Support for People Undergoing Chemotherapy

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Quality of Life; Cancer

Treatments: Behavioral: Combined stress management and exercise training; Behavioral: Stress Management training; Behavioral: Exercise Training; Behavioral: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT00740038

ACS RSGPB-05-0243-01 (CPPB)

MCC-13782

Details and patient eligibility

About

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.

Enrollment: 471 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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471 participants in 4 patient groups

1

Active Comparator group

Description:

Active Control: Usual Care

Treatment:

Behavioral: Usual care

2

Experimental group

Description:

Stress Management Intervention

Treatment:

Behavioral: Stress Management training

3

Experimental group

Description:

Exercise Intervention

Treatment:

Behavioral: Exercise Training

4

Experimental group

Description:

Combined Stress Management and Exercise Intervention

Treatment:

Behavioral: Combined stress management and exercise training