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

NCT ID: NCT04966156

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-08
• Study Completion Date: 2023-01-31

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.

Detailed Description

1.0 BACKGROUND: Allogeneic blood and marrow transplantation (alloBMT) is a curative treatment for many hematologic cancers and its use has increased rapidly over the past decade. While effective, alloBMT is associated with numerous treatment-related physical and psychosocial side effects, reduced physical functioning, and worsening nutritional status which are associated with increased risk of complications (i.e. infections, drug toxicity, weight loss, graft failure & graft-versus-host disease), significant early and late treatment related mortality, and can profoundly affect quality of life (QoL).

As a result, there have been calls for increased attention to the management of adverse effects associated with alloBMT with the goal to minimize dysfunction, maximize well-being and QoL, and reduce treatment-related mortality.

Cancer rehabilitation is now considered an essential component of cancer care and focuses on prevention and treatment of the adverse effects of cancer and treatment and to optimize functional status and QoL. Embedding multidimensional longitudinal (pre to post transplant) rehabilitation programs that focus on exercise, nutrition and teaching self-management skills as a standard part of treatment for individuals undergoing alloBMT has potential to mediate the significant adverse effects, improve survival, and reduce burden on the healthcare system. While patients typically receive some in-patient rehabilitation, this is a small part of the alloBMT pathway and services are quite limited. 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. In response, 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).

2.0 PROGRAM DESCRIPTION (see Appendix 1): CaRE-4-alloBMT is a longitudinal 6-month rehabilitation program (peri to post transplant) adapted from an existing evidence-based and effective model developed by the CRS team (CaRE@ELLICSR and CaRE@Home). The program is informed by established behaviour change theory and harnesses current and emerging eHealth technologies to reduce barriers to accessing and providing cancer rehabilitation. 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. The initial personalized exercise program will be given to a participant following the initial assessment. A program will be created based on the specific needs and physical condition of each participant. The participant will receive the detailed exercise program via Physitrack (includes exercise description and videos of each exercise). Each exercise program will contain cardiovascular and strength training as well as stretching exercises. The exercise program will be revised and progressions will be added based on the individual's needs after the follow-up assessments or during the scheduled check-ins between assessments. Check-ins are scheduled as follows:

• At 2 and 4 weeks after initial assessment
• 8 weekly check-ins following discharge
• At 10 and 12 weeks following discharge The participant can contact the Kinesiologist by e-mail at any point during the program.

2. Individualized nutrition plans and stepped stratified care (education, counselling, intervention) based on nutritional status and delivered by registered dietitians (alloBMT and CRS). As part of standard of care, all patients receive a nutrition assessment and their caloric intake goals are set. Those in the INT arm (CaRE-4-alloBMT plus usual care group) will receive additional nutritional education through the e-modules and monitoring of caloric intake through the Fitbit. They will also have access to meal preparation and recipes through ellicsrkitche.ca. Patients can track their nutritional intake on their Fitbit device and this data will be monitored weekly by the RKin. Patients who falls below 50% of their goals (based on intake assessment) will flagged to the RD for follow up.

3. On-line e-modules (developed in collaboration with PM Oncology Education) provide interactive education to promote self-management skills on crucial topics (i.e. stress management, nutrition, managing common symptoms). There will be 9 online e-modules:

• Introduction: Getting started
• Eat and Cook for Wellness
• Exercise
• Manage Your Emotions
• Reduce Fatigue
• Being Mindful
• Boost Your Brain Health
• Stay Connected
• Planning for the Future Participants will be asked to complete all 9 modules. Each module should take between 20-30 minutes to complete. Participants can go through these modules at their own pace. Patients will receive a link for the online modules. Patients will be able to access the module by entering their e-mail address and creating their own unique password.

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 the clinical dashboard (developed in collaboration with TECHNA). The Fitbit is also known to promote behaviours change and allows for self-monitoring and feedback. Participants will be asked to wear the Fitbit for the duration of the study. Participants will only need to add their meals to monitor their nutrition. No other action is required from the participants once the account has been created. This will replace the paper based food diary they must keep (standard of care). The account for the participant will be created by the RA or RKin and the participant will then be able to access the app via an email link. The RA or RKin can assist/provide support to the participant as needed to access the app. If the participant is unable to download or use the app a detailed print out of their exercise program will be provided.

The following information will be required to create an account:

• First name
• Last name (participant study number will be entered in this field
• Year of birth
• Email address Both the participant and Kinesiology team will have access to this information but the account information is not visible to third parties. Physitrack provides links to the privacy policy and terms of use/agreement and is available for the participant to review as needed.

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). These occur in week 2,4 (pre) and 1-8,10,12 (post-discharge).

Frequency of check-ins and what will be discussed: Check-ins are by telephone or MSteams video and scheduled as follows:

• At 2 and 4 weeks after initial assessment (pre-BMT admission)
• Weeks 1-8, 10 and 12 post-discharge (post-BMT dischange)

• Check-ins discussion using motivational interviewing techniques and focus on
• Adherence to exercise program
• Changes to exercise program based on participant's needs
• Module completion
• Answering participants questions The program strongly aligns with the SUNDAE framework

Conditions

Allogeneic Disease; Hematologic Cancer; Cancer Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Usual care group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

CaRE-4-allBMT plus usual care

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.

Group Type: EXPERIMENTAL

CaRE-4-alloBMT plus usual care group

Intervention Type: 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).

Interventions

CaRE-4-alloBMT plus usual care group

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer M Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 38985303 (View on PubMed)

Other Identifiers

21-5076.0

Identifier Type: -

Identifier Source: org_study_id