CHANGECaAB: CHANGE Cancer Alberta: A Primary Care Program for Cancer Prevention and Screening

Sponsor

University of Alberta (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02893163

Collaborator

Canadian Institutes of Health Research (CIHR) (Other), Alberta Innovates Health Solutions (Other), Alberta Pulse Growers (Other), Alberta Health services (Other), Metabolic Syndrome Canada (Other)

750

Enrollment

Arms

78.9

Duration (Months)

Study Details

Study Description

Brief Summary

The primary purpose of this trial will be to test the effectiveness of CHANGE intervention to increase physical activity, improve diets, reduce obesity and reverse Metabolic Syndrome among adult patients identified as at risk for cancer due to diet and physical activity behaviours when implemented in typical primary care settings within the Alberta context.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Risk Factors	Behavioral: CHANGE Intervention Other: Usual Care	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

750 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Aug 1, 2016

Actual Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Primary Cancer Risk Outcome - Physical Activity [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 [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 [Baseline, 3 months, 12 months, 18 months]
Proportion of patients achieving reversal of Metabolic Syndrome (no longer meeting 3 of 5 diagnostic criteria

Secondary Outcome Measures

Secondary Cancer Risk Outcome - BMI [Baseline, 3 months, 12 months, 18 months]
Proportion of patients achieving reduction in BMI
Secondary Caner Risk Outcome - Waist Circumference [Baseline, 3 months, 12 months, 18 months]
Proportion of patients achieving reduction in waist circumference
Secondary Metabolic Syndrome Outcome - Cardiovascular Risk [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)

Other Outcome Measures

Patient Self Reported Health [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 [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))

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cluster level: Inclusion criteria: These include: 1) PCN within Alberta, 2) ability to incorporate RDs and ESs into the health care team.

Patient level: Inclusion criteria:

Adult patients (18+);
Adjusted BMI 26-40. This is a BMI calculated with the measured body weight minus 5 kg to reflect potential shifts in fluid balance;
Edmonton Obesity Stage 1 or 2(62). • Stage 1 patients have obesity-related subclinical risk factor(s) (e.g., borderline hypertension, impaired fasting glucose, elevated liver enzymes, Etc.), mild physical symptoms (e.g., dyspnea on moderate exertion, occasional aches and pains, fatigue, etc.), mild psychopathology, mild functional limitations and/or mild impairment of well being.

• Stage 2 patients have established obesity-related chronic disease(s) (e.g., hypertension, type 2 diabetes, sleep apnea, osteoarthritis, reflux disease, polycystic ovary syndrome, anxiety disorder, etc.), moderate limitations in activities of daily living and/or well being.

Have Metabolic Syndrome (MetS is defined as having 3 of the 5 following criteria):
Fasting Blood Glucose > 5.6 mmol/L or receiving pharmacotherapy;
Blood Pressure of > 130/85 mm Hg or receiving pharmacotherapy;
Triglyceride of > 1.7 mmol/L or receiving pharmacotherapy;
HDL-C < 1.0 mmol/L Males and <1.3 mmol/L females;
Increased Abdominal Circumference as per protocol.
Patients identified at risk for cancer due to diet and physical activity behaviours:

Physical inactivity measured by: i. less than 150 minutes of moderate activity (i.e., brisk walking, bike riding, jogging) per week and/or strength trains less than 2 times weekly] OR ii. high sedentary time (>11 hours per day 1,2 ) AND b. Dietary behaviour risk measured by: i. Diabetes risk score of high or very high or fasting glucose or Hgb A1c above normal OR ii. Abnormal fasting plasma lipid profile AND c. 10-Year cardiovascular risk score >10%.

Exclusion Criteria:

Cluster level: Exclusion criteria: Previous involvement of the CHANGE intervention.

Patient Level: Exclusion criteria: These include:

Edmonton Obesity Stage 0, 3, or 4(62).

• Stage 0 patients have no apparent obesity-related risk factors, no physical symptoms, no psychopathology, no functional limitations and/or impairment of well being. They do not require intensive lifestyle interventions.

• Stage 3 patients have established end-organ damage such as myocardial infarction, heart failure, diabetic complications, incapacitating osteoarthritis, significant psychopathology, significant functional limitation(s) and/or impairment of well being. This person requires intensive obesity treatment including pharmacological and surgical treatment options.

• Stage 4 patients have severe (potentially end-stage) disability/ies from obesity-related chronic diseases, severe disabling psychopathology, severe functional limitation(s) and/or severe impairment of well being. Aggressive obesity management is required if feasible that includes palliative measures such as pain management, occupational therapy and psychosocial support.

Unable to speak, read or understand English.
Have a medical or physical condition that makes moderate intensity activity difficult or unsafe.
Diagnosis of Type 1 diabetes mellitus.
Type 2 diabetes only if any of the following are present

o Proliferative diabetic retinopathy

o Nephropathy (serum creatinine > 160 μmol/L)

Clinically manifest neuropathy defined as absent ankle jerks
Severe fasting hyperglycemia > 11 mmol/L
Peripheral vascular disease

Significant medical comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), heart disease, stroke and ongoing substance abuse.
Clinically significant renal failure.
Diagnosis of cancer (other than non-melanoma skin cancer) that is currently being treated with radiation or chemotherapy.
Diagnosis of psychiatric disorders (cognitive impairment) that would limit adequate informed consent or ability to comply with study protocol.
Diagnosis of a terminal illness and/or in hospice care.
Pregnancy, lactating or planning to become pregnant during the study period.
Investigator discretion for clinical safety or protocol adherence reasons. This is based on the doctor's judgement. Patients whom the doctor believes will not be responsive to the intervention should be excluded.
Chronic inflammatory diseases. This includes clinically active inflammatory diseases such as clinically active ulcerative colitis, Crohn's disease or collagen vascular disease.
Patients currently attending an intensive lifestyle intervention (i.e. diabetes program, hypertension lipid clinic)