Stress Management Therapy in Patients Receiving Chemotherapy for Cancer
- Conditions
- CancerPsychological StressUnspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Other: Self Administered Stress Management
- Registration Number
- NCT00377130
- Lead Sponsor
- University of South Florida
- Brief Summary
RATIONALE: A stress-management program may improve quality of life and reduce anxiety and depression in patients receiving chemotherapy for cancer.
PURPOSE: This randomized clinical trial is studying how well stress management therapy works in patients receiving chemotherapy for cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine if a self-administered stress management intervention is effective in improving quality of life and decreasing psychological distress (anxiety and depression) in Hispanic and non-Hispanic patients receiving cancer chemotherapy.
Secondary
* Determine if the degree of acculturation in Hispanics influences the observed helpfulness of the intervention.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, use of psychotropic drugs (yes vs no), and ethnicity (Hispanic vs non-Hispanic). Patients are randomized to 1 of 2 arms.
* Arm I (self-administered stress management training plus usual psychosocial care): Patients receive a video DVD, audio CD, and brochure that provides information and instruction in 3 stress management training techniques (progressive muscle relaxation training and guided imagery, abdominal breathing, and coping skills training) to use during chemotherapy. Patients also receive usual psychosocial care.
* Arm II (usual psychosocial care only): Patients receive usual psychosocial care.
Patients complete questionnaires to assess mood, quality of life, and other factors at baseline and before chemotherapy courses 2, 3, and 4.
PROJECTED ACCRUAL: A total of 442 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 442
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self administered Stress Management Self Administered Stress Management Self-Administered Stress Management Training Plus Usual Psychosocial Care
- Primary Outcome Measures
Name Time Method Quality of life After 4th chemotherapy cycle Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Anxiety after 4th chemotherapy cycle Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Depression After 4th chemotherapy cycle Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
- Secondary Outcome Measures
Name Time Method Degree of acculturation After 4th chemotherapy cycle Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Trial Locations
- Locations (51)
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
๐บ๐ธShreveport, Louisiana, United States
MBCCOP - JHS Hospital of Cook County
๐บ๐ธChicago, Illinois, United States
CCOP - Beaumont
๐บ๐ธRoyal Oak, Michigan, United States
St. John's Regional Health Center
๐บ๐ธSpringfield, Missouri, United States
Newark Beth Israel Medical Center
๐บ๐ธNewark, New Jersey, United States
CCOP - Bay Area Tumor Institute
๐บ๐ธOakland, California, United States
CCOP - Southeast Cancer Control Consortium
๐บ๐ธGoldsboro, North Carolina, United States
Contra Costa Regional Medical Center
๐บ๐ธMartinez, California, United States
Adena Regional Medical Center
๐บ๐ธChillicothe, Ohio, United States
Hulston Cancer Center at Cox Medical Center South
๐บ๐ธSpringfield, Missouri, United States
CCOP - Cancer Research for the Ozarks
๐บ๐ธSpringfield, Missouri, United States
Mount Carmel Hospital East
๐บ๐ธColumbus, Ohio, United States
Pardee Memorial Hospital
๐บ๐ธHendersonville, North Carolina, United States
High Point Regional Hospital
๐บ๐ธHigh Point, North Carolina, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
๐บ๐ธNewark, Ohio, United States
CCOP - Columbus
๐บ๐ธColumbus, Ohio, United States
Hato Rey Hematology/Oncology Group, PSC
๐ต๐ทSan Juan, Puerto Rico
Genesis - Good Samaritan Hospital
๐บ๐ธZanesville, Ohio, United States
Scott and White Cancer Institute
๐บ๐ธTemple, Texas, United States
Roger Maris Cancer Center at MeritCare Hospital
๐บ๐ธFargo, North Dakota, United States
CCOP - MeritCare Hospital
๐บ๐ธFargo, North Dakota, United States
MeritCare Bemidji
๐บ๐ธBemidji, Minnesota, United States
Andres Grillasca Hospital
๐ต๐ทPonce, Puerto Rico
Bay Area Tumor Institute
๐บ๐ธOakland, California, United States
Iredell Memorial Hospital
๐บ๐ธStatesville, North Carolina, United States
Mount Carmel Health - West Hospital
๐บ๐ธColumbus, Ohio, United States
Doctors Hospital at Ohio Health
๐บ๐ธColumbus, Ohio, United States
Rainier Physicians - NWMS
๐บ๐ธPuyallup, Washington, United States
Louisiana State University Health Sciences Center - Monroe
๐บ๐ธMonroe, Louisiana, United States
Dickstein Cancer Treatment Center at White Plains Hospital Center
๐บ๐ธWhite Plains, New York, United States
Southeastern Medical Oncology Center - Goldsboro
๐บ๐ธGoldsboro, North Carolina, United States
Riverside Methodist Hospital Cancer Care
๐บ๐ธColumbus, Ohio, United States
Southeastern Medical Oncology Center - Wilson
๐บ๐ธWilson, North Carolina, United States
Grant Medical Center Cancer Care
๐บ๐ธColumbus, Ohio, United States
Mount Carmel St. Ann's Cancer Center
๐บ๐ธColumbus, Ohio, United States
Springfield Regional Cancer Center
๐บ๐ธSpringfield, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
๐บ๐ธMarietta, Ohio, United States
CCOP - Northwest
๐บ๐ธTacoma, Washington, United States
CCOP - Scott and White Hospital
๐บ๐ธTemple, Texas, United States
John H. Stroger, Jr. Hospital of Cook County
๐บ๐ธChicago, Illinois, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
๐บ๐ธWinston-Salem, North Carolina, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
๐บ๐ธBronx, New York, United States
Savoy Medical Center
๐บ๐ธMamou, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
๐บ๐ธShreveport, Louisiana, United States
I. Gonzalez Martinez Oncologic Hospital
๐ต๐ทSan Juan, Puerto Rico
William Beaumont Hospital - Royal Oak Campus
๐บ๐ธRoyal Oak, Michigan, United States
Howard University Cancer Center
๐บ๐ธWashington, District of Columbia, United States
William Beaumont Hospital - Troy Campus
๐บ๐ธTroy, Michigan, United States
Veterans Affairs Medical Center - San Juan
๐ต๐ทSan Juan, Puerto Rico
San Juan City Hospital
๐ต๐ทSan Juan, Puerto Rico
Grady Memorial Hospital
๐บ๐ธDelaware, Ohio, United States