Prehab Prior to Stem Cell Transplantation in Multiple Myeloma

NCT ID: NCT06280924

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-06

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma Exercise Prehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
An independent assessor will conduct the post-intervention assessment. The independent assessor will be blinded to group assignment.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Participants will receive standard care

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.

Group Type EXPERIMENTAL

Supported Exercise

Intervention Type BEHAVIORAL

Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant.

Interventions

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Supported Exercise

Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant.

Intervention Type BEHAVIORAL

Standard Care

Participants will receive standard care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Sellar, PhD

Role: STUDY_DIRECTOR

University of Alberta

Locations

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University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Margaret L McNeely, PhD

Role: CONTACT

7802890972

Facility Contacts

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Margaret McNeely, PhD

Role: primary

780-248-1531

Margaret L. McNeely, PhD

Role: backup

Other Identifiers

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HREBA.CC-23-0220

Identifier Type: -

Identifier Source: org_study_id

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