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

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.

• questionnaire administration (Other): Ancillary studies
• quality-of-life assessment (Procedure), also known as quality of life assessment, Ancillary studies: Patients will participate in a quality life assessment.
• psychosocial assessment and care (Procedure), also known as psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment, psychosocial studies: Participate in multi-component biobehavioral intervention
• behavioral intervention (Behavioral), also known as Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment: Participate in multi-component biobehavioral intervention
• cognitive intervention (Other): 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.
• educational intervention (Other), also known as intervention, educational: Participate in multi-component biobehavioral intervention

Primary outcomes

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

Secondary outcomes

• 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.

Sex: Female, ages: 21 Years to 85 Years

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)

• Barbara Andersen, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center

NIH grants: R21CA135005