Support for People Undergoing Chemotherapy

Cancer Clinical Trial

Official title:

Study of Stress Management and Exercise Intervention During Cancer Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740038
• Other study ID #: MCC-13782
• Secondary ID: ACS RSGPB-05-024
• Status: Completed
• Phase: N/A
• First received: August 21, 2008
• Last updated: February 20, 2017
• Start date: August 2006
• Est. completion date: August 2012

Study information

• Verified date: August 2011
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Quality of Life

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Courneya KS, Mackey JR, & Quinney HA. Neoplasms. In Myers, Herbert, Humphrey (eds): American College of Sports Medicine resources for clinical exercise physiology: musculoskeletal, neuromuscular, immunologic, and hematologic conditions. New York: Lippincott.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical Outcomes Survey-Short Form (SF-36, acute)		pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion
Secondary	Center for Epidemiological Studies-Depression (CES-D)		pre-chemotherapy baseline, 6- & 12- weeks post-baseline
Secondary	Beck Anxiety Inventory (BAI)		pre-chemotherapy baseline, 6- & 12-weeks post-baseline