Support for People Undergoing Chemotherapy

February 20, 2017 updated by: H. Lee Moffitt Cancer Center and Research Institute

Study of Stress Management and Exercise Intervention During Cancer Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

471

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • Progressive muscle relaxation
  • Guided Imagery
  • stress management
  • Coping techniques
  • Cognitive-behavioral
  • Deep Breathing
  • 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:
  • walking program
  • Progressive muscle relaxation
  • Guided Imagery
  • exercise during chemotherapy
  • Stress management and exercise
  • Exercise and stress management
  • Coping self-statements

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Center for Epidemiological Studies-Depression (CES-D)
Time Frame: pre-chemotherapy baseline, 6- & 12- weeks post-baseline
pre-chemotherapy baseline, 6- & 12- weeks post-baseline
Beck Anxiety Inventory (BAI)
Time Frame: pre-chemotherapy baseline, 6- & 12-weeks post-baseline
pre-chemotherapy baseline, 6- & 12-weeks post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Paul B Jacobsen, PhD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (ESTIMATE)

August 22, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MCC-13782
  • ACS RSGPB-05-0243-01 (CPPB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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