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| ID | Type | Description | Link |
|---|---|---|---|
| ACS RSGPB-05-0243-01 (CPPB) |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Active Control: Usual Care |
|
| 2 | Experimental | Stress Management Intervention |
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| 3 | Experimental | Exercise Intervention |
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| 4 | Experimental | Combined Stress Management and Exercise Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Outcomes Survey-Short Form (SF-36, acute) | pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion |
| Measure | Description | 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 |
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Inclusion Criteria: participants must:
Exclusion Criteria:
ECOG of 3 or greater
Presence of contraindications to participating in moderate intensity exercise including:
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
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| Name | Affiliation | Role |
|---|---|---|
| Paul B Jacobsen, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 12721239 | 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. | |
| 12748973 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000097813 | Coping Skills |
| D001326 | Autogenic Training |
| D019018 | Imagery, Psychotherapy |
| D015444 | Exercise |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D006990 | Hypnosis |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| 12065562 | 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. |
| 22972771 | Derived | 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. |
| D026441 |
| Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |