Support for People Undergoing Chemotherapy

• Center for Epidemiological Studies-Depression (CES-D) [ Time Frame: pre-chemotherapy baseline, 6- & 12- weeks post-baseline ] [ Designated as safety issue: No ]
• Beck Anxiety Inventory (BAI) [ Time Frame: pre-chemotherapy baseline, 6- & 12-weeks post-baseline ] [ Designated as safety issue: No ]

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.

• Quality of Life
• Cancer

• Behavioral: 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.
  Other Names:

  • Coping techniques
  • Cognitive-behavioral
  • stress management
  • Progressive muscle relaxation
  • Deep Breathing
  • Guided Imagery
  • Positive self-statements coping
• 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.
  Other Names:

  • Exercise program
  • Walking program
  • home-based exercise
  • exercise during chemotherapy
• 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.
  Other Names:

  • Active control group
  • Information on chemotherapy
• 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.
  Other Names:

  • Stress management and exercise
  • Exercise and stress management
  • exercise during chemotherapy
  • Progressive muscle relaxation
  • Guided Imagery
  • Coping self-statements
  • walking program

• Active Comparator: 1
  Active Control: Usual Care
  Intervention: Behavioral: Usual care
• Experimental: 2
  Stress Management Intervention
  Intervention: Behavioral: Stress Management training
• Experimental: 3
  Exercise Intervention
  Intervention: Behavioral: Exercise Training
• Experimental: 4
  Combined Stress Management and Exercise Intervention
  Intervention: Behavioral: Combined stress management and exercise training

• Courneya KS, Mackey JR, Bell GJ, Jones LW, Field CJ, Fairey AS. Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. J Clin Oncol. 2003 May 1;21(9):1660-8.
• Courneya KS, Friedenreich CM, Sela RA, Quinney HA, Rhodes RE, Handman M. The group psychotherapy and home-based physical exercise (group-hope) trial in cancer survivors: physical fitness and quality of life outcomes. Psychooncology. 2003 Jun;12(4):357-74.
• Jacobsen PB, Meade CD, Stein KD, Chirikos TN, Small BJ, Ruckdeschel JC. Efficacy and costs of two forms of stress management training for cancer patients undergoing chemotherapy. J Clin Oncol. 2002 Jun 15;20(12):2851-62.
• Phillips KM, Jim HS, Small BJ, Tanvetyanon T, Roberts WS, Jacobsen PB. Effects of self-directed stress management training and home-based exercise on stress management skills in cancer patients receiving chemotherapy. Stress Health. 2012 Dec;28(5):368-75. doi: 10.1002/smi.2450. Epub 2012 Sep 13.

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