Healthy Exercise for Lymphoma Patients (HELP) (HELP)
Recruitment status was: Active, not recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Randomized Controlled Trial of Exercise in Lymphoma Patients|
- Change in QoL between baseline and postintervention. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Changes in cardiopulmonary fitness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- psychosocial outcomes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- treatment completion rates [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||April 2009|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Aerobic Exercise Training
Behavioral: Aerobic Exercise Training
The exercise group will perform supervised stationary cycle ergometer exercise 3 days/week for 12 weeks and be progressed from 15 to 45 minutes and 60% to 80% of their VO2 reserve over the course of the intervention.
|No Intervention: Usual Care|
Design and Setting: The study is a randomized controlled trial. It will be conducted at the University of Alberta and Cross Cancer Institute in Edmonton, Alberta, Canada.
Participants: Participants will be 120 lymphoma survivors diagnosed with either non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) and receiving or not receiving at least 8 weeks of chemotherapy at the Cross Cancer Institute in Edmonton, Alberta. Participants will be stratified by disease type (indolent NHL versus aggressive NHL versus HD) and planned chemotherapy protocol (no chemotherapy versus < 16 weeks versus > 16 weeks), and randomly assigned to either a 12 week exercise program or usual care.
Eligibility: Participants will be recruited from the Cross Cancer Institute. The eligibility criteria include medical, demographic, and logistic criterion, and are focused on internal validity as well as external validity. Eligibility criteria for the study are: (1) histologically confirmed lymphoma cancer, (2) 18 years of age or older, (3) not receiving chemotherapy or scheduled to receive at least 2 cycles (8 weeks) of chemotherapy, excluding high dose chemotherapy with stem cell transplant, (4) approval of the treating oncologist, (5) able to understand and provide written informed consent in English, (6) no uncontrolled hypertension, (7) no uncontrolled cardiac illness, (8) no active psychiatric condition, and (9) no contraindications to exercise as determined by a maximal fitness test conducted by a certified fitness consultant (CFC).
Recruitment: We have recruited 122 participants to the trial. The study is now closed to accrual.
Recruitment will take place at the treatment or follow-up consultation with the medical or radiation oncologist. Interested survivors will receive an information package from the oncologist and a follow-up telephone call from the project director who will explain the study further and answer any questions. All individuals who are interested in participating in the study will: (a) be asked to provide informed consent, (b) complete a self administered questionnaire, and (c) be scheduled for a maximal physical fitness test, a dual-x-ray absorptiometry (DEXA) scan, and a blood draw. The physical fitness test will determine final eligibility for the study.
Interventions: The exercise group will perform supervised stationary cycle ergometer exercise 3 days/week for 12 weeks and be progressed from 15 to 45 minutes and 60% to 80% of their VO2 reserve over the course of the intervention. The usual care group will be asked not to begin a structured exercise training program during the next 12 weeks and will receive the exercise for 4 weeks following the postintervention assessment.
End Points: The primary end point is change in the Trial Outcome Index of QoL between baseline and postintervention. QoL will be assessed by the Functional Assessment of Cancer Therapy-Anemia (FACT-An) scale (Trial Outcome Index: Physical Well-being, Functional Well-being and Anemia Subscales). Secondary end points are changes in psychosocial outcomes, cardiopulmonary fitness, body composition, and treatment completion rates. Cardiopulmonary fitness will be assessed by a graded exercise test using gas exchange analysis. Body composition will be assessed by body mass index and a DEXA scan. Treatment completion rates will be assessed as the number of chemotherapy cycles received divided by the number planned.
Sample Size: Sample size calculation is based on the primary end point. A clinically important difference (CID) in the TOI of the FACT-An is 6.0 points. Sixty participants in each group will allow us to detect a 10.0 point difference in between group changes with a power of .80 and a two-tailed a of .05 (standard deviation = 18.0 points).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111865
|University of Alberta|
|Edmonton, Alberta, Canada, T6G2H9|
|Principal Investigator:||Kerry S Courneya, Ph.D.||University of Alberta|