Study of Clinic-delivered Physical Activity Referrals to Cancer Survivors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05216380
• Other study ID #: H00021562
• Secondary ID: 1K12HL138049-01
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: June 12, 2022

Study information

• Verified date: August 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 12, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases
• Physical Inactivity

Intervention

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

Locations

Country	Name	City	State
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Eligible Clinic Staff Who Enroll	Proportion of eligible clinic staff who enroll	12 weeks from launch of referrals (baseline)
Secondary	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
Secondary	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