Telehealth in Improving Quality of Life in Patients During Post Radiation Therapy Visits

TELEPORT STUDY: A Pilot Feasibility Trial Examining The Use of Telehealth in Post Radiation Therapy Visits

This pilot clinical trial studies how well telehealth works in patients during post radiation therapy visits. A telehealth virtual office visit can be performed from the patient's home or workplace, decreasing time spent traveling to visit site, time spent in waiting room, and cost to patient. Studying telehealth may improve quality of life in patients during post radiation therapy visit.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Telemedicine

Detailed Description

PRIMARY OBJECTIVES:

I. To examine feasibility of conducting a trial comparing a telehealth visit and an in person office visit.

SECONDARY OBJECTIVES:

I. To examine patient satisfaction, patient assessment of physician communication during a telehealth visit.

II. To examine patient distrust in the healthcare system following a telehealth visit.

III. To examine physician ability to perform a patient assessment during a telehealth visit.

IV. To examine physician perceptions of telehealth visits. V. To examine monetary and time cost to patients for telehealth visit. VI. To calculate clinic savings derived from telehealth visits.

OUTLINE:

Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients currently undergoing or planned to start radiation treatment with curative, adjuvant or palliative intent
• Karnofsky performance status (KPS) score >= 60
• Patients must be capable to read and speak English and provide study specific informed consent prior to study entry
• Patients must have access to a computer or smartphone and internet connection at home on which they would be willing to do a telehealth study
• Pennsylvania or New Jersey residents *Telehealth visits for New Jersey residents will only be performed by physicians with a current medical license issued by the state of New Jersey.

Exclusion Criteria:

• KPS < 60%
• No access to a computer, smartphone or internet
• Unable to read and/or speak English
• Decisionally impaired patients
• Patients not residing in Pennsylvania or New Jersey

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health services research (telehealth); Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device.	Other: Questionnaire Administration; Ancillary studies; Other: Telemedicine; Attend a virtual visit via the JeffConnect telehealth app; Other Names: Telehealth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Conducting a Future Randomized Clinical Trial Comparing Telehealth and in Person Visits (i.e., Rate of Accrual)	The number of patients accrued each month will be analyzed via Poisson regression. The mean (monthly rate) will be estimated and tested against the null value of 4 patients per month using a 1-sided test with alpha 0.05. The proportion of enrolled subjects who are lost to follow-up will also be summarized.	24 months from first patient enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction With Telehealth Visits as Measured by the Patients Satisfaction With Cancer Care Score	Patients Satisfaction with Cancer Care score is an 18-item questionnaire with answers on a 5-point Likert scale. Lower scores are associated with higher satisfaction with caner care. The average will be computed and tested against the null value of 75 using a one-sample t-test with alpha 0.05.	4 months from enrollment
Number of Patients Satisfied With Physician Communication During Telehealth Visit	14 item communication assessment tool (CAT). The CAT addresses specifically patient satisfaction with key aspects of communication and interpersonal skills and items are scored on a 1-5 scale where 1 = poor and 5 = excellent and a higher score would indicate better communication skills	4 months from enrollment
Patient Distrust in the Healthcare System as Measured by the Health Care System Distrust Scale in Relation to Privacy of Medical Record (MR)	healthcare system distrust scale, designed to assess the belief that physicians would act in a patient's best interest to prevent a potentially negative important outcome (ref). This is a 10 item survey scored 1-5 where 1 = "strongly disagree" and 5 = "strongly agree" and higher scores generally indicate more distrust. Patient distrust was measured by asking if patients felt their Medical Record (MR) would be kept private or would be accessed without their permission.	4 months from enrollment
Physicians Ability to Evaluate a Patient During a Telehealth Visit as Measured by the Physician Questionnaire	9 question survey regarding the ease of use and efficacy of the telehealth platform. The items were yes or no questions (scored on 1 = yes and 0 = no) scale. Higher scores represent greater satisfaction with the platform.	4 months from enrollment
Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale	9-question survey regarding the ease of use and efficacy of the telehealth platform. The items were yes or no questions (scored on 1=yes and 0=no) scale. Higher scores represented greater satisfaction with the platform. Specifically looked at responses to the items regarding: accurate assessment of symptoms via telehealth, accurately assess treatment-related toxicity via telehealth, feeling sure they obtained all information needed to care for the patient, and if providers would use the telehealth system in the future.	4 months from enrollment
Patient Costs for Telehealth Visit	Patient costs for telehealth visit based on questionnaire response	Through study completion
Clinic Savings Derived From Telehealth Visits	Clinic savings derived from telehealth visits v in-person visits	Through study completion

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Nicole Simone, MD, Thomas Jefferson University

Publications and helpful links

Helpful Links

• Jefferson University Hospitals
• Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2016
• Primary Completion (Actual): August 8, 2018
• Study Completion (Actual): August 8, 2018

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimated): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 15D.580