NCT02751580

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2018

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

December 31, 2020

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

April 11, 2016

Results QC Date

October 7, 2019

Last Update Submit

May 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Patient Satisfaction With Telehealth Visits as Measured by the Patients Satisfaction With Cancer Care Score

    4 months from enrollment

  • Number of Patients Satisfied With Physician Communication During Telehealth Visit

    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)

    4 months from enrollment

  • Physicians Ability to Evaluate a Patient During a Telehealth Visit as Measured by the Physician Questionnaire

    4 months from enrollment

  • Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale

    4 months from enrollment

  • +2 more secondary outcomes

Study Arms (1)

Health services research (telehealth)

EXPERIMENTAL

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

Other: TelemedicineOther: Questionnaire Administration

Interventions

Attend a virtual visit via the JeffConnect telehealth app

Also known as: Telehealth
Health services research (telehealth)

Ancillary studies

Health services research (telehealth)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Nicole Simone, MD
Organization
Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Officials

  • Nicole Simone, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 26, 2016

Study Start

March 23, 2016

Primary Completion

August 8, 2018

Study Completion

August 8, 2018

Last Updated

May 16, 2025

Results First Posted

December 31, 2020

Record last verified: 2025-05

Locations