
  • 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.

Outcomes

Primary Outcomes

Fatigue

Time Frame: 18 weeks (completion of chemotherapy)

Fatigue will be measured using the NIH PROMIS Cancer Fatigue survey instrument

Secondary Outcomes

  • Natural Killer Cell Activity(18 weeks (completion of chemotherapy))

Study Sites (1)

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