CancerNCT05216380
Study of Clinic-delivered Physical Activity Referrals to Cancer Survivors
A study testing ActivityLink in people with Cancer and Physical Inactivity, run by University of Massachusetts, Worcester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Physical Inactivity
- What is being tested?
- ActivityLink
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 12 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605
About this study
Official title: ActivityLink: Clinic-to-Community Physical Activity Referrals for Cardiovascular Disease Risk Reduction in 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.
- Conditions
- Cancer, Physical Inactivity
- Being tested
- ActivityLink
- Keywords
- Cancer, Physical Activity, Cardiovascular Disease, Referrals
- Medical subject headings
- Neoplasms, Sedentary Behavior, Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivityLinkBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| ActivityLink | Experimental | ActivityLink will be a clinic implementation program delivered to clinic staff. Receives: Behavioral: ActivityLink |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patients Referred Using the Secure Webform
The number of patients clinicians referred using the secure webform
Measured: 12 weeks from launch of referrals (baseline)
Secondary outcomes (2)
Proportion of Eligible Clinic Staff Who Enroll
Proportion of eligible clinic staff who enrolled in the study to deliver referrals
Measured: 12 weeks from launch of referrals (baseline)
Proportion of Referred Patients Who Enroll in Programs
Proportion of referred patients who enroll in programs
Measured: At study completion, within 3 months of referral completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start15 Mar 2021
- Primary completion30 Mar 2022
- Study completion12 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jamie Faro, University of Massachusetts, Worcester
- Investigators
- Jamie M Faro, PhD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216380
- Sponsor's protocol ID
- H00021562
- Other IDs
- 1K12HL138049-01
- Status last verified
- Aug 2024
- First submitted
- 5 Jan 2022
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ActivityLink: Clinic-to-Community Physical Activity Referrals for Cardiovascular Disease Risk Reduction in Cancer Survivors.
- ClinicalTrials.gov ID
- NCT05216380
- Acronym / sponsor ID
- H00021562
- Conditions
- Cancer, Physical Inactivity
- Keywords
- Cancer, Physical Activity, Cardiovascular Disease, Referrals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 12 Jun 2022 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Posted 15 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ActivityLink | Experimental | Behavioral: ActivityLinkActivityLink will be a clinic implementation program delivered to clinic staff. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActivityLinkActivityLink 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 | Behavioural | ActivityLink |
Primary outcome
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
2 secondary outcomes
Proportion of Eligible Clinic Staff Who Enroll
Time frame: 12 weeks from launch of referrals (baseline)
Proportion of Referred Patients Who Enroll in Programs
Time frame: At study completion, within 3 months of referral completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie M Faro, PhD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActivityLink in people with Cancer and Physical Inactivity, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Patients Referred Using the Secure Webform (time frame: 12 weeks from launch of referrals (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.