Stress Reduction in Ovarian Cancer

Stress Reduction During Primary Adjuvant Chemotherapy for Ovarian Cancer

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.

Study Overview

• Status: Completed
• Conditions: Ovarian, Fallopian, and Primary Peritoneal Cancer
• Intervention / Treatment: Behavioral: Daily stress reduction program; Other: Attention control

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stress reduction program	Behavioral: Daily stress reduction program; Subjects will participate in activities of a daily stress reduction program.
OTHER: Attention control	Other: Attention control; Subjects will receive periodic phone calls to review study protocol and will receive stress reduction program materials at the end of the study.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Stephen Rose, MD, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2013
• Primary Completion (ACTUAL): August 9, 2016
• Study Completion (ACTUAL): December 6, 2016

Study Registration Dates

• First Submitted: February 8, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (ESTIMATE): February 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2013-0027 (OTHER: Institutional Review Board); SMPH\OBSTET & GYNECOL\OB-GYN (Other Identifier: UW Madison); A532800 (Other Identifier: UW Madison); OS12706 (OTHER: University of Wisconsin Carbone Cancer Center); NCI-2013-01401 (REGISTRY: NCI Trial ID)