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| ID | Type | Description | Link |
|---|---|---|---|
| 1K12HL138049-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Background: Cancer survivors have a greater risk of cardiovascular disease (CVD) and have low physical activity levels. Physical inactivity is one modifiable risk factor for CVD, and increased physical activity has shown a cardioprotective effect on lowering CVD risk. The objective of ActivityLink is to use an electronic referral (e-referral) implementation program for clinic staff to refer survivors to an in-person and a virtual physical activity program.
Methods: Participants in this study will include clinic staff and patients. Investigators will first conduct interviews with clinic staff and patients, followed by usability testing of a referral system with staff. The study team will then beta-test two rounds of testing using Plan, Do, Study, Act (PDSA) Cycles for clinic staff to refer patients in the clinic. Quantitative data and qualitative interviews will be collected following each PDSA cycle, with refinements made based on feedback.
Outcomes: The proposed study addresses a critical need to implement physical activity referrals into routine cancer survivorship visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ActivityLink | Experimental | ActivityLink will be a clinic implementation program delivered to clinic staff. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActivityLink | Behavioral | ActivityLink is an implementation program using:
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| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients Referred Using the Secure Webform | The number of patients clinicians referred using the secure webform | 12 weeks from launch of referrals (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eligible Clinic Staff Who Enroll | Proportion of eligible clinic staff who enrolled in the study to deliver referrals | 12 weeks from launch of referrals (baseline) |
| Proportion of Referred Patients Who Enroll in Programs |
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Inclusion Criteria for Aim 1a:
Exclusion Criteria for Aim 1a:
Inclusion Criteria for Aim 1b:
Inclusion criteria for Aim 2:
Exclusion Criteria for Aim 2:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie M Faro, PhD | UMass Chan Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01605 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ActivityLink | ActivityLink will be a clinic implementation program delivered to clinic staff. ActivityLink: ActivityLink is an implementation program using:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ActivityLink | ActivityLink will be a clinic implementation program delivered to clinic staff. ActivityLink: ActivityLink is an implementation program using:
|
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Patients Referred Using the Secure Webform | The number of patients clinicians referred using the secure webform | This represents the total number of patients accepting referrals from their provider. There were no data on those patients who did not accept referrals, thus we can only record the number accepted. | Posted | Count of Participants | Participants | 12 weeks from launch of referrals (baseline) |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ActivityLink | ActivityLink will be a clinic implementation program delivered to clinic staff. ActivityLink: ActivityLink is an implementation program using:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Faro | UMass Chan Medical School | 7744553744 | Jamie.faro@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2022 | Jul 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
Proportion of referred patients who enroll in programs
| At study completion, within 3 months of referral completion |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Number of patients referred | Count of Participants | Participants |
|
|
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| Secondary | Proportion of Eligible Clinic Staff Who Enroll | Proportion of eligible clinic staff who enrolled in the study to deliver referrals | Clinician participants | Posted | Count of Participants | Participants | 12 weeks from launch of referrals (baseline) |
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| Secondary | Proportion of Referred Patients Who Enroll in Programs | Proportion of referred patients who enroll in programs | Patients who enrolled in programs | Posted | Count of Participants | Participants | At study completion, within 3 months of referral completion |
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| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
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