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.
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
- Conditions the study is for
- Allogeneic Disease, Hematologic Cancer, Cancer Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- 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.
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:
- 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.
- 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.
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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
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
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)
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
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
Evaluating nutritional status based on caloric intake
using data from fitbit worn by patient to record their daily caloric intake.
Measured: 6 months
Using the Body Mass Indext to measure nutritional status
Body Mass Index
Measured: 6 months
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
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
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
Measure of the level of healthcare utilization by patient
clinic chart details for days in hospital, readmission
Measured: 6 months
measure of overall survival
will be interpretted from the quantitative and qualitative date extracted
Measured: 6 months
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
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
grip strength tests
measures the muscular strength or the maximum force/tension generated by one's forearm muscles
Measured: 6 months
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.
- First posted19 Jul 2021
- Study start8 Sep 2021
- Primary completion30 Nov 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allogeneic DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer M Jones, PhD, Principal investigator, University Health Network, Toronto
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
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Multidimensional Cancer Rehab Program for Patients Undergoing Allogenic Bone and Marrow Transplantation (CaRE-4-alloBMT)
- ClinicalTrials.gov ID
- NCT04966156
- Acronym / sponsor ID
- 21-5076.0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Usual care group | No intervention | –No change to patient's usual care at Princess Margaret Cancer Centre. |
| CaRE-4-allBMT plus usual care | Experimental | Behavioral: CaRE-4-alloBMT plus usual care groupa 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaRE-4-alloBMT plus usual care groupCaRE-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). | Behavioural | CaRE-4-allBMT plus usual care |
Primary outcome
Drop-out rates as a measure of feasibility
Time frame: 6 months
Number of patients who complete the study/ drop-out will be used to identify feasibility of the intervenion.
Patient preference as assessed during clinical support as a measure of feasibiity
Time frame: 6 months
Check-ins with health coach during assessments will be used to identify intervention acceptability/preference.
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.
Time frame: 6 months
Patients will be checking-in at specific timepoints with a health coach to discuss their preference/challenges with intervention.
13 secondary outcomes
Disability assessment schedule
Time frame: 6 months
36 items short form health survey
Time frame: 6 months
Evaluating nutritional status based on caloric intake
Time frame: 6 months
Using the Body Mass Indext to measure nutritional status
Time frame: 6 months
Measure of nutritional status by using the Patient Generated Subjective Global Assessment
Time frame: 6 months
General Anxiety Disorder assessment
Time frame: 6 months
Functional Assessment of Cancer Therapy for Bone Marrow Transplant
Time frame: 6 months
Measure of the level of healthcare utilization by patient
Time frame: 6 months
measure of overall survival
Time frame: 6 months
Euroqol 5D
Time frame: 6 months
6 minute walk test
Time frame: 6 months
grip strength tests
Time frame: 6 months
Sit-to-stand test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 38985303Tam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer M Jones, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
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.