Study of Clinic-delivered Physical Activity Referrals to Cancer Survivors

NCT05216380 | Completed Results

• 2 other identifiers: H000215621K12HL138049-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Keywords

Cancer; Physical Activity; Cardiovascular Disease; Referrals

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Proportion of Eligible Clinic Staff Who Enroll

  12 weeks from launch of referrals (baseline)

• Proportion of Referred Patients Who Enroll in Programs

  At study completion, within 3 months of referral completion

Study Arms (1)

ActivityLink

EXPERIMENTAL

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

Behavioral: ActivityLink

Interventions

ActivityLink 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

ActivityLink

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Neoplasms; Sedentary Behavior; Motor Activity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Jamie Faro
• Organization: UMass Chan Medical School

Jamie.faro@umassmed.edu

7744553744

Study Officials

• Jamie M Faro, PhD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 31, 2022
• Study Start: March 15, 2021
• Primary Completion: March 30, 2022
• Study Completion: June 12, 2022
• Last Updated: August 23, 2024
• Results First Posted: August 15, 2023

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)