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Trial Title:
Prehab Prior to Stem Cell Transplantation in Multiple Myeloma
NCT ID:
NCT06280924
Condition:
Multiple Myeloma
Exercise
Prehabilitation
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled trial
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
An independent assessor will conduct the post-intervention assessment. The independent
assessor will be blinded to group assignment.
Intervention:
Intervention type:
Behavioral
Intervention name:
Supported Exercise
Description:
Participants will take part in a prehabilitation exercise program prior to undergoing a
stem cell transplant.
Arm group label:
Supported Exercise Group
Intervention type:
Behavioral
Intervention name:
Standard Care
Description:
Participants will receive standard care
Arm group label:
Standard Care
Summary:
The primary purpose of this study is to see if individuals with Multiple Myeloma are able
and interested in taking part in a tailored exercise program while undergoing their
chemotherapy prior to a stem cell transplant. We also hope to learn if this type of
program, along with a flexible delivery format (in-person and virtual), helps in
maintaining or improving physical fitness, muscle mass and strength, and quality of life
during chemotherapy.
Detailed description:
MOTIVATE is a multi-methods feasibility randomized trial. We will recruit a minimum of 30
individuals with multiple myeloma who are undergoing chemotherapy prior to a Stem Cell
Transplant. The study will be conducted in two phases:
Phase I: Feasibility Study The aim of this phase is to determine the feasibility and
preliminary effectiveness of a 10-week exercise intervention compared to physical
activity counseling alone.
Phase II: Qualitative Study The aim of this phase is to evaluate the acceptability of the
Healthy Eating Active Living (HEAL-ME) app design, program delivery/design, and perceived
effectiveness of the intervention at the level of the participant.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Have a diagnosis of Multiple Myeloma
2. Be transplant eligible
3. Be undergoing chemotherapy prior to an autologous stem cell transplant as part of
their cancer treatment
4. Be an Alberta resident
5. Be ≥18 years of age
6. Be able to read and understand English.
Exclusion Criteria:
1. Their disease status/comorbidities preclude exercise testing or participation
2. They are unable to commit to the 10-week exercise program and/or testing sessions at
the Cancer Rehabilitation Clinic at the University of Alberta
3. They do not have regular access to the internet and/or an electronic device in the
home.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alberta/ Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 2G4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Margaret McNeely, PhD
Phone:
780-248-1531
Email:
mmcneely@ualberta.ca
Contact backup:
Last name:
Margaret L. McNeely, PhD
Start date:
August 6, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
University of Alberta
Agency class:
Other
Source:
University of Alberta
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06280924
