Cancer Rehab Program for Allogenic Bone and Marrow Transplant Patients - CaRE-4-alloBMT

NCT04966156 | Completed

• 1 other identifier: 21-5076.0
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, transplantation centers across North America generally do not offer longitudinal rehabilitation programs and research is urgently needed to test the acceptability and effectiveness of these programs using innovative delivery strategies that have the potential for future scalability and to understand the associated costs. Through a strong collaboration between the PM Cancer Rehabilitation and Survivorship (CRS) and alloBMT teams, the principal investigators developed an innovative multicomponent rehabilitation intervention for patients undergoing alloBMT (CaRE-4-alloBMT). CaRE-4-alloBMT uses a person- centred strategy and a multidimensional approach targeting physical activity, nutrition, psychosocial distress and promoting self-management skills. Innovative components of CaRE-4-alloBMT include:1) Individualized progressive exercise prescriptions developed and monitored by CRS registered kinesiologists and supported with a web/mobile application (Physitrack) that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials; 2) Individualized nutrition plans and stepped stratified care (education, counselling, intervention) based on nutritional status and delivered by registered dietitians (alloBMT and CRS). 3) On-line e-modules (developed in collaboration with PM Oncology Education) provide interactive education to promote self-management skills on crucial topics; 4) Remote monitoring using FitbitTM devices to monitor patients physical activity, caloric intake, and sleep for duration of the program; 5) Remote clinical support: Pre/Post discharge, patients will have scheduled (PHS) remote check-ins and health coaching sessions with a member of the CRS team (phone or MS Teams video). Objectives: i) To test the feasibility and safety of CaRE-4-alloBMT plus standard best practice cancer care compared to standard best practice cancer care alone; ii) To assess the preliminary efficacy of CaRE-4-alloBMT on physical function, disability, nutritional status, distress, QoL, healthcare utilization, and survival and estimate program return on investment.

Conditions

Allogeneic Disease; Hematologic Cancer; Cancer Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Drop-out rates as a measure of feasibility

  Number of patients who complete the study/ drop-out will be used to identify feasibility of the intervenion.

  6 months

• Patient preference as assessed during clinical support as a measure of feasibiity

  Check-ins with health coach during assessments will be used to identify intervention acceptability/preference.

  6 months

• Measuring safety as assessed during one-on-one interviews with health coach - this wll be (analyzed as qualitative data) done over MS Teams and will be a conversational question and answer format.

  Patients will be checking-in at specific timepoints with a health coach to discuss their preference/challenges with intervention.

  6 months

Secondary Outcomes (13)

• Disability assessment schedule

  6 months

• 36 items short form health survey

  6 months

• Evaluating nutritional status based on caloric intake

  6 months

• Using the Body Mass Indext to measure nutritional status

  6 months

• Measure of nutritional status by using the Patient Generated Subjective Global Assessment

  6 months

Study Arms (2)

Usual care group

NO INTERVENTION

No change to patient's usual care at Princess Margaret Cancer Centre.

CaRE-4-allBMT plus usual care

EXPERIMENTAL

a longitudinal 6-month rehabilitation program that uses a person- centred strategy and a multidimensional approach targeting physical activity, nutrition, psychosocial distress and promoting self-management skills.

Behavioral: CaRE-4-alloBMT plus usual care group

Interventions

CaRE-4-alloBMT plus usual care group BEHAVIORAL

CaRE-4-alloBMT uses emerging eHealth technologies to reduce barriers to accessing and providing cancer rehabilitation which includes: 1) Individualized progressive exercise prescriptions that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials; 2) Individualized nutrition plans and stepped stratified care such as education, counselling, intervention based on nutritional status and delivered by registered dietitians; 3) On-line e-modules provide interactive education to promote self-management skills for stress management, nutrition, managing common symptoms, etc.; 4) Remote monitoring using FitbitTM devices to monitor patients physical activity, caloric intake, and sleep for duration of the program. CRS and alloBMT clinicians will have access to real-time Fitbit data through our clinical dashboard; 5) Remote clinical support: check-ins and health coaching sessions with a member of the CRS team (phone or MS Teams video).

CaRE-4-allBMT plus usual care

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Must have received a hematologic cancer diagnosis
• Awaiting alloBMT
• Able to communicate in English
• Able to access online study material (Physitrack and education e-modules).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location

Related Publications (1)

• Tam S, Alibhai SMH, Hassanieh D, Kumar R, Mattsson J, Atenafu EG, Avery L, Bernstein LJ, Chang E, Langelier D, Lopez P, Jones JM. A phase 2 study of a longitudinal multidimensional rehabilitation program for allogeneic blood and marrow transplantation patients. Blood Adv. 2024 Sep 24;8(18):4778-4791. doi: 10.1182/bloodadvances.2024012968.

  PMID: 38985303 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jennifer M Jones, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: biostatician will provide the randomized grouping for each of the participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be informed when consented that they will be grouped into one of two (control or intervenion) study groups for the duration of the study. Following their baseline assessment, patients will be randomized (1:1 stratified by age and clinical frailty score at pre-transplant consultation).

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: July 19, 2021
• Study Start: September 8, 2021
• Primary Completion: November 30, 2022
• Study Completion: January 31, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)