Multiphasic Prehab Allo-HSCT
- Conditions
- Leukemia
- Interventions
- Other: Prehabilitation
- Registration Number
- NCT05649371
- Lead Sponsor
- University of Calgary
- Brief Summary
The purpose of this study is to implement a prehabilitation intervention to enhance recovery for people undergoing allogeneic stem cell transplant for hematologic malignancies. All participants in this study will receive a prehabilation intervention in addition to usual care (no change to their chemotherapy protocols or transplant) and several quality of life and fitness scores will be measured throughout the intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Adult patients, 18 years or older, undergoing an allo-HSCT for acute leukemia.
- Approval to engage in exercise as per screening by the CSEP or ACSM certified CEP and/or clinician
- Ability to provide written informed consent and understand study information.
- Less than 18 years old
- Diagnosed with acute leukemia but not undergoing work-up for allo-HSCT
- Unable to read/communicate in English (i.e., unable to complete experimental procedures such as patient-reported outcomes).
- Neurological or musculoskeletal comorbidity inhibiting exercise.
- Diagnosed psychotic, addictive, or major cognitive disorders.
- Severe coronary artery disease (Canadian Cardiovascular Society class III or greater).
- Significant congestive heart failure (New York Heart Association class III or greater).
- Severe thrombocytopenia (platelets <10) - ok if transfused platelets prior to exercise.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prehabilitation Prehabilitation -
- Primary Outcome Measures
Name Time Method Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance 6-9 months Review participant attendance/participation in the program and the questionnaires.
- Secondary Outcome Measures
Name Time Method Amount of Physical Activity Measured With Activity Tracker 6-9 months Quantity of physical activity, measured in hours.
Exercise Behaviour Measured with Modified Godin Leisure Time Exercise Questionnaire 6-9 months Self reported measure of physical activity. Higher scores are better.
Patient Quality of Life Measured with the Functional Assessment of Cancer Therapy-Bone Marrow Transplant and EuroQol 5 Dimension 5 Level Questionnaire 6-9 months Self reported physical, emotional and functional well-being.
Level of Fatigue Measured with the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) Questionnaire 6-9 months Self reported level of fatigue during daily activities. Lower scores mean less fatigue.
Amount of Anxiety and depression Measured with the Hospital Anxiety and Depression Scale (HADS) Questionnaire 6-9 months Self reported level of anxiety and depression. Higher scores indicate more anxiety and depression.
Amount of Symptom burden Measured with the Edmonton Symptom Assessment System-revised (ESAS-r) Questionnaire 6-9 months Self reported symptoms. Higher scores indicate more symptoms.
Patient's Performance Status Measured by the Eastern Cooperative Oncology Group (ECOG) Scale 6-9 months Objective score of patient's level of functioning. Lower scores indicate better functioning.
Handgrip Strength Measured by Handgrip Dynamometry 6-9 months Maximum isometric strength of the hand and forearm muscles.
Balance Measured by Single Leg Stance Test 6-9 months Static postural and balance control, measured in seconds.
Lower Limb Muscular Endurance Measured with 30-second sit-to-stand Test 6-9 months Tests leg strength and endurance, measured in number of stands in 30 seconds.