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

Primary Purpose

Anxiety Disorder, Depression, Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
questionnaire administration
quality-of-life assessment
psychosocial assessment and care
behavioral intervention
cognitive intervention
educational intervention
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Disorder focused on measuring psychological intervention, breast cancer, gynecologic cancer

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (psychosocial intervention)

Arm 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.

Outcomes

Primary Outcome Measures

Quality of life(QoL)
Quality of life as assessed by Short Form (SF)-36

Secondary Outcome Measures

Mood as assessed by the Profile of Mood States (POMS)
Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)
Stress as assessed by the Impact of Event Scale (IES)
Pain as assessed by the Brief Pain Inventory (BPI)
Fatigue as assessed by the Fatigue Severity Index (FSI)
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.
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.

Full Information

First Posted
January 8, 2013
Last Updated
October 8, 2015
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01764789
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (psychosocial intervention)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment, Ancillary studies
Intervention Description
Patients will participate in a quality life assessment.
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Other Intervention Name(s)
psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment, psychosocial studies
Intervention Description
Participate in multi-component biobehavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
behavioral intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment
Intervention Description
Participate in multi-component biobehavioral intervention
Intervention Type
Other
Intervention Name(s)
cognitive intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Participate in multi-component biobehavioral intervention
Primary Outcome Measure Information:
Title
Quality of life(QoL)
Description
Quality of life as assessed by Short Form (SF)-36
Time Frame
up to 28 weeks
Secondary Outcome Measure Information:
Title
Mood as assessed by the Profile of Mood States (POMS)
Time Frame
Up to 28 weeks
Title
Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D)
Time Frame
Up to 28 weeks
Title
Stress as assessed by the Impact of Event Scale (IES)
Time Frame
Up to 28 weeks
Title
Pain as assessed by the Brief Pain Inventory (BPI)
Time Frame
Up to 28 weeks
Title
Fatigue as assessed by the Fatigue Severity Index (FSI)
Time Frame
Up to 28 weeks
Title
Diurnal cortisol slope
Description
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.
Time Frame
Up to 28 weeks
Title
Inflammation
Description
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.
Time Frame
Up to 28 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Andersen, PhD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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