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

NCT02893163 | Completed

• 1 other identifier: Pro00058125
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome; Risk Factors

Keywords

Metabolic Syndrome; Cancer Risk; Lifestyle Interventions; Primary Care; Behavioural Change

Outcome Measures

Primary Outcomes (3)

• Primary Cancer Risk Outcome - Physical Activity

  Proportion of patients with improved physical activity levels (step counts) measured by 7-day accelerometer step count

  Baseline, 12 months

• Primary Cancer Risk Outcome - Nutrition

  Proportion of patients with improved eating behaviours (Healthy Eating Index) as measured by 2-24 hour dietary recalls

  Baseline, 3 months. 12 months, 18 months

• Primary Metabolic Syndrome Outcomes

  Proportion of patients achieving reversal of Metabolic Syndrome (no longer meeting 3 of 5 diagnostic criteria

  Baseline, 3 months, 12 months, 18 months

Secondary Outcomes (3)

• Secondary Cancer Risk Outcome - BMI

  Baseline, 3 months, 12 months, 18 months

• Secondary Caner Risk Outcome - Waist Circumference

  Baseline, 3 months, 12 months, 18 months

• Secondary Metabolic Syndrome Outcome - Cardiovascular Risk

  Baseline, 3 months, 12 months, 18 months

Other Outcomes (2)

• Patient Self Reported Health

  Baseline, 3 months, 12 months, 18 months

• Patient Self Reported Quality of Life

  Baseline, 3 months, 12 months, 18 months

Study Arms (2)

CHANGE Intervention

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

CHANGE Intervention BEHAVIORAL

Canadian Health Advanced by Nutrition and Graded Exercise Protocol

CHANGE Intervention

Usual Care OTHER

Usual Care by Family Doctor

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Alberta Innovates Health Solutions: collaborator
• Alberta Pulse Growers: collaborator
• Alberta Health services: collaborator
• Metabolic Syndrome Canada: collaborator

Related Publications (13)

• Brauer P, Gorber SC, Shaw E, Singh H, Bell N, Shane ARE, Jaramillo A, Tonelli M; Canadian Task Force on Preventive Health Care. Recommendations for prevention of weight gain and use of behavioural and pharmacologic interventions to manage overweight and obesity in adults in primary care. CMAJ. 2015 Feb 17;187(3):184-195. doi: 10.1503/cmaj.140887. Epub 2015 Jan 26. No abstract available.

  PMID: 25623643 BACKGROUND

• Petrella RJ, Lattanzio CN, Overend TJ. Physical activity counseling and prescription among canadian primary care physicians. Arch Intern Med. 2007 Sep 10;167(16):1774-81. doi: 10.1001/archinte.167.16.1774.

  PMID: 17846397 BACKGROUND

• Petrella RJ, Koval JJ, Cunningham DA, Paterson DH. Can primary care doctors prescribe exercise to improve fitness? The Step Test Exercise Prescription (STEP) project. Am J Prev Med. 2003 May;24(4):316-22. doi: 10.1016/s0749-3797(03)00022-9.

  PMID: 12726869 BACKGROUND

• Brown JB, Harris SB, Webster-Bogaert S, Wetmore S, Faulds C, Stewart M. The role of patient, physician and systemic factors in the management of type 2 diabetes mellitus. Fam Pract. 2002 Aug;19(4):344-9. doi: 10.1093/fampra/19.4.344.

  PMID: 12110552 BACKGROUND

• Kirk SF, Tytus R, Tsuyuki RT, Sharma AM. Weight management experiences of overweight and obese Canadian adults: findings from a national survey. Chronic Dis Inj Can. 2012 Mar;32(2):63-9.

  PMID: 22414302 BACKGROUND

• Dahrouge S, Dinh T. The economic impact of improvements in primary healthcare performance. [electronic resource]: Ottawa, Ont.] : Canadian Health Services Research Foundation, 2012 (Saint-Lazare, Quebec : Canadian Electronic Library, 2012); 2012.

  BACKGROUND

• Tsai AG, Wadden TA. Treatment of obesity in primary care practice in the United States: a systematic review. J Gen Intern Med. 2009 Sep;24(9):1073-9. doi: 10.1007/s11606-009-1042-5. Epub 2009 Jun 27.

  PMID: 19562419 BACKGROUND

• McAlister FA, Stewart S, Ferrua S, McMurray JJ. Multidisciplinary strategies for the management of heart failure patients at high risk for admission: a systematic review of randomized trials. J Am Coll Cardiol. 2004 Aug 18;44(4):810-9. doi: 10.1016/j.jacc.2004.05.055.

  PMID: 15312864 BACKGROUND

• Singh S, Devanna S, Edakkanambeth Varayil J, Murad MH, Iyer PG. Physical activity is associated with reduced risk of esophageal cancer, particularly esophageal adenocarcinoma: a systematic review and meta-analysis. BMC Gastroenterol. 2014 May 30;14:101. doi: 10.1186/1471-230X-14-101.

  PMID: 24886123 BACKGROUND

• Forman MR, Hursting SD, Umar A, Barrett JC. Nutrition and cancer prevention: a multidisciplinary perspective on human trials. Annu Rev Nutr. 2004;24:223-54. doi: 10.1146/annurev.nutr.24.012003.132315.

  PMID: 15189120 BACKGROUND

• Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren M, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvanne M, Scholte op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; European Association for Cardiovascular Prevention & Rehabilitation (EACPR); ESC Committee for Practice Guidelines (CPG). European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J. 2012 Jul;33(13):1635-701. doi: 10.1093/eurheartj/ehs092. Epub 2012 May 3. No abstract available.

  PMID: 22555213 BACKGROUND

• Handelsman Y, Mechanick JI, Blonde L, Grunberger G, Bloomgarden ZT, Bray GA, Dagogo-Jack S, Davidson JA, Einhorn D, Ganda O, Garber AJ, Hirsch IB, Horton ES, Ismail-Beigi F, Jellinger PS, Jones KL, Jovanovic L, Lebovitz H, Levy P, Moghissi ES, Orzeck EA, Vinik AI, Wyne KL; AACE Task Force for Developing a Diabetes Comprehensive Care Plan. American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for developing a diabetes mellitus comprehensive care plan: executive summary. Endocr Pract. 2011 Mar-Apr;17(2):287-302. doi: 10.4158/ep.17.2.287. No abstract available.

  PMID: 21474421 BACKGROUND

• Brenner DR. Cancer incidence due to excess body weight and leisure-time physical inactivity in Canada: implications for prevention. Prev Med. 2014 Sep;66:131-9. doi: 10.1016/j.ypmed.2014.06.018. Epub 2014 Jun 23.

  PMID: 24967956 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Doug Klein, MD, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 8, 2016
• Study Start: August 1, 2016
• Primary Completion: June 30, 2022
• Study Completion: January 10, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share