NCT Number: NCT07457866
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G 2M9, Canada
Location status: Recruiting
Charmaine Silva, MSc
CONTACT
Jennifer Jones, PhD
CONTACT
Jennifer M Jones, PhD
PRINCIPAL_INVESTIGATOR
Rajat Kumar, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The 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)
Time frame: 3 months post-discharge
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: Year 4
Initial length of stay will be measured in days and will extracted from patient charts at the end of the study.
Time frame: Year 4
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 4
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: At year 4
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: 9 months
The instrument is a standardized descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each evaluated through a single item and measures quality of life. The maximum score of 1 represents having no problems in any of the 5 dimensions and best health while a minimum score of a negative value indicates worse health.
Time frame: 9 months
The instrument is a one-page tool that classifies patients into four nutritional levels, which are predictive of overall survival in cancer patients and measures nutritional status.
Time frame: 9 months
This instrument includes 2 subscales designed to identify and quantify depression and anxiety in physically ill patients. The minimum score of zero and a maximum score of 21 where a higher score indicates higher distress.
Time frame: 9 months
The instrument measures disability in accordance with the International Classification of Functioning, Disability, and Health. Participants rate their ability to perform 12 activities across six domains of functioning. A minimum score of zero indicates no disability and a maximum score of 48 indicates full disability.
Time frame: A one-time questionnaire to be completed at baseline/prior to initial assessment.
Demographic and clinical details will be collected from participants at the time of initial assessment via an intake questionnaire, including age, sex, gender, ethnicity, education level, socioeconomic status, and comorbidities.
Contact information is provided by the study sponsor or research team.
Charmaine A Silva, MSc
CONTACT
Jennifer M Jones, PhD
CONTACT
Jennifer Jones
Other
A Type 1 Hybrid Effectiveness Implementation Trial of a Longitudinal Multidimensional Rehabilitation Program for Patients Undergoing Allogeneic Blood and Marrow Transplantation (CaRE4alloBMT)
Acronym: CaRE-4-alloBMT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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