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

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01764789

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
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	N/A

Detailed Description

PRIMARY OBJECTIVES:

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

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

N/A

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Quality of life(QoL) [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) [Up to 28 weeks]
Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D) [Up to 28 weeks]
Stress as assessed by the Impact of Event Scale (IES) [Up to 28 weeks]
Pain as assessed by the Brief Pain Inventory (BPI) [Up to 28 weeks]
Fatigue as assessed by the Fatigue Severity Index (FSI) [Up to 28 weeks]
Diurnal cortisol slope [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)