ClinicalTrials.gg
CompletedNCT02751580Updated May 16, 2025Results posted

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

An interventional study of Telemedicine and Questionnaire Administration in Malignant Neoplasm, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malignant Neoplasm

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03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 37 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University is the lead sponsor of 120 studies on the registry; none are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 7 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients currently undergoing or planned to start radiation treatment with curative, adjuvant or palliative intent
  • performance status (KPS) score >= 60
  • Patients must be capable to read and speak English and provide study specific 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

Exclusion Criteria:

  • \< 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • 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: Telemedicine · Other: Questionnaire Administration

Interventions

  • OtherTelemedicine

    Attend a virtual visit via the JeffConnect telehealth app

    Also known as: Telehealth

  • OtherQuestionnaire Administration

    Ancillary studies

06

What researchers measure

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.

    Time frame: 24 months from first patient enrolled

Secondary outcomes

  1. 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.

    Time frame: 4 months from enrollment

  2. 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

    Time frame: 4 months from enrollment

  3. 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.

    Time frame: 4 months from enrollment

  4. 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.

    Time frame: 4 months from enrollment

  5. 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.

    Time frame: 4 months from enrollment

  6. Patient Costs for Telehealth Visit

    Patient costs for telehealth visit based on questionnaire response

    Time frame: Through study completion

  7. Clinic Savings Derived From Telehealth Visits

    Clinic savings derived from telehealth visits v in-person visits

    Time frame: Through study completion

07

Results

Posted Dec 31, 2020

Participant flow

Participant flow — Overall Study
MilestoneHealth Services Research (Telehealth)
Started37
Completed31
Not completed6
Withdrew: Lost to follow-up4
Withdrew: Death2

Outcome measures

PrimaryFeasibility 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.

Time frame:
24 months from first patient enrolled
Reported as:
Mean · participants accrued per month
Feasibility of Conducting a Future Randomized Clinical Trial Comparing Telehealth and in Person Visits (i.e., Rate of Accrual)
participants accrued per monthHealth Services Research (Telehealth)
Feasibility of Conducting a Future Randomized Clinical Trial Comparing Telehealth and in Person Visits (i.e., Rate of Accrual)2.4 ± 1.67
SecondaryPatient 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.

Time frame:
4 months from enrollment
Reported as:
Count of participants · Participants
Patient Satisfaction With Telehealth Visits as Measured by the Patients Satisfaction With Cancer Care Score
ParticipantsHealth Services Research (Telehealth)
Strongly agreed32
Agreed5
SecondaryNumber 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

Time frame:
4 months from enrollment
Reported as:
Count of participants · Participants
Number of Patients Satisfied With Physician Communication During Telehealth Visit
ParticipantsHealth Services Research (Telehealth)
Number of Patients Satisfied With Physician Communication During Telehealth Visit37
SecondaryPatient 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.

Time frame:
4 months from enrollment
Reported as:
Count of participants · Participants
Patient Distrust in the Healthcare System as Measured by the Health Care System Distrust Scale in Relation to Privacy of Medical Record (MR)
ParticipantsHealth Services Research (Telehealth)
Agree MR could be access without permission5
Unsure MR are kept private5
SecondaryPhysicians 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.

Time frame:
4 months from enrollment
Reported as:
Count of participants · Participants
Physicians Ability to Evaluate a Patient During a Telehealth Visit as Measured by the Physician Questionnaire
ParticipantsHealth Services Research (Telehealth)
Assess Symptoms11
Assess Treatment-Related Toxicity9
SecondaryPhysician 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.

Time frame:
4 months from enrollment
Reported as:
Count of participants · Participants
Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale
ParticipantsHealth Services Research (Telehealth)
Accurately Assess Symptoms11
Accurately Assess Treatment-related toxicity9
Obtained All Information Needed for Patient Care8
Agreed Would Use Telehealth in future10
SecondaryPatient Costs for Telehealth Visit

Patient costs for telehealth visit based on questionnaire response

Time frame:
Through study completion

No measurements were reported for this outcome.

SecondaryClinic Savings Derived From Telehealth Visits

Clinic savings derived from telehealth visits v in-person visits

Time frame:
Through study completion

No measurements were reported for this outcome.

Adverse events

Collected over baseline through 16 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Health Services Research (Telehealth)2/37 (5.4%)0/37 (0%)0/37 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Health Services Research (Telehealth)
<=18 years0
Between 18 and 65 years23
>=65 years14
Sex: Female, Male
Sex: Female, Male(Participants)Health Services Research (Telehealth)
Female22
Male15
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Health Services Research (Telehealth)
Hispanic or Latino2
Not Hispanic or Latino35
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Health Services Research (Telehealth)
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American13
White23
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Health Services Research (Telehealth)
United States37
08

Study locations

1 site
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2016 to primary completion in Aug 2018, 28 months.

Results were first posted in Dec 2020, 2 years 4 months after primary completion.

Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 28 months is close to that.

Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2016
First posted
Apr 26, 2016
StartActual
Mar 23, 2016
Primary completionActual
Aug 8, 2018
CompletionActual
Aug 8, 2018
Results first posted
Dec 31, 2020
Last update
May 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02751580
Responsible party
Sponsor
First posted
Apr 26, 2016
Start date
Mar 23, 2016
Primary completion
Aug 8, 2018
Completion
Aug 8, 2018
Results posted
Dec 31, 2020
Last update
May 16, 2025

Study contacts

Nicole Simone, MD
principal investigator · Thomas Jefferson University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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