Support for People Undergoing Chemotherapy

Completed · Not applicable

Conditions studied: Quality of Life, Cancer

In brief

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.

Key facts

Study ID

NCT00740038

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

471

Starts

2006-08-01

Expected to finish

2012-08-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• . 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

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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