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

The Ohio State University

Status: Completed

Conditions: Recurrent Endometrial Carcinoma; Anxiety Disorder; Recurrent Ovarian Germ Cell Tumor; Recurrent Ovarian Epithelial Cancer; Recurrent Fallopian Tube Cancer; Recurrent Cervical Cancer; Recurrent Gestational Trophoblastic Tumor; Fatigue; Recurrent Primary Peritoneal Cavity Cancer; Recurrent Vaginal Cancer; Leydig Cell Tumor; Recurrent Uterine Sarcoma; Recurrent Vulvar Cancer; Ovarian Stromal Cancer; Ovarian Sarcoma; Depression; Recurrent Breast Cancer; Pain; Pseudomyxoma Peritonei; Peritoneal Carcinomatosis

Treatments: Other: questionnaire administration; Other: cognitive intervention; Procedure: psychosocial assessment and care; Behavioral: behavioral intervention; Other: educational intervention; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01764789

OSU-10026

NCI-2012-01177 (Registry Identifier)

R21CA135005 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 21 to 85 years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

39 participants in 1 patient group

Supportive care (psychosocial intervention)

Experimental group

Description:

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.

Treatment:

Procedure: quality-of-life assessment

Other: educational intervention

Behavioral: behavioral intervention

Other: questionnaire administration

Other: cognitive intervention

Procedure: psychosocial assessment and care