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Completed

NCT Number: NCT00740038

Support for People Undergoing 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.

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Key information

Conditions

Quality of Life Behavior Cancer Motor Activity Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • . metastases to weight-bearing sites (spine, pelvis, lower extremities)
  • . active infections
  • . cardiomyopathy or congestive heart failure
  • . severe pulmonary or ventilatory disease (FEV 1.0<50%)
  • . large pleural effusions or pericardial effusions
  • . anemia (Hgb <8g/dL)
  • . neutropenia (absolute neutrophil count < 0.05 x 10(9th)/L)
  • . severe osteoporosis (> 2.5 SD below age and gender norms)
  • . thrombocytopenia (platelets < 20 x 10(9th)/L)
  • . hyponatremia (Na+ < 130 mmol/L)
  • . hypokalemia (K+ ≤ 3.0 mmol/L)
  • . hypercalcemia (Ca++ > 6.5 mmol/L)
  • . abnormal ECG
  • . 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

Treatment and study plan

Stress Management Training

Behavioral

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

Exercise Training

Behavioral

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

Usual Care

Behavioral

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

Combined stress management and exercise training

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Study of Stress Management and Exercise Intervention During Cancer Chemotherapy

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Aug 22, 2008
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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