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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence

Conditions
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Pseudomyxoma Peritonei, Anxiety Disorder, Depression, Fatigue, Leydig Cell Tumor, Ovarian Sarcoma, Ovarian Stromal Cancer, Pain, Peritoneal Carcinomatosis, 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

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: quality-of-life assessment
* Procedure: psychosocial assessment and care
* Behavioral: behavioral intervention
* Other: cognitive intervention
* Other: educational intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (psychosocial intervention)<br>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<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Patients will participate in a quality life assessment.<br>* Other names: Ancillary studies;Procedure: psychosocial assessment and care<br>* Participate in multi-component biobehavioral intervention<br>* Other names: psychosocial studies;Behavioral: behavioral intervention<br>* Participate in multi-component biobehavioral intervention<br>* Other names: Behavioral Treatment;Other: cognitive intervention<br>* 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.<br>Other: educational intervention<br>* Participate in multi-component biobehavioral intervention<br>* Other names: intervention, educational;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life(QoL) | 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) |  | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychological intervention, breast cancer, gynecologic cancer