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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04966156
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Allogeneic Disease Hematologic Cancer Cancer Rehabilitation Behavioral: CaRE-4-alloBMT plus usual care group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Masking Description: biostatician will provide the randomized grouping for each of the participants.
Primary Purpose: Supportive Care
Official Title: A Longitudinal Multidimensional Cancer Rehab Program for Patients Undergoing Allogenic Bone and Marrow Transplantation (CaRE-4-alloBMT)
Actual Study Start Date : September 8, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
No Intervention: Usual care group
No change to patient's usual care at Princess Margaret Cancer Centre.
Experimental: 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.
Behavioral: 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).




Primary Outcome Measures :
  1. 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.

  2. 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.

  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. [ Time Frame: 6 months ]
    Patients will be checking-in at specific timepoints with a health coach to discuss their preference/challenges with intervention.


Secondary Outcome Measures :
  1. Disability assessment schedule [ Time Frame: 6 months ]
    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.

  2. 36 items short form health survey [ Time Frame: 6 months ]
    self reported measure of overall health - total score: 0-100 and the higher the score, the better the health state (less disability)

  3. Evaluating nutritional status based on caloric intake [ Time Frame: 6 months ]
    using data from fitbit worn by patient to record their daily caloric intake.

  4. Using the Body Mass Indext to measure nutritional status [ Time Frame: 6 months ]
    Body Mass Index

  5. Measure of nutritional status by using the Patient Generated Subjective Global Assessment [ Time Frame: 6 months ]
    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.

  6. General Anxiety Disorder assessment [ Time Frame: 6 months ]
    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

  7. Functional Assessment of Cancer Therapy for Bone Marrow Transplant [ Time Frame: 6 months ]
    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.

  8. Measure of the level of healthcare utilization by patient [ Time Frame: 6 months ]
    clinic chart details for days in hospital, readmission

  9. measure of overall survival [ Time Frame: 6 months ]
    will be interpretted from the quantitative and qualitative date extracted

  10. Euroqol 5D [ Time Frame: 6 months ]
    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.

  11. 6 minute walk test [ Time Frame: 6 months ]
    measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface

  12. grip strength tests [ Time Frame: 6 months ]
    measures the muscular strength or the maximum force/tension generated by one's forearm muscles

  13. Sit-to-stand test [ Time Frame: 6 months ]
    measurement that assesses functional lower extremity strength in older adults



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Exclusion Criteria:

  • Not meeting the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04966156


Contacts
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Contact: Charmaine A Silva, MSc 4167160582 charmaine.silva@uhn.ca
Contact: Paty Lopez, MSc Paty.Lopez@uhnresearch.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2C1
Contact: Paty Lopez, MSc       paty.lopez@uhnresearch.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Jennifer M Jones, PhD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04966156    
Other Study ID Numbers: 21-5076.0
First Posted: July 19, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases