Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer

October 8, 2015 updated by: Barbara Andersen, Ohio State University Comprehensive Cancer Center

A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence

This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To refine the intervention. II. Test the acceptability, feasibility, and clinical appropriateness of the intervention.

III. To provide a preliminary test of its efficacy.

OUTLINE:

Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising mindfulness-based stress reduction (MBSR), an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.

After completion of study treatment, patients are followed up at 28 weeks.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of recurrent breast or gynecologic cancer (any site) with any disease-free interval; second primary cancers do not meet this criterion
  • English speaking
  • Able and willing to give informed consent

  • To be considered for the blood and saliva collection, women must fulfill the following secondary criteria:

    • Diagnosis of recurrent breast or ovarian cancer with any disease-free interval

Exclusion Criteria:

  • Residence > 70 miles from research site
  • Subnormal intellectual potential (diagnosis of mental retardation)
  • Progressive neurological or chronic, progressive, debilitating condition (e.g., dementia)
  • Non-ambulatory
  • Life expectancy less than 160 days, per the treating oncologist
  • Current suicide risk sufficient to preclude treatment on an outpatient basis
  • Chronic inflammatory or autoimmune disorder (e.g., rheumatoid arthritis, lupus)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (psychosocial intervention)
Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising MBSR, an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Patients will participate in a quality life assessment.
Other Names:
  • quality of life assessment
  • Ancillary studies
Procedure: psychosocial assessment and care
Participate in multi-component biobehavioral intervention
Other Names:
  • psychosocial assessment
  • psychosocial assessment/care
  • psychosocial care
  • psychosocial care/assessment
  • psychosocial studies
Behavioral: behavioral intervention
Participate in multi-component biobehavioral intervention
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
Other: cognitive intervention
A multi-component intervention based on cognitive and behavioral principles will be used. It combines effective intervention strategies selected for their relevance to patients with recurrent cancer.
Other: educational intervention
Participate in multi-component biobehavioral intervention
Other Names:
  • intervention, educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life(QoL)
Time Frame: up to 28 weeks
Quality of life as assessed by Short Form (SF)-36
up to 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood as assessed by the Profile of Mood States (POMS)
Time Frame: Up to 28 weeks
Up to 28 weeks
Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)
Time Frame: Up to 28 weeks
Up to 28 weeks
Stress as assessed by the Impact of Event Scale (IES)
Time Frame: Up to 28 weeks
Up to 28 weeks
Pain as assessed by the Brief Pain Inventory (BPI)
Time Frame: Up to 28 weeks
Up to 28 weeks
Fatigue as assessed by the Fatigue Severity Index (FSI)
Time Frame: Up to 28 weeks
Up to 28 weeks
Diurnal cortisol slope
Time Frame: Up to 28 weeks
Study participants will also collect saliva samples at home 4 times a day for 3 days. Saliva samples will be collected at the baseline, mid-treatment, post-treatment and 3-month follow-up assessments. These samples will be used to measure cortisol.
Up to 28 weeks
Inflammation
Time Frame: Up to 28 weeks
Blood samples will be used to measure levels of inflammatory markers. Blood draws will be coordinated with the participants' regularly scheduled blood draws to minimize discomfort.
Up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Barbara Andersen, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-10026
  • NCI-2012-01177 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R21CA135005 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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