Support for People Undergoing Chemotherapy

NCT00740038 | Completed

• 2 other identifiers: MCC-13782ACS RSGPB-05-0243-01 (CPPB)
• Study Type: interventional
• Target: 471
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Cancer

Keywords

Stress Management; Quality of Life; Exercise; Cancer; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Medical Outcomes Survey-Short Form (SF-36, acute)

  pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion

Secondary Outcomes (2)

• 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

Study Arms (4)

1

ACTIVE COMPARATOR

Active Control: Usual Care

Behavioral: Usual care

2

EXPERIMENTAL

Stress Management Intervention

Behavioral: Stress Management training

3

EXPERIMENTAL

Exercise Intervention

Behavioral: Exercise Training

4

EXPERIMENTAL

Combined Stress Management and Exercise Intervention

Behavioral: Combined stress management and exercise training

Interventions

Stress Management training BEHAVIORAL

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.

Also known as: Coping techniques, Cognitive-behavioral, stress management, Progressive muscle relaxation, Deep Breathing, Guided Imagery, Positive self-statements coping

2

Exercise Training BEHAVIORAL

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.

Also known as: Exercise program, Walking program, home-based exercise, exercise during chemotherapy

3

Usual care BEHAVIORAL

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.

Also known as: Active control group, Information on chemotherapy

1

Combined stress management and exercise training BEHAVIORAL

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.

Also known as: Stress management and exercise, Exercise and stress management, exercise during chemotherapy, Progressive muscle relaxation, Guided Imagery, Coping self-statements, walking program

4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (5)

• 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.

  BACKGROUND

• 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. doi: 10.1200/JCO.2003.04.093.

  PMID: 12721239 BACKGROUND

• 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. doi: 10.1002/pon.658.

  PMID: 12748973 BACKGROUND

• 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. doi: 10.1200/JCO.2002.08.301.

  PMID: 12065562 BACKGROUND

• 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.

  PMID: 22972771 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Coping Skills; Autogenic Training; Imagery, Psychotherapy; Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Paul B Jacobsen, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 22, 2008
• Study Start: August 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 23, 2017

Record last verified: 2011-08

Locations

US (1)