Stress Reduction in Ovarian Cancer

NCT01790789 | Completed

• 5 other identifiers: 2013-0027OS12706A532800SMPH\OBSTET & GYNECOL\OB-GYNNCI-2013-01401
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian, Fallopian, and Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Fatigue

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

  18 weeks (completion of chemotherapy)

Secondary Outcomes (1)

• Natural Killer Cell Activity

  18 weeks (completion of chemotherapy)

Study Arms (2)

Stress reduction program

EXPERIMENTAL

Behavioral: Daily stress reduction program

Attention control

OTHER

Other: Attention control

Interventions

Daily stress reduction program BEHAVIORAL

Subjects will participate in activities of a daily stress reduction program.

Stress reduction program

Attention control OTHER

Subjects will receive periodic phone calls to review study protocol and will receive stress reduction program materials at the end of the study.

Attention control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

Study Officials

• Stephen Rose, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 13, 2013
• Study Start: February 1, 2013
• Primary Completion: August 9, 2016
• Study Completion: December 6, 2016
• Last Updated: November 19, 2019

Record last verified: 2018-02

Locations

US (1)