Trial Outcomes & Findings for Telehealth in Improving Quality of Life in Patients During Post Radiation Therapy Visits (NCT NCT02751580)

NCT ID: NCT02751580

Last Updated: 2025-05-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: 24 months from first patient enrolled
• Results posted on: 2025-05-16

Participant Flow

Participant milestones

Measure	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. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies
Overall Study STARTED	37
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	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. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies
Overall Study Lost to Follow-up	4
Overall Study Death	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Health Services Research (Telehealth) n=37 Participants Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months from first patient enrolled

Population: 13 participants did not complete the Telehealth visit: 7 did not show for their appointment, 4 were never scheduled, 1 patient passed away prior to completion of visit and 1 patient canceled the appointment in favor of hospice care

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.

Outcome measures

Measure	Health Services Research (Telehealth) n=37 Participants Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies
Feasibility of Conducting a Future Randomized Clinical Trial Comparing Telehealth and in Person Visits (i.e., Rate of Accrual)	2.4 participants accrued per month Standard Deviation 1.67

SECONDARY outcome

Timeframe: 4 months from enrollment

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.

Outcome measures

Measure	Health Services Research (Telehealth) n=37 Participants Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies
Patient Satisfaction With Telehealth Visits as Measured by the Patients Satisfaction With Cancer Care Score Agreed	5 Participants
Patient Satisfaction With Telehealth Visits as Measured by the Patients Satisfaction With Cancer Care Score Strongly agreed	32 Participants

SECONDARY outcome

Timeframe: 4 months from enrollment

Population: All 37 patients analyzed report satisfaction

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

Outcome measures

Measure	Health Services Research (Telehealth) n=37 Participants Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies
Number of Patients Satisfied With Physician Communication During Telehealth Visit	37 Participants

SECONDARY outcome

Timeframe: 4 months from enrollment

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.

Outcome measures

Measure	Health Services Research (Telehealth) n=37 Participants Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies
Patient Distrust in the Healthcare System as Measured by the Health Care System Distrust Scale in Relation to Privacy of Medical Record (MR) Agree MR could be access without permission	5 Participants
Patient Distrust in the Healthcare System as Measured by the Health Care System Distrust Scale in Relation to Privacy of Medical Record (MR) Unsure MR are kept private	5 Participants

SECONDARY outcome

Timeframe: 4 months from enrollment

Population: 9 physicians and 2 nurses evaluated the use of telehealth platform

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.

Outcome measures

Measure	Health Services Research (Telehealth) n=11 Participants Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies
Physicians Ability to Evaluate a Patient During a Telehealth Visit as Measured by the Physician Questionnaire Assess Symptoms	11 Participants
Physicians Ability to Evaluate a Patient During a Telehealth Visit as Measured by the Physician Questionnaire Assess Treatment-Related Toxicity	9 Participants

SECONDARY outcome

Timeframe: 4 months from enrollment

Population: 9 physicians and 2 nurse practitioners

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.

Outcome measures

Measure	Health Services Research (Telehealth) n=11 Participants Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. Telemedicine: Attend a virtual visit via the JeffConnect telehealth app Questionnaire Administration: Ancillary studies
Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale Obtained All Information Needed for Patient Care	8 Participants
Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale Accurately Assess Symptoms	11 Participants
Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale Accurately Assess Treatment-related toxicity	9 Participants
Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale Agreed Would Use Telehealth in future	10 Participants

SECONDARY outcome

Timeframe: Through study completion

Population: Sincere efforts have been made to obtain the results information from the Principal Investigator, but no reportable information has been obtained.

Patient costs for telehealth visit based on questionnaire response

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion

Population: Sincere efforts have been made to obtain the results information from the Principal Investigator, but no reportable information has been obtained.

Clinic savings derived from telehealth visits v in-person visits

Outcome measures

Outcome data not reported

Adverse Events

Health Services Research (Telehealth)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nicole Simone, MD

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215-955-6702

Email: nicole.simone@jefferson.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place