Clinical trial NCT02893163: CHANGE Cancer Alberta: A Primary Care Program for Cancer Prevention and Screening
Official title: CHANGE (Canadian Health Advanced by Nutrition and Graded Exercise) Cancer Alberta: A Primary Care Program for Cancer Prevention and Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Risk Factors
Keywords: Metabolic Syndrome
Cancer Risk
Lifestyle Interventions
Primary Care
Behavioural Change
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Alberta Innovates Health Solutions
name: Alberta Pulse Growers
name: Alberta Health services
name: Metabolic Syndrome Canada
First posted: 2016-09-08
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

1. Adult patients (18+);
2. Adjusted BMI 26-40. This is a BMI calculated with the measured body weight minus 5 kg to reflect potential shifts in fluid balance;
3. 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.
4. Have Metabolic Syndrome (MetS is defined as having 3 of the 5 following criteria):

   1. Fasting Blood Glucose \> 5.6 mmol/L or receiving pharmacotherapy;
   2. Blood Pressure of \> 130/85 mm Hg or receiving pharmacotherapy;
   3. Triglyceride of \> 1.7 mmol/L or receiving pharmacotherapy;
   4. HDL-C \< 1.0 mmol/L Males and \<1.3 mmol/L females;
   5. Increased Abdominal Circumference as per protocol.
5. Patients identified at risk for cancer due to diet and physical activity behaviours:

   a. 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%.

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Exclusion Criteria:

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

Patient Level: Exclusion criteria: These include:

1. 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.
2. Unable to speak, read or understand English.
3. Have a medical or physical condition that makes moderate intensity activity difficult or unsafe.
4. Diagnosis of Type 1 diabetes mellitus.
5. 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
6. Significant medical comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), heart disease, stroke and ongoing substance abuse.
7. Clinically significant renal failure.
8. Diagnosis of cancer (other than non-melanoma skin cancer) that is currently being treated with radiation or chemotherapy.
9. Diagnosis of psychiatric disorders (cognitive impairment) that would limit adequate informed consent or ability to comply with study protocol.
10. Diagnosis of a terminal illness and/or in hospice care.
11. Pregnancy, lactating or planning to become pregnant during the study period.
12. 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.
13. Chronic inflammatory diseases. This includes clinically active inflammatory diseases such as clinically active ulcerative colitis, Crohn's disease or collagen vascular disease.
14. Patients currently attending an intensive lifestyle intervention (i.e. diabetes program, hypertension lipid clinic)

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Primary outcomes:
measure: Primary Cancer Risk Outcome - Physical Activity
timeFrame: Baseline, 12 months
measure: Primary Cancer Risk Outcome - Nutrition
timeFrame: Baseline, 3 months. 12 months, 18 months
measure: Primary Metabolic Syndrome Outcomes
timeFrame: Baseline, 3 months, 12 months, 18 months
Secondary outcomes:
measure: Secondary Cancer Risk Outcome - BMI
timeFrame: Baseline, 3 months, 12 months, 18 months
measure: Secondary Caner Risk Outcome - Waist Circumference
timeFrame: Baseline, 3 months, 12 months, 18 months
measure: Secondary Metabolic Syndrome Outcome - Cardiovascular Risk
timeFrame: Baseline, 3 months, 12 months, 18 months
Other outcomes:
measure: Patient Self Reported Health
timeFrame: Baseline, 3 months, 12 months, 18 months
measure: Patient Self Reported Quality of Life
timeFrame: Baseline, 3 months, 12 months, 18 months
Locations:
Study officials:
affiliation: University of Alberta
name: Doug Klein, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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