Clinical trial NCT00740038: Support for People Undergoing Chemotherapy
Official title: Study of Stress Management and Exercise Intervention During Cancer Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Cancer
Keywords: Stress Management
Quality of Life
Exercise
Cancer
Chemotherapy
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2008-08-22
Enrollment: 471
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Medical Outcomes Survey-Short Form (SF-36, acute)
timeFrame: pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion
Secondary outcomes:
measure: Center for Epidemiological Studies-Depression (CES-D)
timeFrame: pre-chemotherapy baseline, 6- & 12- weeks post-baseline
measure: Beck Anxiety Inventory (BAI)
timeFrame: pre-chemotherapy baseline, 6- & 12-weeks post-baseline
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Paul B Jacobsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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. doi: 10.1200/JCO.2002.08.301.
citation: 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.