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Stress Reduction During Primary Adjuvant Chemotherapy for Ovarian Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Ovarian, Fallopian, and Primary Peritoneal Cancer

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Trial Information

Stress Reduction During Primary Adjuvant Chemotherapy for Ovarian Cancer


Inclusion Criteria:



- Subjects must have an initial diagnosis of ovarian, fallopian tube or primary
peritoneal cancer who completed primary surgery.

- Final pathology diagnosis of stage I-IV ovarian, fallopian tube or primary peritoneal
cancer with plan to receive primary adjuvant chemotherapy.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Outcome Measure:

Fatigue

Outcome Description:

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

Outcome Time Frame:

18 weeks (completion of chemotherapy)

Safety Issue:

No

Principal Investigator

Stephen Rose, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

2013-0027

NCT ID:

NCT01790789

Start Date:

February 2013

Completion Date:

June 2015

Related Keywords:

  • Ovarian, Fallopian, and Primary Peritoneal Cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

University of Wisconsin School of Medicine and Public Health Madison, Wisconsin  53792-5666