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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05216380
Enrollment
69
Registered
2022-01-31
Start date
2021-03-15
Completion date
2022-06-12
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Physical Inactivity

Keywords

Cancer, Physical Activity, Cardiovascular Disease, Referrals

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.

Interventions

BEHAVIORALActivityLink

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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The Number of Patients Referred Using the Secure Webform12 weeks from launch of referrals (baseline)The number of patients clinicians referred using the secure webform

Secondary

MeasureTime frameDescription
Proportion of Eligible Clinic Staff Who Enroll12 weeks from launch of referrals (baseline)Proportion of eligible clinic staff who enrolled in the study to deliver referrals
Proportion of Referred Patients Who Enroll in ProgramsAt study completion, within 3 months of referral completionProportion of referred patients who enroll in programs

Countries

United States

Participant flow

Participants by arm

ArmCount
ActivityLink
ActivityLink will be a clinic implementation program delivered to clinic staff. 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
54
Total54

Baseline characteristics

CharacteristicActivityLink
Age, Customized
Age
60.5 years
STANDARD_DEVIATION 11.8
Number of patients referred54 Participants
Race and Ethnicity Not Collected— Participants
Sex/Gender, Customized
Female
42 Participants
Sex/Gender, Customized
Male
12 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 54
other
Total, other adverse events
0 / 54
serious
Total, serious adverse events
0 / 54

Outcome results

Primary

The Number of Patients Referred Using the Secure Webform

The number of patients clinicians referred using the secure webform

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

Population: This represents the total number of patients accepting referrals from their provider. There were no data on those patients who did not accept referrals, thus we can only record the number accepted.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ActivityLinkThe Number of Patients Referred Using the Secure Webform54 Participants
Secondary

Proportion of Eligible Clinic Staff Who Enroll

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

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

Population: Clinician participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ActivityLinkProportion of Eligible Clinic Staff Who Enroll15 Participants
Secondary

Proportion of Referred Patients Who Enroll in Programs

Proportion of referred patients who enroll in programs

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

Population: Patients who enrolled in programs

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ActivityLinkProportion of Referred Patients Who Enroll in Programs19 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026