Support for People Undergoing Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00740038|
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : February 23, 2017
Chemotherapy adversely affects quality of life in cancer patients. Both stress management training and exercise training have been shown to improve quality of life. These two types of training have not been directly compared for chemotherapy patients.
This study seeks to evaluate the separate and combined effects of stress management training and exercise training on quality of life during chemotherapy treatment. Participants receive either a home-based, self-administered program in 1 of 3 types (stress management, exercise, or stress management + exercise) or usual care (reading materials). It is hypothesized that the combined program (stress management + exercise) will be significantly associated with better quality of life than the usual care group, the exercise only group, and the stress management only group. All participants are assessed at 3 timepoints: before they begin chemotherapy, 6 weeks after their first chemotherapy infusion, and 12 weeks after their first infusion.
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life Cancer||Behavioral: Stress Management training Behavioral: Exercise Training Behavioral: Usual care Behavioral: Combined stress management and exercise training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||471 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Study of Stress Management and Exercise Intervention During Cancer Chemotherapy|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Active Comparator: 1
Active Control: Usual Care
Behavioral: Usual care
Usual psychosocial care and provision of NCI booklet, Chemotherapy and You (NCI, 1999) which gives general feedback about fitness testing, exercise and stress management during chemotherapy. Recommended to read booklet at least once.
Stress Management Intervention
Behavioral: Stress Management training
Self-administered stress management training comprising 10 minute introduction by staff, & provision of DVD, CD,brochure, and workbook. Materials provide overview of sources of stress during chemotherapy, and instruction in cognitive-behavioral stress management techniques (paced abdominal breathing, progressive muscle relaxation with guided imagery, and use of coping self-statements). Daily use is encouraged over 13-14 weeks of the study.
Behavioral: Exercise Training
Home-based exercise (walking) program: brief introduction by staff (10 minutes) and provision of packet with DVD, brochure, workbook, pedometer (electronic step counter) along with instructions on initiating and maintaining a walking program. Dose Recommendations: 3-5 exercise session per week for at least 20-30 minutes at maximum intensity of 50 to 75% of their estimated heart rate reserve (RPE of 11-13) which is calculated based on their age and resting pulse.
Combined Stress Management and Exercise Intervention
Behavioral: Combined stress management and exercise training
Home-based, self-administered stress management and exercise (walking) program: brief introduction by staff and provision of DVD, CD, brochure, pedometer, workbook. Dose Recommendations: walking/exercise program (3-5 times per week for at least 20-30 minutes) and use of CD (progressive muscle relaxation with guided imagery) and coping statements once per day.
- Medical Outcomes Survey-Short Form (SF-36, acute) [ Time Frame: pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion ]
- Center for Epidemiological Studies-Depression (CES-D) [ Time Frame: pre-chemotherapy baseline, 6- & 12- weeks post-baseline ]
- Beck Anxiety Inventory (BAI) [ Time Frame: pre-chemotherapy baseline, 6- & 12-weeks post-baseline ]
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): NCT00740038
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Paul B Jacobsen, PhD||Moffitt Cancer Center|