Support for People Undergoing Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

471 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2012-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Quality of Life Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Active Control: Usual Care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type 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.

2

Stress Management Intervention

Group Type EXPERIMENTAL

Stress Management training

Intervention Type 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.

3

Exercise Intervention

Group Type EXPERIMENTAL

Exercise Training

Intervention Type 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.

4

Combined Stress Management and Exercise Intervention

Group Type EXPERIMENTAL

Combined stress management and exercise training

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Coping techniques Cognitive-behavioral stress management Progressive muscle relaxation Deep Breathing Guided Imagery Positive self-statements coping Exercise program Walking program home-based exercise exercise during chemotherapy Active control group Information on chemotherapy Stress management and exercise Exercise and stress management exercise during chemotherapy Progressive muscle relaxation Guided Imagery Coping self-statements walking program

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No