Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
- Conditions
- Recurrent Endometrial CarcinomaRecurrent Ovarian Epithelial CancerRecurrent Vulvar CancerFatigueLeydig Cell TumorRecurrent Primary Peritoneal Cavity CancerPainAnxiety DisorderDepressionPeritoneal Carcinomatosis
- Interventions
- Other: questionnaire administrationProcedure: quality-of-life assessmentProcedure: psychosocial assessment and careBehavioral: behavioral interventionOther: cognitive interventionOther: educational intervention
- Registration Number
- NCT01764789
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 39
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Supportive care (psychosocial intervention) cognitive 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. Supportive care (psychosocial intervention) psychosocial assessment and care 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. Supportive care (psychosocial intervention) educational 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. Supportive care (psychosocial intervention) questionnaire administration 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. Supportive care (psychosocial intervention) quality-of-life assessment 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. Supportive care (psychosocial intervention) behavioral 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.
- Primary Outcome Measures
Name Time Method Quality of life(QoL) up to 28 weeks Quality of life as assessed by Short Form (SF)-36
- Secondary Outcome Measures
Name Time Method Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D) 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.
Stress as assessed by the Impact of Event Scale (IES) Up to 28 weeks 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.
Mood as assessed by the Profile of Mood States (POMS) Up to 28 weeks Pain as assessed by the Brief Pain Inventory (BPI) Up to 28 weeks
Trial Locations
- Locations (1)
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States