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Purpose

This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo Autologous Stem Cell transplantation at UAB. Participants will be randomized into either a prehabilitation program or an attention control group before their transplant. The primary outcomes will be feasibility and secondary outcomes include changes in physical function at the time of transplant and at 12 weeks follow up.

Condition

Eligibility

Eligible Ages
Over 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of Multiple Myeloma - Scheduled for ASCT at UAB within 10 weeks of study enrollment - age at ASCT ≥60y

Exclusion Criteria

  • at high risk for impending pathologic fracture using Mirels score

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
We plan to enroll a total of 30 patients, randomized 1:1 using permuted block algorithm stratified by sex and age (e.g. 60-70, >70y), into intervention arm (home based prehabilitation) vs an attention control (dietary counseling) group.
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Teleprehab 		The participants selected for the teleprehab arm will undergo a supervised 8-week multi-modal exercise program in a telehealth format (using doxy.me, a free telehealth platform) delivered by licensed physical or occupational therapists who have undergone cancer specific rehabilitation training within Select Medical's ReVital® cancer rehabilitation program. Participants will attend teleprehab sessions 2 times per week for a total of 16 sessions.
  • Other: Multi-modal Exercise Regimen
    Participants will undergo a total of 16 sessions over 8 weeks. Each therapy session will comprise of patient education, including facilitated goal planning, promotion of physical activity and safe exercise guideline, followed by 30 minutes of preferred aerobic activity such as walking or biking.
  • Behavioral: Dietary Guidelines
    Participants will be contacted once a week to review dietary recommendations per the 2022 American Cancer Society guidelines for cancer survivors.
Other
Attention Control 		The participants randomized to the attention control arm will not undergo an exercise regimen, but will be contacted by the study staff on the phone once a week..
  • Behavioral: Dietary Guidelines
    Participants will be contacted once a week to review dietary recommendations per the 2022 American Cancer Society guidelines for cancer survivors.

Recruiting Locations

Kirklin Clinic of UAB Hospital
Birmingham, Alabama 35294
Contact:
Landon Martin, BS
205-638-2120
CAREheme@peds.uab.edu

More Details

Status
Recruiting
Sponsor
Noha Mohamed Sharafeldin

Study Contact

Landon Martin, BS
205-638-2120
landoncmartin@uabmc.edu

Detailed Description

This is a pilot randomized trial of older adults 60y and above planned to undergo Autologous Stem Cell Transplant for Multiple Myeloma. Eligible participants will be randomized (like flipping a coin) to one of two study conditions: 1) an 8 week long home-based prehabilitation exercise program delivered using a telehealth format or 2) an 8-week long nutrition counseling (attention control group). Assessments will occur at baseline, post-intervention (during transplant) and at 12-weeks post-transplant. Investigators will assess the feasibility and acceptability of our program as well as preliminary impact of the program on physical functioning during these time-periods.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.