Stress Reduction in Ovarian Cancer

NCT ID: NCT01790789

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-12-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Stress reduction program

Group Type: EXPERIMENTAL

Daily stress reduction program

Intervention Type: BEHAVIORAL

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

Attention control

Group Type: OTHER

Attention control

Intervention Type: OTHER

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

Interventions

Daily stress reduction program

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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 0-2.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Rose, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Countries

United States

Related Links

https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

OS12706

Identifier Type: OTHER

Identifier Source: secondary_id

2013-0027

Identifier Type: OTHER

Identifier Source: secondary_id

A532800

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\OBSTET & GYNECOL\OB-GYN

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2013-01401

Identifier Type: REGISTRY

Identifier Source: secondary_id

2013-0027

Identifier Type: -

Identifier Source: org_study_id