Support for People Undergoing Chemotherapy

H. Lee Moffitt Cancer Center and Research Institute471 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

471

Conditions

Quality of Life Cancer

Interventions

Stress Management trainingBEHAVIORAL

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.

Exercise TrainingBEHAVIORAL

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.

Usual careBEHAVIORAL

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.

Combined stress management and exercise trainingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Center for Epidemiological Studies-Depression (CES-D)

Time frame: pre-chemotherapy baseline, 6- & 12- weeks post-baseline

Beck Anxiety Inventory (BAI)

Time frame: pre-chemotherapy baseline, 6- & 12-weeks post-baseline