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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05863702
Other study ID # UPCC#: 11923
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 11, 2023
Est. completion date May 31, 2024

Study information

Verified date September 2023
Source Abramson Cancer Center at Penn Medicine
Contact Linda A Jacobs, PhD, CRNP
Phone 215-615-3371
Email linda.jacobs@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this project is to identify effective strategies to assist survivors of childhood and young adult cancers (diagnosed between birth and age 39) who have not returned for follow-up cancer care for 3 or more years, to reengage with the health care system. The investigator will evaluate the effect of a novel, bidirectional conversational agent ("Penny"), compared to usual care, to assist patients with scheduling appointments, lab work as well as scans and specialty appointments as needed.


Description:

To achieve this, the investigator will use a two-arm randomized controlled trial to explore how multilevel factors impact the acceptability and effectiveness of this strategy by collecting qualitative and quantitative data from patients. Penny is a conversational agent ("chatbot") that engages patients in real time via text messaging, allowing for bidirectional communication and motivational cues to promote adherence. The chatbot will assist patients who have not been see for cancer follow-up care, with scheduling follow-up appointments, labs, scans, specialty appointments, and monitor compliance with the appointments made.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 31, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patient (age > 18 years), male or female, diagnosed with cancer as a child or as a young adult, between birth and 39 years of age - Patient possession of a mobile device that can receive SMS texts - Ability to respond to questions and engage with "Penny" in English - Ability to provide informed consent to participate in the study - Approval of the patient's oncology care team for the patient to be involved in the study Exclusion Criteria: - Anyone who does not meet the inclusion criteria - Patients with a history of thyroid cancer or skin cancers

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Penny
The chatbot will assist patients who have not been see for cancer follow-up care, with scheduling follow-up appointments, labs, scans, specialty appointments, and monitor compliance with the appointments made.

Locations

Country Name City State
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the utilization of a chatbot (Penny) to increase receipt of evidence-based survivorship care in YA survivors of pediatric and YA cancers We will identify adult survivors of pediatric and YA cancers who have not been seen for follow-up care >3 years and evaluate patients' engagement with Penny to schedule return appointments and adhere to recommended life-long ongoing follow-up care according to the NCCN guidelines. Patients will be monitored over a 16-week period to see if they scheduled a follow-up care appointment. 1 year
Primary Number of patients who agree to use Penny and patient engagement overtime in those patients randomized to the Penny arm Percentage of initial responses to the conversation initiated by Penny (opt in vs. opt out) providing permission for text messaging 1 year
Primary Number of patients who agree to use Penny and patient engagement overtime in those patients randomized to the Penny arm Total number of times patients engage with Penny to schedule follow up appointments, scans, labs, recommendations for other services made at each clinical visit 1 year
Primary Number of patients who agree to use Penny and patient engagement overtime in those patients randomized to the Penny arm Total number of patients who engage with Penny throughout the study, schedule and are compliant with appointments, scans, labs, and referrals to other services made at each clinical visit 1 year
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