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Recruiting NCT06280924

Prehab Prior to Stem Cell Transplantation in Multiple Myeloma

No phase Interventional Multiple Myeloma Exercise Prehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supported Exercise, Standard Care.
Who it may be relevant to
Registry conditions: Multiple Myeloma, Exercise, Prehabilitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Supported Exercise
    Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant.
  • Behavioral Standard Care
    Participants will receive standard care

Primary outcome measures

  • Study completion rate [Time frame: 10-weeks]
Secondary outcome measures (12)
  • Recruitment rate [Time frame: 18 months]
  • Attendance rate [Time frame: 18 months]
  • Edmonton Symptom Assessment System [Time frame: 10 weeks]
  • Functional Assessment of Cancer Therapy Multiple Myeloma [Time frame: 10 weeks]
  • Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item) [Time frame: 10 weeks]
  • Body weight [Time frame: 10 weeks]
  • Body height [Time frame: 10 weeks]
  • Grip Strength [Time frame: 10 weeks]
  • Calf muscle size [Time frame: 10 weeks]
  • Thigh muscle thickness [Time frame: 10 weeks]
  • Short Physical Performance Battery [Time frame: 10 weeks]
  • Six-minute walk test [Time frame: 10 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Canada · 1 center
  • University of Alberta/ Cross Cancer Institute — Edmonton

Identifiers

NCT: NCT06280924 · HREBA.CC-23-0220

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗