Prehab Prior to Stem Cell Transplantation in Multiple Myeloma

NCT06280924 | Recruiting

• 1 other identifier: HREBA.CC-23-0220
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Exercise; Prehabilitation

Outcome Measures

Primary Outcomes (1)

• Study completion rate

  The percentage of participants who complete the study, including the intervention and follow-up assessment

  10-weeks

Secondary Outcomes (15)

• Recruitment rate

  18 months

• Attendance rate

  18 months

• Edmonton Symptom Assessment System

  10 weeks

• Functional Assessment of Cancer Therapy Multiple Myeloma

  10 weeks

• Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item)

  10 weeks

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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

Supported Exercise Group

EXPERIMENTAL

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

Interventions

Supported Exercise BEHAVIORAL

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

Supported Exercise Group

Standard Care BEHAVIORAL

Participants will receive standard care

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of Multiple Myeloma
• Be transplant eligible
• Be undergoing chemotherapy prior to, or following an autologous stem cell transplant as part of their cancer treatment; or transplant ineligible.
• Be an Alberta resident
• Be ≥18 years of age
• Be able to read and understand English.

You may not qualify if:

• Their disease status/comorbidities preclude exercise testing or participation
• 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
• They do not have regular access to the internet and/or an electronic device in the home.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Chris Sellar, PhD

  University of Alberta

  STUDY DIRECTOR

Central Study Contacts

Margaret L McNeely, PhD

CONTACT

7802890972; mmcneely@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent assessor will conduct the post-intervention assessment. The independent assessor will be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: August 6, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be deposited approximately one-year after completion of the study
• Access Criteria: Open access

Locations

CA (1)