Clinical trial NCT06280924: Prehab Prior to Stem Cell Transplantation in Multiple Myeloma
Official title: Multiple Myeloma Exercise Prehabilitation for Individuals Awaiting a Stem Cell Transplantation (MOTIVATE): a Randomized Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Exercise
Prehabilitation
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Primary outcomes:
measure: Study completion rate
timeFrame: 10-weeks
Secondary outcomes:
measure: Recruitment rate
timeFrame: 18 months
measure: Attendance rate
timeFrame: 18 months
measure: Edmonton Symptom Assessment System
timeFrame: 10 weeks
measure: Functional Assessment of Cancer Therapy Multiple Myeloma
timeFrame: 10 weeks
measure: Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item)
timeFrame: 10 weeks
measure: Body weight
timeFrame: 10 weeks
measure: Body height
timeFrame: 10 weeks
measure: Grip Strength
timeFrame: 10 weeks
measure: Calf muscle size
timeFrame: 10 weeks
measure: Thigh muscle thickness
timeFrame: 10 weeks
measure: Short Physical Performance Battery
timeFrame: 10 weeks
measure: Six-minute walk test
timeFrame: 10 weeks
measure: One leg stance balance
timeFrame: 10 weeks
measure: Shoulder flexion range of motion
timeFrame: 10 weeks
measure: Sit and reach test
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta/ Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Chris Sellar, PhD
role: STUDY_DIRECTOR
References: