Study of Clinic-delivered Physical Activity Referrals to Cancer Survivors

NCT ID: NCT05216380

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2022-06-12

Brief 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.

Conditions

Cancer; Physical Inactivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

ActivityLink

ActivityLink will be a clinic implementation program delivered to clinic staff.

Group Type: EXPERIMENTAL

ActivityLink

Intervention Type: BEHAVIORAL

ActivityLink is an implementation program using:

1. Didactic and experiential training sessions for clinic staff to conduct referrals

2. Secure electronic referral webform to refer patients using their email address and phone number

3. Messaging sent to the patient and provider that they have been referred to a program

4. Clinic visual cues (flyers and paper prescription pad) to reinforce referrals

5. Motivational messaging and booster sessions from study staff to encourage referrals and troubleshoot

Interventions

ActivityLink

ActivityLink is an implementation program using:

1. Didactic and experiential training sessions for clinic staff to conduct referrals

2. Secure electronic referral webform to refer patients using their email address and phone number

3. Messaging sent to the patient and provider that they have been referred to a program

4. Clinic visual cues (flyers and paper prescription pad) to reinforce referrals

5. Motivational messaging and booster sessions from study staff to encourage referrals and troubleshoot

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• 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

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Jamie Faro

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamie M Faro, PhD

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Locations

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K12HL138049-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H00021562

Identifier Type: -

Identifier Source: org_study_id