Support for People Undergoing Chemotherapy

Study Overview
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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.

Official Title
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Study of Stress Management and Exercise Intervention During Cancer Chemotherapy

Conditions
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Quality of Life, Cancer

Intervention / Treatment
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* Behavioral: Stress Management training
* Behavioral: Exercise Training
* Behavioral: Usual care
* Behavioral: Combined stress management and exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Active Control: Usual Care | Behavioral: Usual care<br>* 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.<br>* Other names: Information on chemotherapy;|
| Experimental: 2<br>Stress Management Intervention | Behavioral: Stress Management training<br>* 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.<br>* Other names: Positive self-statements coping;|
| Experimental: 3<br>Exercise Intervention | Behavioral: Exercise Training<br>* 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.<br>* Other names: exercise during chemotherapy;|
| Experimental: 4<br>Combined Stress Management and Exercise Intervention | Behavioral: Combined stress management and exercise training<br>* 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.<br>* Other names: walking program;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Management, Quality of Life, Exercise, Cancer, Chemotherapy