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

Depression Clinical Trial

Official title:

A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764789
• Other study ID #: OSU-10026
• Secondary ID: NCI-2012-01177R2
• Status: Completed
• Phase: N/A
• First received: January 8, 2013
• Last updated: October 8, 2015
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2015
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 85 Years

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Breast Neoplasms
• Depression
• Endometrial Neoplasms
• Fatigue
• Germinoma
• Gestational Trophoblastic Disease
• Leydig Cell Tumor
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Ovarian Sarcoma
• Ovarian Stromal Cancer
• Pain
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms
• 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
• Sarcoma
• Trophoblastic Neoplasms
• Uterine Cervical Neoplasms
• Vaginal Neoplasms
• Vulvar Neoplasms

Intervention

Other:
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Patients will participate in a quality life assessment.
• psychosocial assessment and care
Participate in multi-component biobehavioral intervention

Behavioral:
• behavioral intervention
Participate in multi-component biobehavioral intervention

Other:
• cognitive 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.
• educational intervention
Participate in multi-component biobehavioral intervention

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life(QoL)	Quality of life as assessed by Short Form (SF)-36	up to 28 weeks	No
Secondary	Mood as assessed by the Profile of Mood States (POMS)		Up to 28 weeks	No
Secondary	Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)		Up to 28 weeks	No
Secondary	Stress as assessed by the Impact of Event Scale (IES)		Up to 28 weeks	No
Secondary	Pain as assessed by the Brief Pain Inventory (BPI)		Up to 28 weeks	No
Secondary	Fatigue as assessed by the Fatigue Severity Index (FSI)		Up to 28 weeks	No
Secondary	Diurnal cortisol slope	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.	Up to 28 weeks	No
Secondary	Inflammation	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.	Up to 28 weeks	No

External Links

•   The Jamesline