Multiphasic Prehab Allo-HSCT

NCT05649371 | Unknown DMC

• 1 other identifier: ACE-HSCT
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to implement a prehabilitation intervention to enhance recovery for people undergoing allogeneic stem cell transplant for hematologic malignancies. All participants in this study will receive a prehabilation intervention in addition to usual care (no change to their chemotherapy protocols or transplant) and several quality of life and fitness scores will be measured throughout the intervention.

Conditions

Leukemia

Keywords

Prehabilitation; Exercise; Allogeneic Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

• Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance

  Review participant attendance/participation in the program and the questionnaires.

  6-9 months

Secondary Outcomes (10)

• Amount of Physical Activity Measured With Activity Tracker

  6-9 months

• Exercise Behaviour Measured with Modified Godin Leisure Time Exercise Questionnaire

  6-9 months

• Patient Quality of Life Measured with the Functional Assessment of Cancer Therapy-Bone Marrow Transplant and EuroQol 5 Dimension 5 Level Questionnaire

  6-9 months

• Level of Fatigue Measured with the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) Questionnaire

  6-9 months

• Amount of Anxiety and depression Measured with the Hospital Anxiety and Depression Scale (HADS) Questionnaire

  6-9 months

Study Arms (1)

Prehabilitation

EXPERIMENTAL

Other: Prehabilitation

Interventions

Prehabilitation OTHER

A multiphasic exercise prehabilitation program for alloHSCT candidates across each treatment phase, that includes behaviour change support

Prehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, 18 years or older, undergoing an allo-HSCT for acute leukemia.
• Approval to engage in exercise as per screening by the CSEP or ACSM certified CEP and/or clinician
• Ability to provide written informed consent and understand study information.

You may not qualify if:

• Less than 18 years old
• Diagnosed with acute leukemia but not undergoing work-up for allo-HSCT
• Unable to read/communicate in English (i.e., unable to complete experimental procedures such as patient-reported outcomes).
• Neurological or musculoskeletal comorbidity inhibiting exercise.
• Diagnosed psychotic, addictive, or major cognitive disorders.
• Severe coronary artery disease (Canadian Cardiovascular Society class III or greater).
• Significant congestive heart failure (New York Heart Association class III or greater).
• Severe thrombocytopenia (platelets \<10) - ok if transfused platelets prior to exercise.

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Cancer Foundation: collaborator

MeSH Terms

Conditions

Leukemia; Motor Activity

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nicole Culos-Reed, PhD

  Health and Wellness Lab and the Thrive Centre

  STUDY DIRECTOR

Central Study Contacts

Sarah Perry, MD, MSc

CONTACT

403 944 9602; sarah.perry2@ahs.ca

Chad Wagoner, PhD

CONTACT

403-210-8482; chad.wagoner@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid implementation-effectiveness study

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: December 14, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 14, 2022

Record last verified: 2022-10