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OpenTrials
Completed

NCT Number: NCT05216380

Study of Clinic-delivered Physical Activity Referrals to 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.

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Key information

Conditions

Cancer Behavior Cardiovascular Diseases Motor Activity Neoplasms Physical Inactivity Sedentary Behavior

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01605, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ActivityLink

Behavioral

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

Primary outcomes

  1. The Number of Patients Referred Using the Secure Webform

    Time frame: 12 weeks from launch of referrals (baseline)

    The number of patients clinicians referred using the secure webform

Secondary outcomes

  1. Proportion of Eligible Clinic Staff Who Enroll

    Time frame: 12 weeks from launch of referrals (baseline)

    Proportion of eligible clinic staff who enrolled in the study to deliver referrals

  2. Proportion of Referred Patients Who Enroll in Programs

    Time frame: At study completion, within 3 months of referral completion

    Proportion of referred patients who enroll in programs

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2022
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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