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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764789
First Posted: January 10, 2013
Last Update Posted: October 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Andersen, Ohio State University Comprehensive Cancer Center
  Purpose
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.

Condition Intervention
Anxiety Disorder Depression Fatigue Leydig Cell Tumor Ovarian Sarcoma Ovarian Stromal Cancer Pain Peritoneal Carcinomatosis Pseudomyxoma Peritonei Recurrent Breast Cancer Recurrent Cervical Cancer Recurrent Endometrial Carcinoma Recurrent Fallopian Tube Cancer Recurrent Gestational Trophoblastic Tumor Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Recurrent Primary Peritoneal Cavity Cancer Recurrent Uterine Sarcoma Recurrent Vaginal Cancer Recurrent Vulvar Cancer Other: questionnaire administration Procedure: quality-of-life assessment Procedure: psychosocial assessment and care Behavioral: behavioral intervention Other: cognitive intervention Other: educational intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence

Resource links provided by NLM:


Further study details as provided by Barbara Andersen, Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Quality of life(QoL) [ Time Frame: up to 28 weeks ]
    Quality of life as assessed by Short Form (SF)-36


Secondary Outcome Measures:
  • Mood as assessed by the Profile of Mood States (POMS) [ Time Frame: Up to 28 weeks ]
  • Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D) [ Time Frame: Up to 28 weeks ]
  • Stress as assessed by the Impact of Event Scale (IES) [ Time Frame: Up to 28 weeks ]
  • Pain as assessed by the Brief Pain Inventory (BPI) [ Time Frame: Up to 28 weeks ]
  • Fatigue as assessed by the Fatigue Severity Index (FSI) [ Time Frame: 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.

  • 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.


Enrollment: 39
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: intervention, educational

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764789


Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Barbara Andersen, PhD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Responsible Party: Barbara Andersen, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01764789     History of Changes
Other Study ID Numbers: OSU-10026
NCI-2012-01177 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
R21CA135005 ( U.S. NIH Grant/Contract )
First Submitted: January 8, 2013
First Posted: January 10, 2013
Last Update Posted: October 9, 2015
Last Verified: October 2015

Keywords provided by Barbara Andersen, Ohio State University Comprehensive Cancer Center:
psychological intervention
breast cancer
gynecologic cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Anxiety Disorders
Gestational Trophoblastic Disease
Breast Diseases
Skin Diseases
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Mental Disorders
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Vulvar Diseases
Vaginal Diseases
Genital Diseases, Male
Testicular Diseases
Breast Neoplasms
Sarcoma
Fatigue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endometrial Neoplasms
Germinoma
Carcinoma
Vulvar Neoplasms