Quality of Life, Cancer
Conditions
Keywords
Stress Management, Quality of Life, Exercise, Cancer, Chemotherapy
Brief summary
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.
Interventions
BEHAVIORALStress 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.
BEHAVIORALExercise 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.
BEHAVIORALUsual 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.
BEHAVIORALCombined 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.
Sponsors
American Cancer Society, Inc.
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medical Outcomes Survey-Short Form (SF-36, acute) | pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed