Prehab Prior to Stem Cell Transplantation in Multiple Myeloma (MOTIVATE)

Multiple Myeloma Exercise Prehabilitation for Individuals Awaiting a Stem Cell Transplantation (MOTIVATE): A Randomized Controlled Feasibility Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma; Exercise; Prehabilitation
• Intervention / Treatment: Behavioral: Standard Care; Behavioral: Supported Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaret L McNeely, PhD; Phone Number: 7802890972; Email: mmcneely@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G4
      • University of Alberta/ Cross Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care; Participants in this group will receive exercise counseling as per standard care for 10-weeks. This will include: (1) counseling on remaining active during chemotherapy; (2) handouts on the benefits of exercise during chemotherapy, exercise behavior change strategies, and how to exercise safely. Participants will be encouraged to remain as physical active as possible. As per American College of Sports Medicine 2019 guidelines, participants will be advised to take part in moderate intensity exercise for a total of 90 minutes per week.	Behavioral: Standard Care; Participants will receive standard care
Experimental: Supported Exercise Group; Participants assigned to the exercise group will take part in a 10-week exercise program delivered in-person and through the HEAL-ME app. The program comprises (1) a minimum of one supervised session (in-person or virtual through a Zoom platform embedded in HEAL-ME), (2) a minimum of one independent exercise workout within the HEAL-ME app, and (3) exercise specific education content as per standard care.	Behavioral: Supported Exercise; Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study completion rate	The percentage of participants who complete the study, including the intervention and follow-up assessment	10-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	The percentage of participants who are eligible and consent to participate in the study.	18 months
Attendance rate	The percentage of group and individual exercise sessions completed over the 10 weeks.	18 months
Edmonton Symptom Assessment System	Tool to assess 11 symptoms related to cancer: higher scores reflect worse symptom burden	10 weeks
Functional Assessment of Cancer Therapy Multiple Myeloma	Health-related quality of life questionnaire: higher scores reflect better quality of life	10 weeks
Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item)	Fatigue questionnaire: higher scores reflect less fatigue	10 weeks
Body weight	Weight measured in kilograms	10 weeks
Body height	Weight measured in centimetres (to nearest 0.5 cm)	10 weeks
Grip Strength	Hand grip measured in kilograms using a dynamometer	10 weeks
Calf muscle size	Calf circumference measured in centimetres to the nearest 0.1 cm	10 weeks
Thigh muscle thickness	Ultrasound measurement of rectus femoris muscle cross-sectional area	10 weeks
Short Physical Performance Battery	Test includes 4-meter timed walk, balance and 5-repetition sit-to-stand	10 weeks
Six-minute walk test	Distance covered in metres (to nearest cm) in 6 minutes (hallway)	10 weeks
One leg stance balance	Time standing on one foot (to a maximum of 45 seconds)	10 weeks
Shoulder flexion range of motion	Upper limb flexibility measured in degrees	10 weeks
Sit and reach test	Lower limb flexibility measured in cms (to nearest 0.5 cm)	10 weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Study Director: Chris Sellar, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: HREBA.CC-23-0220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data generated or analyzed during this study will be available in the University of Alberta Dataserve repository
• IPD Sharing Time Frame: Data will be deposited approximately one-year after completion of the study
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No