Support for People Undergoing Chemotherapy

Not Applicable

Completed

• Conditions: Quality of Life; Cancer
• Interventions: Behavioral: Usual care; Behavioral: Stress Management training; Behavioral: Exercise Training; Behavioral: Combined stress management and exercise training

• Registration Number: NCT00740038
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Status Verified: 2011-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 471

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Usual care	Active Control: Usual Care
2	Stress Management training	Stress Management Intervention
3	Exercise Training	Exercise Intervention
4	Combined stress management and exercise training	Combined Stress Management and Exercise Intervention

Primary Outcome Measures

Name	Time	Method
Medical Outcomes Survey-Short Form (SF-36, acute)	pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States