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Support for People Undergoing Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Paul Jacobsen, H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00740038
First received: August 21, 2008
Last updated: September 11, 2012
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Quality of Life
Cancer
 Behavioral: Stress Management training
Behavioral: Exercise Training
Behavioral: Usual care
Behavioral: Combined stress management and exercise training
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Study of Stress Management and Exercise Intervention During Cancer Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Medical Outcomes Survey-Short Form (SF-36, acute) [ Time Frame: pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Center for Epidemiological Studies-Depression (CES-D) [ Time Frame: pre-chemotherapy baseline, 6- & 12- weeks post-baseline ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: pre-chemotherapy baseline, 6- & 12-weeks post-baseline ] [ Designated as safety issue: No ]

Enrollment: 471
Study Start Date: August 2006
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740038

Locations
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.
Investigators
Principal Investigator: Paul B Jacobsen, PhD Moffitt Cancer Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paul Jacobsen, Study Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00740038     History of Changes
Other Study ID Numbers: MCC-13782, ACS RSGPB-05-0243-01 (CPPB)
Study First Received: August 21, 2008
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013