Study of Clinic-delivered Physical Activity Referrals to Cancer Survivors

ActivityLink: Clinic-to-Community Physical Activity Referrals for Cardiovascular Disease Risk Reduction in Cancer Survivors.

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Physical Inactivity
• Intervention / Treatment: Behavioral: ActivityLink

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts Chan Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Aim 1a:

• Medical providers who are 1) Are a current UMass Cancer Clinic patient navigator, oncologist, radiologist, or cardiologist 2) Consent to participate in the study.
• Program leaders who are 1) In charge of implementing evidence-based physical activity program for cancer patients/survivors (LIVESTRONG at the Y); 2) Consent to participate in the study.
• Patients who receive treatments at the UMass Cancer Clinics who are 1) Are at least 18 years of age; and 2) Consent to participate in the study.

Exclusion Criteria for Aim 1a:

• Medical providers who are 1) Not currently employed at UMass Memorial Health (UMH), 2) Not involved in direct treatment of care coordination of cancer patients
• Program leaders who are 1) not involved in the implementation of an evidence-based physical activity program for cancer survivors
• Patients who are 1) Unable or unwilling to provide informed consent; 2) <18 years of age.

Inclusion Criteria for Aim 1b:

• Participants for Aim 1b are eligible if they are: 1) Are a UMass Cancer Clinic patient navigator; and 2) Consent to participate in the study.

Inclusion criteria for Aim 2:

• Clinic staff who 1) Are a current UMass Cancer Clinic staff delivering care to patients 2) Consent to participate in the study.
• Program leaders who are 1) In charge of implementing evidence-based physical activity program that clinic staff refer cancer patients/survivors to (LIVESTRONG at the Y and FitCancer); 2) Consent to participate in the study.
• Patients who receive a physical activity program referral during their survivorship care planning from UMass Cancer Clinics who are 1) Are at least 18 years of age; and 2) Consent to participate in the study.

Exclusion Criteria for Aim 2:

• Clinic staff who are 1) Not currently employed at UMass, 2) Not implementing patient treatment of care coordination of cancer patients
• Program leaders who are 1) not involved in the implementation of an evidence-based physical activity program clinic staff refer cancer survivors to
• Patients who are 1) Unable or unwilling to provide informed consent; and 2) <18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ActivityLink; ActivityLink will be a clinic implementation program delivered to clinic staff.

Behavioral: ActivityLink; ActivityLink is an implementation program using: Didactic and experiential training sessions for clinic staff to conduct referrals; Secure electronic referral webform to refer patients using their email address and phone number; Messaging sent to the patient and provider that they have been referred to a program; Clinic visual cues (flyers and paper prescription pad) to reinforce referrals; Motivational messaging and booster sessions from study staff to encourage referrals and troubleshoot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Patients Referred Using the Secure Webform	The number of patients referred using the secure webform	12 weeks from launch of referrals (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Qualitative feedback from enrolled clinic staff and referred survivors, using PRISM framework to assess barriers to implementation and program referrals	At study completion, within 3 months of referral completion
Proportion of Eligible Clinic Staff Who Enroll	Proportion of eligible clinic staff who enroll	12 weeks from launch of referrals (baseline)
Proportion of Referred Patients Who Enroll in Programs	Proportion of referred patients who enroll in programs	At study completion, within 3 months of referral completion

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Jamie M Faro, PhD, UMass Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): June 12, 2022

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Cancer; Cardiovascular Disease; Referrals
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: H00021562; 1K12HL138049-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No