Skip to main content
OpenTrials
Completed

NCT Number: NCT01790789

Stress Reduction in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian, Fallopian, and Primary Peritoneal Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daily stress reduction program

Behavioral

Subjects will participate in activities of a daily 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.

Primary outcomes

  1. Fatigue

    Time frame: 18 weeks (completion of chemotherapy)

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

Secondary outcomes

  1. Natural Killer Cell Activity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Stress Reduction During Primary Adjuvant Chemotherapy for Ovarian Cancer

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 13, 2013
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.