Support for People Undergoing Chemotherapy

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. Identifier: NCT00740038
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : February 23, 2017
American Cancer Society, Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Other Names:
  • Active control group
  • Information on chemotherapy

Experimental: 2
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.
Other Names:
  • Coping techniques
  • Cognitive-behavioral
  • stress management
  • Progressive muscle relaxation
  • Deep Breathing
  • Guided Imagery
  • Positive self-statements coping

Experimental: 3
Exercise Intervention
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.
Other Names:
  • Exercise program
  • Walking program
  • home-based exercise
  • exercise during chemotherapy

Experimental: 4
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.
Other Names:
  • Stress management and exercise
  • Exercise and stress management
  • exercise during chemotherapy
  • Progressive muscle relaxation
  • Guided Imagery
  • Coping self-statements
  • walking program

Primary Outcome Measures :
  1. Medical Outcomes Survey-Short Form (SF-36, acute) [ Time Frame: pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion ]

Secondary Outcome Measures :
  1. Center for Epidemiological Studies-Depression (CES-D) [ Time Frame: pre-chemotherapy baseline, 6- & 12- weeks post-baseline ]
  2. Beck Anxiety Inventory (BAI) [ Time Frame: pre-chemotherapy baseline, 6- & 12-weeks post-baseline ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: participants must:

  • Be diagnosed with cancer
  • Be scheduled to receive cytotoxic chemotherapy for at least 14 weeks
  • Be ≥18 years of age or older
  • Have an ECOG performance status of 0, 1, or 2
  • Be capable of speaking and reading English
  • Be able to provide informed consent

Exclusion Criteria:

  • ECOG of 3 or greater
  • Presence of contraindications to participating in moderate intensity exercise including:

    1. . metastases to weight-bearing sites (spine, pelvis, lower extremities)
    2. . active infections
    3. . cardiomyopathy or congestive heart failure
    4. . severe pulmonary or ventilatory disease (FEV 1.0<50%)
    5. . large pleural effusions or pericardial effusions
    6. . anemia (Hgb <8g/dL)
    7. . neutropenia (absolute neutrophil count < 0.05 x 10(9th)/L)
    8. . severe osteoporosis (> 2.5 SD below age and gender norms)
    9. . thrombocytopenia (platelets < 20 x 10(9th)/L)
    10. . hyponatremia (Na+ < 130 mmol/L)
    11. . hypokalemia (K+ ≤ 3.0 mmol/L)
    12. . hypercalcemia (Ca++ > 6.5 mmol/L)
    13. . abnormal ECG
    14. . sensorimotor deficits sufficient to impede unassisted walking
  • Receipt of intravenous chemotherapy administration in the past 2 months
  • Prescription for chronotropic, sympathomimetic, or inotropic/vasoactive medications
  • Presence of other contraindications as determined by the attending oncologist and research staff

Information from the National Library of Medicine

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 identifier (NCT number): NCT00740038

United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
American Cancer Society, Inc.
Principal Investigator: Paul B Jacobsen, PhD Moffitt Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT00740038     History of Changes
Other Study ID Numbers: MCC-13782
ACS RSGPB-05-0243-01 (CPPB)
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: August 2011

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Stress Management
Quality of Life