Stress Management Therapy in Patients Receiving Chemotherapy for Cancer
NCT ID: NCT00377130
Last Updated: 2014-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
442 participants
INTERVENTIONAL
2006-12-31
2010-05-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well stress management therapy works in patients receiving chemotherapy for cancer.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I- Usual psychological care
Usual psychological care- no intervention
No interventions assigned to this group
Self administered Stress Management
Self-Administered Stress Management Training Plus Usual Psychosocial Care
Self Administered Stress Management
The SSMT kit includes a DVD and booklet will discuss the sources and manifestations of stress during chemotherapy and the potential benefits of stress management training. The videotape/DVD and booklet will also include brief instruction in paced breathing, progressive muscle relaxation with guided imagery, and use of coping self-statements as well as recommendations for practicing the techniques before the start of chemotherapy and using them after the start of treatment. The exercise combines abbreviated progressive muscle relaxation training with use of relaxing mental imagery. The "positive thinking" exercise provides participants with brief instruction in the use of coping self-statements using techniques borrowed from stress inoculation training.
Interventions
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Self Administered Stress Management
The SSMT kit includes a DVD and booklet will discuss the sources and manifestations of stress during chemotherapy and the potential benefits of stress management training. The videotape/DVD and booklet will also include brief instruction in paced breathing, progressive muscle relaxation with guided imagery, and use of coping self-statements as well as recommendations for practicing the techniques before the start of chemotherapy and using them after the start of treatment. The exercise combines abbreviated progressive muscle relaxation training with use of relaxing mental imagery. The "positive thinking" exercise provides participants with brief instruction in the use of coping self-statements using techniques borrowed from stress inoculation training.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed with cancer
* Scheduled to receive a minimum of 4 cycles of intravenous chemotherapy
* Able and willing to give informed consent to participate
Exclusion Criteria
* Are scheduled to receive radiotherapy prior to the end of the fourth cycle
* Have severe depression or other severe psychiatric disorders
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Teletia Taylor, PhD
Role: STUDY_CHAIR
Howard University Cancer Center
Susan McMillan, PhD RN FAAN
Role: STUDY_CHAIR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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Contra Costa Regional Medical Center
Martinez, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Howard University Cancer Center
Washington D.C., District of Columbia, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, United States
Savoy Medical Center
Mamou, Louisiana, United States
Louisiana State University Health Sciences Center - Monroe
Monroe, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States
CCOP - Beaumont
Royal Oak, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy Campus
Troy, Michigan, United States
MeritCare Bemidji
Bemidji, Minnesota, United States
St. John's Regional Health Center
Springfield, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, United States
Dickstein Cancer Treatment Center at White Plains Hospital Center
White Plains, New York, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, United States
High Point Regional Hospital
High Point, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Southeastern Medical Oncology Center - Wilson
Wilson, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, United States
Roger Maris Cancer Center at MeritCare Hospital
Fargo, North Dakota, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grant Medical Center Cancer Care
Columbus, Ohio, United States
Mount Carmel Hospital East
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Mount Carmel St. Ann's Cancer Center
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Springfield Regional Cancer Center
Springfield, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Scott and White Cancer Institute
Temple, Texas, United States
Rainier Physicians - NWMS
Puyallup, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Andres Grillasca Hospital
Ponce, , Puerto Rico
Hato Rey Hematology/Oncology Group, PSC
San Juan, , Puerto Rico
I. Gonzalez Martinez Oncologic Hospital
San Juan, , Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan, , Puerto Rico
San Juan City Hospital
San Juan, , Puerto Rico
Countries
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Other Identifiers
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SCUSF-0501
Identifier Type: OTHER
Identifier Source: secondary_id
HLMCC-0501
Identifier Type: OTHER
Identifier Source: secondary_id
SCUSF 0501
Identifier Type: -
Identifier Source: org_study_id
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