Stress Management Therapy in Patients Receiving Chemotherapy for Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00377130|
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : January 31, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Psychological Stress Unspecified Adult Solid Tumor, Protocol Specific||Other: Self Administered Stress Management||Not Applicable|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||442 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Stress Management Therapy for Patients Undergoing Chemotherapy|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
No Intervention: Arm I- Usual psychological care
Usual psychological care- no intervention
Experimental: Self administered Stress Management
Self-Administered Stress Management Training Plus Usual Psychosocial Care
Other: 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 Name: self-administered stress management training (SSMT)
- Quality of life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: After 4th chemotherapy cycle ]Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
- Degree of acculturation [ Time Frame: After 4th chemotherapy cycle ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377130
Show 51 Study Locations
|Study Chair:||Teletia Taylor, PhD||Howard University Cancer Center|
|Study Chair:||Susan McMillan, PhD RN FAAN||H. Lee Moffitt Cancer Center and Research Institute|