Clinical trial NCT01764789: Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
Official title: A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: psychological intervention
breast cancer
gynecologic cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-01-10
Enrollment: 39
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of life(QoL)
timeFrame: up to 28 weeks
Secondary outcomes:
measure: Mood as assessed by the Profile of Mood States (POMS)
timeFrame: Up to 28 weeks
measure: Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)
timeFrame: Up to 28 weeks
measure: Stress as assessed by the Impact of Event Scale (IES)
timeFrame: Up to 28 weeks
measure: Pain as assessed by the Brief Pain Inventory (BPI)
timeFrame: Up to 28 weeks
measure: Fatigue as assessed by the Fatigue Severity Index (FSI)
timeFrame: Up to 28 weeks
measure: Diurnal cortisol slope
timeFrame: Up to 28 weeks
measure: Inflammation
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Barbara Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: