Cancer and Chronic Disease PreventionNCT03052959
BETTER HEALTH: Durham
A study testing Immediate Intervention and Wait List Intervention in people with Cancer and Chronic Disease Prevention, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The BETTER intervention consists of supportive meetings between a specially trained prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic disease prevention and screening activities (CDPS). Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer and Chronic Disease Prevention
- What is being tested?
- Immediate Intervention and Wait List Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2017to 28 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged 40 - 64 years living in sampled low income clusters in Durham region who are English speakers (including illiterate persons). Only one participant per residential household may participate.
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building on Existing Tools To Improve Chronic Disease Prevention and Screening in Public Health: Durham
The BETTER intervention consists of supportive meetings between a specially trained prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic disease prevention and screening activities (CDPS). The prevention practitioner nurse will assist participants to identify goals for accomplishing CDPS activities in the next 6 months. Promotion, recruitment of participants and delivery of the BETTER intervention will be adapted to meet the needs of the residents through the use of participatory research methods and community engagement strategies. The study population consists of individuals aged 40-64 years living in 10 designated areas or "clusters" within Durham Region in Oshawa and Whitby.
Objectives:
Read more
- Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities.
- Evaluate whether the prevention practitioner was effective in helping people achieve their goals and explore whether this type of intervention could work in other settings.
- Share what the investigators learn with government and other public health units in Ontario and across Canada.
Some clusters will receive the BETTER intervention right away and other clusters will be in a wait-list control group to receive the intervention 6 months later. Our main outcome is the change in a score that considers the number of preventive health items a person has achieved during the 6 months. The investigators will also be doing in-depth interviews and focus groups with health care providers, community organizations and people who live in the designated areas to understand whether the primary practitioner was effective.
Read the detailed description
Research has shown that many Ontarians do not participate in all the chronic disease prevention and screening activities that could keep them healthy. Previous studies have found that a prevention practitioner, a nurse who works with health care providers and their practices, can be effective at improving the uptake of chronic disease prevention and screening activities.
The goal of this study is to adapt the BETTER intervention from a health care setting with family practice teams to a community-based strategy in designated areas in Durham Region. The BETTER intervention consists of supportive meetings between a specially trained prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic disease prevention and screening activities (CDPS). The prevention practitioner nurse will assist participants to identify goals for accomplishing CDPS activities in the next 6 months. Promotion, recruitment of participants and delivery of the BETTER intervention will be adapted to meet the needs of the residents through the use of participatory research methods and community engagement strategies.
Previous work by the researchers identified census dissemination areas in Ontario with: (1) the lowest quintile of median household income, (2) low cancer screening rates, and 3) poor access to primary care services. The study population consists of individuals aged 40-64 years living in 10 designated areas or "clusters" within Durham Region in Oshawa and Whitby. The investigators will be working closely with local community agencies and primary care providers to identify people who may benefit from this study.
Objectives:
- Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities.
- Evaluate whether the prevention practitioner was effective in helping people achieve their goals and explore whether this type of intervention could work in other settings.
- Share what the investigators learn with government and other public health units in Ontario and across Canada.
Some clusters will receive the BETTER intervention right away and other clusters will be in a wait-list control group to receive the intervention 6 months later. The investigators will compare the two groups. The study will involve about 120 residents in 10 designated areas. Our main outcome is the change in a score that considers the number of preventive health items a person has achieved during the 6 months. The investigators will also be doing in-depth interviews and focus groups with health care providers, community organizations and people who live in the designated areas to understand whether the primary practitioner was effective.
- Conditions
- Cancer and Chronic Disease Prevention
- Being tested
- Immediate Intervention, Wait List Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate InterventionBehavioural
The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
Wait List InterventionOther
The control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Not described Receives: Behavioral: Immediate Intervention |
| Wait List Intervention | Other | Not described Receives: Other: Wait List Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up
The primary outcome measure is the mean percentage of the number of eligible CDPS actions at baseline that are subsequently met (by self-report) at follow-up, measured at the patient level. As a function of baseline characteristics, certain individuals are eligible for certain CDPS actions. At follow-up, each patient will be re-evaluated and the number of eligible actions met will be enumerated. Six months after the baseline survey interview, the research assistant will administer the outcome survey on health and CDPS actions to participants in intervention and control clusters alike. All outcomes are self-reports of the completion of CDPS actions.
Measured: Six months
Secondary outcomes (2)
Completion of Individual Actions
The investigators will report the frequency with which individual CDPS actions were completed, for those actions for which the individual was eligible at baseline
Measured: Six months
Number of Self-referrals
The investigators will report the frequency with which self-referrals were reported to the prevention practitioner.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start2 Oct 2017
- Primary completion28 Jan 2020
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer and Chronic Disease PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Durham Region Health Department, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Lawrence Paszat, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052959
- Sponsor's protocol ID
- 16-231
- Status last verified
- Oct 2021
- First submitted
- 10 Feb 2017
- Last updated
- 1 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Brien MA, Lofters A, Wall B, Elliott R, Makuwaza T, Pietrusiak MA, Grunfeld E, Riordan B, Snider C, Pinto AD, Manca D, Sopcak N, Cornacchi SD, Huizinga J, Sivayoganathan K, Donnelly PD, Selby P, Kyle R, Rabeneck L, Baxter NN, Tinmouth J, Paszat L. Adaptation and qualitative evaluation of the BETTER intervention for chronic disease prevention and screening by public health nurses in low income neighbourhoods: views of community residents. BMC Health Serv Res. 2024 Apr 4;24(1):427. doi: 10.1186/s12913-024-10853-z.
PubMed 38575938Lofters AK, O'Brien MA, Sutradhar R, Pinto AD, Baxter NN, Donnelly P, Elliott R, Glazier RH, Huizinga J, Kyle R, Manca D, Pietrusiak MA, Rabeneck L, Riordan B, Selby P, Sivayoganathan K, Snider C, Sopcak N, Thorpe K, Tinmouth J, Wall B, Zuo F, Grunfeld E, Paszat L. Building on existing tools to improve chronic disease prevention and screening in public health: a cluster randomized trial. BMC Public Health. 2021 Aug 3;21(1):1496. doi: 10.1186/s12889-021-11452-x.
PubMed 34344340Paszat L, Sutradhar R, O'Brien MA, Lofters A, Pinto A, Selby P, Baxter N, Donnelly PD, Elliott R, Glazier RH, Kyle R, Manca D, Pietrusiak MA, Rabeneck L, Sopcak N, Tinmouth J, Wall B, Grunfeld E. BETTER HEALTH: Durham -- protocol for a cluster randomized trial of BETTER in community and public health settings. BMC Public Health. 2017 Sep 29;17(1):754. doi: 10.1186/s12889-017-4797-3.
PubMed 28962558
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building on Existing Tools To Improve Chronic Disease Prevention and Screening in Public Health: Durham
- ClinicalTrials.gov ID
- NCT03052959
- Acronym / sponsor ID
- 16-231
- Conditions
- Cancer and Chronic Disease Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Durham Region Health Department, University of Toronto
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Posted 1 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The BETTER intervention consists of supportive meetings between a specially trained prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic disease prevention and screening activities (CDPS). The prevention practitioner nurse will assist participants to identify goals for accomplishing CDPS activities in the next 6 months. Promotion, recruitment of participants and delivery of the BETTER intervention will be adapted to meet the needs of the residents through the use of participatory research methods and community engagement strategies. The study population consists of individuals aged 40-64 years living in 10 designated areas or "clusters" within Durham Region in Oshawa and Whitby.
Objectives:
- Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities.
- Evaluate whether the prevention practitioner was effective in helping people achieve their goals and explore whether this type of intervention could work in other settings.
- Share what the investigators learn with government and other public health units in Ontario and across Canada.
Some clusters will receive the BETTER intervention right away and other clusters will be in a wait-list control group to receive the intervention 6 months later. Our main outcome is the change in a score that considers the number of preventive health items a person has achieved during the 6 months. The investigators will also be doing in-depth interviews and focus groups with health care providers, community organizations and people who live in the designated areas to understand whether the primary practitioner was effective.
Detailed description
Research has shown that many Ontarians do not participate in all the chronic disease prevention and screening activities that could keep them healthy. Previous studies have found that a prevention practitioner, a nurse who works with health care providers and their practices, can be effective at improving the uptake of chronic disease prevention and screening activities.
The goal of this study is to adapt the BETTER intervention from a health care setting with family practice teams to a community-based strategy in designated areas in Durham Region. The BETTER intervention consists of supportive meetings between a specially trained prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic disease prevention and screening activities (CDPS). The prevention practitioner nurse will assist participants to identify goals for accomplishing CDPS activities in the next 6 months. Promotion, recruitment of participants and delivery of the BETTER intervention will be adapted to meet the needs of the residents through the use of participatory research methods and community engagement strategies.
Previous work by the researchers identified census dissemination areas in Ontario with: (1) the lowest quintile of median household income, (2) low cancer screening rates, and 3) poor access to primary care services. The study population consists of individuals aged 40-64 years living in 10 designated areas or "clusters" within Durham Region in Oshawa and Whitby. The investigators will be working closely with local community agencies and primary care providers to identify people who may benefit from this study.
Objectives:
- Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities.
- Evaluate whether the prevention practitioner was effective in helping people achieve their goals and explore whether this type of intervention could work in other settings.
- Share what the investigators learn with government and other public health units in Ontario and across Canada.
Some clusters will receive the BETTER intervention right away and other clusters will be in a wait-list control group to receive the intervention 6 months later. The investigators will compare the two groups. The study will involve about 120 residents in 10 designated areas. Our main outcome is the change in a score that considers the number of preventive health items a person has achieved during the 6 months. The investigators will also be doing in-depth interviews and focus groups with health care providers, community organizations and people who live in the designated areas to understand whether the primary practitioner was effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Immediate Intervention |
| Wait List Intervention | Other | Other: Wait List Intervention |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males and females aged 40 - 64 years living in sampled low income clusters in Durham region who are English speakers (including illiterate persons). Only one participant per residential household may participate.
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate InterventionThe 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department. | Behavioural | Immediate Intervention |
| Wait List InterventionThe control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study. | Other | Wait List Intervention |
Primary outcome
Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up
Time frame: Six months
The primary outcome measure is the mean percentage of the number of eligible CDPS actions at baseline that are subsequently met (by self-report) at follow-up, measured at the patient level. As a function of baseline characteristics, certain individuals are eligible for certain CDPS actions. At follow-up, each patient will be re-evaluated and the number of eligible actions met will be enumerated. Six months after the baseline survey interview, the research assistant will administer the outcome survey on health and CDPS actions to participants in intervention and control clusters alike. All outcomes are self-reports of the completion of CDPS actions.
2 secondary outcomes
Completion of Individual Actions
Time frame: Six months
Number of Self-referrals
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38575938O'Brien MA, Lofters A, Wall B, Elliott R, Makuwaza T, Pietrusiak MA, Grunfeld E, Riordan B, Snider C, Pinto AD, Manca D, Sopcak N, Cornacchi SD, Huizinga J, Sivayoganathan K, Donnelly PD, Selby P, Kyle R, Rabeneck L, Baxter NN, Tinmouth J, Paszat L. Adaptation and qualitative evaluation of the BETTER intervention for chronic disease prevention and screening by public health nurses in low income neighbourhoods: views of community residents. BMC Health Serv Res. 2024 Apr 4;24(1):427. doi: 10.1186/s12913-024-10853-z.
- Derived from this study: PubMed 34344340Lofters AK, O'Brien MA, Sutradhar R, Pinto AD, Baxter NN, Donnelly P, Elliott R, Glazier RH, Huizinga J, Kyle R, Manca D, Pietrusiak MA, Rabeneck L, Riordan B, Selby P, Sivayoganathan K, Snider C, Sopcak N, Thorpe K, Tinmouth J, Wall B, Zuo F, Grunfeld E, Paszat L. Building on existing tools to improve chronic disease prevention and screening in public health: a cluster randomized trial. BMC Public Health. 2021 Aug 3;21(1):1496. doi: 10.1186/s12889-021-11452-x.
- Derived from this study: PubMed 28962558Paszat L, Sutradhar R, O'Brien MA, Lofters A, Pinto A, Selby P, Baxter N, Donnelly PD, Elliott R, Glazier RH, Kyle R, Manca D, Pietrusiak MA, Rabeneck L, Sopcak N, Tinmouth J, Wall B, Grunfeld E. BETTER HEALTH: Durham -- protocol for a cluster randomized trial of BETTER in community and public health settings. BMC Public Health. 2017 Sep 29;17(1):754. doi: 10.1186/s12889-017-4797-3.
- Individual participant dataSharing planned: No
Related trials for Cancer and Chronic Disease Prevention
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Active, not recruitingPhase 2
Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Active, not recruitingPhase 1
Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients
Leukemia, Acute, Myelodysplastic Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Paszat principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Intervention and Wait List Intervention in people with Cancer and Chronic Disease Prevention, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03052959, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.