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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Andersen, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01764789
First received: January 8, 2013
Last updated: May 20, 2014
Last verified: May 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Quality of life(QoL) [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D) [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: No ]
  • Stress as assessed by the Impact of Event Scale (IES) [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: No ]
  • Pain as assessed by the Brief Pain Inventory (BPI) [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: No ]
  • Fatigue as assessed by the Fatigue Severity Index (FSI) [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: No ]
  • Diurnal cortisol slope [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 48
Study Start Date: October 2010
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   21 Years to 85 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764789

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

Additional Information:
No publications provided

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, R21CA135005
Study First Received: January 8, 2013
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anxiety Disorders
Depressive Disorder
Vaginal Neoplasms
Mental Disorders
Breast Diseases
Skin Diseases
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Mood Disorders
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Vaginal Diseases
Vulvar Diseases
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Adnexal Diseases
Ovarian Diseases
Breast Neoplasms
Carcinoma
Uterine Cervical Neoplasms
Depression
Fatigue
Leydig Cell Tumor
Pseudomyxoma Peritonei
Trophoblastic Neoplasms
Vulvar Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014