Malignant NeoplasmNCT02751580
Telehealth in Improving Quality of Life in Patients During Post Radiation Therapy Visits
A study testing Telemedicine and Questionnaire Administration in people with Malignant Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Telemedicine and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2016to 8 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To examine feasibility of conducting a trial comparing a telehealth visit and an in person office visit.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Malignant Neoplasm
- Being tested
- Telemedicine, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Also called Telehealth
Attend a virtual visit via the JeffConnect telehealth app
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telemedicine; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months from first patient enrolled
Secondary outcomes (7)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months from enrollment
Patient Costs for Telehealth Visit
Patient costs for telehealth visit based on questionnaire response
Measured: Through study completion
Clinic Savings Derived From Telehealth Visits
Clinic savings derived from telehealth visits v in-person visits
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start23 Mar 2016
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Simone, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751580
- Sponsor's protocol ID
- 15D.580
- Other IDs
- JT 8256
- Status last verified
- May 2025
- First submitted
- 11 Apr 2016
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TELEPORT STUDY: A Pilot Feasibility Trial Examining The Use of Telehealth in Post Radiation Therapy Visits
- ClinicalTrials.gov ID
- NCT02751580
- Acronym / sponsor ID
- 15D.580
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To examine feasibility of conducting a trial comparing a telehealth visit and an in person office visit.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (telehealth) | Experimental | Other: Telemedicine, Other: Questionnaire AdministrationPatients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application downloaded onto their electronic device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineAlso: TelehealthAttend a virtual visit via the JeffConnect telehealth app | Other | Health services research (telehealth) |
| Questionnaire AdministrationAncillary studies | Other | Health services research (telehealth) |
Primary outcome
Feasibility of Conducting a Future Randomized Clinical Trial Comparing Telehealth and in Person Visits (i.e., Rate of Accrual)
Time frame: 24 months from first patient enrolled
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.
7 secondary outcomes
Patient Satisfaction With Telehealth Visits as Measured by the Patients Satisfaction With Cancer Care Score
Time frame: 4 months from enrollment
Number of Patients Satisfied With Physician Communication During Telehealth Visit
Time frame: 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)
Time frame: 4 months from enrollment
Physicians Ability to Evaluate a Patient During a Telehealth Visit as Measured by the Physician Questionnaire
Time frame: 4 months from enrollment
Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale
Time frame: 4 months from enrollment
Patient Costs for Telehealth Visit
Time frame: Through study completion
Clinic Savings Derived From Telehealth Visits
Time frame: Through study completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Jefferson University HospitalsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Simone, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine and Questionnaire Administration in people with Malignant Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Conducting a Future Randomized Clinical Trial Comparing Telehealth and in Person Visits (i.e., Rate of Accrual) (time frame: 24 months from first patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.