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

University of Alberta

Status: Enrolling

Conditions: Multiple Myeloma; Prehabilitation; Exercise

Treatments: Behavioral: Supported Exercise; Behavioral: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06280924

HREBA.CC-23-0220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have a diagnosis of Multiple Myeloma
2. Be transplant eligible
3. Be undergoing chemotherapy prior to, or following an autologous stem cell transplant as part of their cancer treatment; or transplant ineligible.
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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Care

Supported Exercise Group

Experimental group

Description:

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.

Treatment:

Behavioral: Supported Exercise