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Allogeneic DiseaseNCT04966156

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

A study of Allogeneic Disease and Hematologic Cancer, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteCanada
Study dates
8 Sep 2021to 31 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Not meeting the inclusion criteria

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C1

Other trials in Canada

About this study

Official title: A Longitudinal Multidimensional Cancer Rehab Program for Patients Undergoing Allogenic Bone and Marrow Transplantation (CaRE-4-alloBMT)

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.

Read the 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.
  1. 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.
  2. 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.
  1. 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.
  1. 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
Being tested
CaRE-4-alloBMT plus usual care group
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaRE-4-alloBMT plus usual care groupBehavioural

    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).

Study groups in NCT04966156
Study groupRoleWhat they receive
Usual care groupNo interventionNo change to patient's usual care at Princess Margaret Cancer Centre.
CaRE-4-allBMT plus usual careExperimentala 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.
Receives: Behavioral: CaRE-4-alloBMT plus usual care group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

Secondary outcomes (13)
  1. Disability assessment schedule

    World Health Organization Disability Assessment Schedule 2.0. The scale is (0-4) for a total score from 0-48 and the larger the value the worse the outcome.

    Measured: 6 months

  2. 36 items short form health survey

    self reported measure of overall health - total score: 0-100 and the higher the score, the better the health state (less disability)

    Measured: 6 months

  3. Evaluating nutritional status based on caloric intake

    using data from fitbit worn by patient to record their daily caloric intake.

    Measured: 6 months

  4. Using the Body Mass Indext to measure nutritional status

    Body Mass Index

    Measured: 6 months

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

    Patient-reported instrument for assessment of nutrition status in patients with cancer - Typical scores range from 0-35 with a higher score reflecting a greater risk of malnutrition and scores ≥9 indicating a critical need for nutrition intervention and symptom management.

    Measured: 6 months

  6. General Anxiety Disorder assessment

    Measure of General Anxiety and distress - total score: 0-21 and the cut-offs are: 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety

    Measured: 6 months

  7. Functional Assessment of Cancer Therapy for Bone Marrow Transplant

    a measure of quality of life - total score of 0-196 with a higher scores for the scales and subscales indicate better quality of life.

    Measured: 6 months

  8. Measure of the level of healthcare utilization by patient

    clinic chart details for days in hospital, readmission

    Measured: 6 months

  9. measure of overall survival

    will be interpretted from the quantitative and qualitative date extracted

    Measured: 6 months

  10. Euroqol 5D

    Health related quality of life - The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.

    Measured: 6 months

  11. 6 minute walk test

    measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface

    Measured: 6 months

  12. grip strength tests

    measures the muscular strength or the maximum force/tension generated by one's forearm muscles

    Measured: 6 months

  13. Sit-to-stand test

    measurement that assesses functional lower extremity strength in older adults

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2021
  2. Study start8 Sep 2021
  3. Primary completion30 Nov 2022
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04966156
Sponsor's protocol ID
21-5076.0
Status last verified
May 2023
First submitted
26 Apr 2021
Last updated
9 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38985303

Questions about this trial

What is this clinical trial studying?

A study of Allogeneic Disease and Hematologic Cancer, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drop-out rates as a measure of feasibility (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04966156, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

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