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
Conditions
Keywords
psychological intervention, breast cancer, gynecologic cancer
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.
Interventions
OTHERquestionnaire administration
Ancillary studies
PROCEDUREquality-of-life assessment
Patients will participate in a quality life assessment.
PROCEDUREpsychosocial assessment and care
Participate in multi-component biobehavioral intervention
BEHAVIORALbehavioral intervention
Participate in multi-component biobehavioral intervention
OTHERcognitive intervention
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.
OTHEReducational intervention
Participate in multi-component biobehavioral intervention
Sponsors
National Cancer Institute (NCI)
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life(QoL) | up to 28 weeks | Quality of life as assessed by Short Form (SF)-36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Mood as assessed by the Profile of Mood States (POMS) | 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. |
| Fatigue as assessed by the Fatigue Severity Index (FSI) | Up to 28 weeks | — |
Countries
United States
Outcome results
None listed