Rehab Study for alloBMT Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJennifer Jones
About this trial
The goals of this phase III clinical trial is to determine effectiveness in the setting where it will be implemented as well as to gain an understanding of the context for implementation. Effectiveness of CaRE-4-alloBMT will be assessed using a parallel two-arm pragmatic randomized controlled trial (pRCT). Pragmatic trials are undertaken in "real world" settings and place a greater emphasis on external validity and generalizability to support the decision on whether to deliver an intervention.
Participants will:
* Complete a questionnaire package and an initial assessment with a registered Kinesilogist * Randomized into either the CaRE-4-alloBMT (Intervention group) or the Usual Care group. * Complete the patient reported outcome measures and physiological assessments at baseline (T0), hospital admission (T1), hospital discharge (T2), 3-months post-discharge (T3), and 6 months post-discharge (T4).
Usual Care (UC). The UC group will receive standard cancer care provided to all patients undergoing alloBMT at Princeess Margaret, including the provision of self-directed online resources and a booklet-based physiotherapy program outlining the role of exercise and examples of exercises that can be done at the hospital and at home during recovery. At admission, patients undergo a nutrition assessment by the alloBMT dietician and are provided a caloric intake goal. They are asked to track their food intake through a food journal that is monitored by the alloBMT dietitian. When needed, as determined by the alloBMT team, patients are given access to supportive care services including psychosocial oncology and in-patient and outpatient rehabilitation.
CaRE-4-alloBMT (Intervention, INT): Patients randomized to the intervention arm will receive usual care plus the CaRE-4-alloBMT intervention. The CaRE-4-alloBMT program is delivered from 4-8 weeks pre-transplant through to 6 months post-transplant (estimated at 8-9 months total). It uses a person-centered strategy and a multidimensional approach targeting physical activity and promoting self-management skills to enhance nutrition, psychosocial functioning and to help manage common side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
> 18 years of age;
receiving treatment for a hematologic cancer;
completing pre- and post-transplant care at PM;
able to access on-line study material; and
Disqualifiers
scheduled to be admitted to the hospital for their alloBMT < 2 weeks from the initial assessment booking, as this will not allow enough time for the prehabilitation phase of the study;
are participating in any other clinical trials or supportive care intervention studies; or
have comorbidities or musculoskeletal complications that preclude participation in the exercise programs.
Trial design
Design model
Parallel
Treatments tested in this trial
CaRE-4-alloBMT
BehavioralThe program is informed by established behaviour change theory, including motivational interviewing (MI), theory of planned behaviour, self-efficacy, and the model of supportive accountability, and has a number of embedded behaviour change techniques, which are known to increase effectiveness. The program also harnesses current and emerging eHealth technologies to overcome barriers to accessing and providing cancer rehabilitation. Key components of the intervention are: 1) Individualized progressive exercise prescriptions; 2) Remote monitoring of heart rate, sleep and weight with Fitbit devices; 3) Self-management skills teaching (online modules on topics such as exercise, eat and cook for wellness, mindfulness, fatigue, brain health, etc); 4) Person-to-person clinical support (remote check-in calls with a kinesiologist)
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: CaRE-4-alloBMT intervention armExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
36-Item Short Form Health Survey questionnaire (SF-36)
The SF-36 is a measure of health status and consists of 36 questions that cover eight health domains and two summary scales: the physical component summary (PSC) and the mental component (MSC). For this project the PCS was chosen as the primary outcome. The minimum score value is a zero and represents the lowest level of health, maximum disability or severe pain. The maximum score is 100 and represents the highest value of health, no disability or no pain.
Time frame
3 months post-dischargeSecondary outcomes
1
Initial hospital stay Transplant outcomes
Initial length of stay will be measured in days and will extracted from patient charts at the end of the study.
Time frame
Year 42
Number of readmission Transplant outcomes
The number of readmissions per patient who underwent alloBMT and participating in the study will extracted from patient charts at the end of the study.
Time frame
Year 43
Number of days in hospital Transplant outcomes
The total number of days spent in the hospital by patients who underwent alloBMT and participating in the study will extracted from patient charts at the end of the study.
Time frame
Year 44
Overall survival Transplant outcomes
Overall survival (transplant-related mortality vs survival rates) patients who underwent alloBMT and participating in the study will extracted from patient charts at the end of the study.
Time frame
At year 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jennifer Jones
Lead sponsor
University Health Network, Toronto
Sponsor institution
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov