- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01764789
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence
Study Overview
Status
Conditions
- Depression
- Pain
- Fatigue
- Pseudomyxoma Peritonei
- Peritoneal Carcinomatosis
- Recurrent Endometrial Carcinoma
- Anxiety Disorder
- Ovarian Sarcoma
- Recurrent Uterine Sarcoma
- Recurrent Breast Cancer
- Leydig Cell Tumor
- Recurrent Ovarian Epithelial Cancer
- Recurrent Primary Peritoneal Cavity Cancer
- Ovarian Stromal Cancer
- Recurrent Ovarian Germ Cell Tumor
- Recurrent Fallopian Tube Cancer
- Recurrent Cervical Cancer
- Recurrent Vaginal Cancer
- Recurrent Vulvar Cancer
- Recurrent Gestational Trophoblastic Tumor
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supportive care (psychosocial intervention)
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.
|
Ancillary studies
Patients will participate in a quality life assessment.
Other Names:
Participate in multi-component biobehavioral intervention
Other Names:
Participate in multi-component biobehavioral intervention
Other Names:
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.
Participate in multi-component biobehavioral intervention
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life(QoL)
Time Frame: up to 28 weeks
|
Quality of life as assessed by Short Form (SF)-36
|
up to 28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood as assessed by the Profile of Mood States (POMS)
Time Frame: Up to 28 weeks
|
Up to 28 weeks
|
|
Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)
Time Frame: Up to 28 weeks
|
Up to 28 weeks
|
|
Stress as assessed by the Impact of Event Scale (IES)
Time Frame: Up to 28 weeks
|
Up to 28 weeks
|
|
Pain as assessed by the Brief Pain Inventory (BPI)
Time Frame: Up to 28 weeks
|
Up to 28 weeks
|
|
Fatigue as assessed by the Fatigue Severity Index (FSI)
Time Frame: Up to 28 weeks
|
Up to 28 weeks
|
|
Diurnal cortisol slope
Time Frame: 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.
|
Up to 28 weeks
|
Inflammation
Time Frame: 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.
|
Up to 28 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Barbara Andersen, PhD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Digestive System Diseases
- Pathologic Processes
- Skin Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Testicular Diseases
- Breast Diseases
- Neoplasms, Germ Cell and Embryonal
- Pregnancy Complications
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Vaginal Diseases
- Vulvar Diseases
- Neoplasms, Cystic, Mucinous, and Serous
- Ovarian Neoplasms
- Pregnancy Complications, Neoplastic
- Neoplasms, Gonadal Tissue
- Sertoli-Leydig Cell Tumor
- Sex Cord-Gonadal Stromal Tumors
- Testicular Neoplasms
- Adenocarcinoma, Mucinous
- Sarcoma
- Breast Neoplasms
- Carcinoma
- Anxiety Disorders
- Recurrence
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Endometrial Neoplasms
- Carcinoma, Ovarian Epithelial
- Vulvar Neoplasms
- Trophoblastic Neoplasms
- Vaginal Neoplasms
- Pseudomyxoma Peritonei
- Leydig Cell Tumor
Other Study ID Numbers
- OSU-10026
- NCI-2012-01177 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R21CA135005 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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