CHANGE Cancer Alberta: A Primary Care Program for Cancer Prevention and Screening (CHANGECaAB)
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|ClinicalTrials.gov Identifier: NCT02893163|
Recruitment Status : Enrolling by invitation
First Posted : September 8, 2016
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Risk Factors||Behavioral: CHANGE Intervention Other: Usual Care||Not Applicable|
The study is a cluster randomized control trial of 16 Primary Care Networks (PCN) in Alberta. Inclusion and exclusion criteria will occur at both the cluster and the patient levels. Site criteria have been designed to ensure implementation of the intervention is possible while contamination to the control sites is minimized. Patient level criteria are designed to include as many patients with Metabolic Syndrome identified at risk for cancer due to diet and physical activity behaviours as possible, maximizing generalizability, while ensuring that patients recruited are safely able to follow the CHANGE intervention.
CHANGE intervention utilizes a novel approach of embedding the expertise of Dietitians (RD) and Exercise Specialists (ES) with a patient's own Family Doctor (FD) to support a personalized nutrition and exercise intervention for patients with Metabolic Syndrome identified at risk for cancer due to diet and physical activity behaviours that is feasible to implement across diverse practice settings. There is sufficient data to support that the individual components of lifestyle interventions (diet and exercise) are efficacious. Unfortunately, primary care currently has limited capacity to implement lifestyle interventions to manage individuals who are overweight or obese. Family Doctors experience various barriers to providing diet and exercise counseling, including lack of staff and resources, limited time for effective health promotion counseling and limited specialized training. In order to provide quality of care for patients with Metabolic Syndrome identified at risk for cancer due to diet and physical activity behaviours, the investigators need to reduce these barriers and support Family Doctors with health care professionals who have the skills and time to help patients change their behaviours.
Although access to interdisciplinary teams has increased in Alberta over the past few years through the development of Primary Care Networks, the optimal composition of these teams has not yet been determined. There is significant evidence to support increased diet and exercise professionals within these primary care teams. Currently, Primary Care Networks are making decisions on how to structure the health care team for their networks. This recent development and strong provincial organizational structure creates a unique time and location to conduct a trial examining the prevention activities of health care teams. Findings from the CHANGE Cancer Alberta Study will inform Primary Care Network business plans to support the implementation of the CHANGE intervention broadly across Alberta.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CHANGE (Canadian Health Advanced by Nutrition and Graded Exercise) Cancer Alberta: A Primary Care Program for Cancer Prevention and Screening|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: CHANGE Intervention
The CHANGE intervention is a personalized approach to nutrition and exercise modification supported by a interdisciplinary team. The FD will recruit patients, complete baseline measurements and stabilize medication. The RD will create a diet plan tailored to the individual patient based on the intervention protocol. The ES will create an exercise plan tailored to the individual patient based on the intervention protocol. At the start, patients will meet weekly with the RD and ES in order to monitor progress, ascertain barriers and facilitators to change, and ensure adherence for the first 12 weeks of the intervention. Meetings will then occur monthly for the remaining 9 months of the intervention. Visits with the FD will occur every 3 months for the 12 month intervention to monitor progress, encourage behaviour change. A follow-up visit with the Research Coordinator will take place at 18 months.
Behavioral: CHANGE Intervention
Canadian Health Advanced by Nutrition and Graded Exercise Protocol
Active Comparator: Usual Care
The usual care arm of the study will involve regular care from the patients' FD. This may involve discussions regarding nutrition and exercise. The FD will still recruit patients, complete baseline measurements and stabilize medication. Visits to the FD will occur as usual care dictates. Participating PCNs randomized to usual care will still have interdisciplinary team members available but the referral arrangements are and will continue to be ad hoc. For the study, we will mandate that control patients have follow-up with the Research Coordinator at 3, 12 and 18 months for the purpose of assessing outcomes. At these time points, appointments will not be scheduled with the FD to manage their disease; rather, the purpose of the visit is to just conduct the outcome assessment.
Other: Usual Care
Usual Care by Family Doctor
- Primary Cancer Risk Outcome - Physical Activity [ Time Frame: Baseline, 12 months ]Proportion of patients with improved physical activity levels (step counts) measured by 7-day accelerometer step count
- Primary Cancer Risk Outcome - Nutrition [ Time Frame: Baseline, 3 months. 12 months, 18 months ]Proportion of patients with improved eating behaviours (Healthy Eating Index) as measured by 2-24 hour dietary recalls
- Primary Metabolic Syndrome Outcomes [ Time Frame: Baseline, 3 months, 12 months, 18 months ]Proportion of patients achieving reversal of Metabolic Syndrome (no longer meeting 3 of 5 diagnostic criteria
- Secondary Cancer Risk Outcome - BMI [ Time Frame: Baseline, 3 months, 12 months, 18 months ]Proportion of patients achieving reduction in BMI
- Secondary Caner Risk Outcome - Waist Circumference [ Time Frame: Baseline, 3 months, 12 months, 18 months ]Proportion of patients achieving reduction in waist circumference
- Secondary Metabolic Syndrome Outcome - Cardiovascular Risk [ Time Frame: Baseline, 3 months, 12 months, 18 months ]Proportion of patients achieving reduction in 10-year cardiovascular risk (as calculated by the PROCAM (Prospective Cardiovascular Munster Study) risk algorithm)
- Patient Self Reported Health [ Time Frame: Baseline, 3 months, 12 months, 18 months ]Proportion of patients improving self-reported health (using the short-form-12 [SF-12 (Short Form-12) Health Scale Scoring]
- Patient Self Reported Quality of Life [ Time Frame: Baseline, 3 months, 12 months, 18 months ]Proportion of patients improving self-reported quality of life (using EQ-5D-5L (EuroQol-5 Dimension-5 Level))
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): NCT02893163
|Principal Investigator:||Doug Klein, MD, MSc||University of Alberta|