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Study of Stress Management and Exercise Intervention During Cancer Chemotherapy

Phase 2/Phase 3
18 Years
Not Enrolling
Quality of Life, Cancer

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Trial Information

Study of Stress Management and Exercise Intervention During Cancer Chemotherapy

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Paul B Jacobsen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Moffitt Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2006

Completion Date:

August 2012

Related Keywords:

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



Moffitt Cancer CenterTampa, Florida  33612