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

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ClinicalTrials.gov Identifier: NCT02751580
Recruitment Status : Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Other: Telemedicine Other: Questionnaire Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: TELEPORT STUDY: A Pilot Feasibility Trial Examining The Use of Telehealth in Post Radiation Therapy Visits
Actual Study Start Date : March 23, 2016
Actual Primary Completion Date : August 8, 2018
Estimated Study Completion Date : August 2021

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: Telemedicine
Attend a virtual visit via the JeffConnect telehealth app
Other Name: Telehealth

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Feasibility of conducting a future randomized clinical trial comparing telehealth and in person visits (i.e., rate of accrual) [ Time Frame: Through study completion, an average of 5 years ]
    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.


Secondary Outcome Measures :
  1. Patient satisfaction with telehealth visits as measured by the Patients Satisfaction with Cancer Care score [ Time Frame: Through study completion, an average of 5 years ]
    The average will be computed and tested against the null value of 75 using a one-sample t-test with alpha 0.05.

  2. Patient assessment of physician communication during telehealth visit as measured by the Communication assessment tool [ Time Frame: Through study completion, an average of 5 years ]
  3. Patient distrust in the healthcare system as measured by the health care system distrust scale [ Time Frame: Through study completion, an average of 5 years ]
  4. Physicians ability to evaluate a patient during a telehealth visit as measured by the physician questionnaire [ Time Frame: Through study completion, an average of 5 years ]
  5. Physician satisfaction with post-treatment telehealth visit as measured by the modified physician satisfaction scale [ Time Frame: Through study completion, an average of 5 years ]
  6. Patient costs for telehealth visit based on questionnaire response [ Time Frame: Through study completion, an average of 5 years ]
  7. Clinic savings derived from telehealth visits [ Time Frame: Through study completion, an average of 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751580


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Nicole Simone, MD Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02751580     History of Changes
Other Study ID Numbers: 15D.580
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Neoplasms