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CompletedNCT01790789Updated Nov 19, 2019

Stress Reduction in Ovarian Cancer

An interventional study of Daily stress reduction program and Attention control in Ovarian, Fallopian, and Primary Peritoneal Cancer, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Ovarian, Fallopian, and Primary Peritoneal Cancer
03

In context

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Stress reduction program

    Behavioral: Daily stress reduction program

  • Other
    Attention control

    Other: Attention control

Interventions

  • BehavioralDaily stress reduction program

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

  • OtherAttention control

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

06

What researchers measure

Primary outcomes

  1. Fatigue

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

    Time frame: 18 weeks (completion of chemotherapy)

Secondary outcomes

  1. 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.

    Time frame: 18 weeks (completion of chemotherapy)

07

Study locations

1 site
  • University of Wisconsin School of Medicine and Public Health
    Madison, Wisconsin 53792, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01790789
Lead sponsor
University of Wisconsin, Madison
Responsible party
Sponsor
First posted
Feb 13, 2013
Start date
Feb 2013
Primary completion
Aug 9, 2016
Completion
Dec 6, 2016
Last update
Nov 19, 2019

Study contacts

Stephen Rose, MD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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