Malignant Neoplasm
Conditions
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.
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.
Interventions
OTHERTelemedicine
Attend a virtual visit via the JeffConnect telehealth app
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Conducting a Future Randomized Clinical Trial Comparing Telehealth and in Person Visits (i.e., Rate of Accrual) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Satisfied With Physician Communication During Telehealth Visit | 4 months from enrollment | 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 |
| 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 | 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. |
| Physicians Ability to Evaluate a Patient During a Telehealth Visit as Measured by the Physician Questionnaire | 4 months from enrollment | 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. |
| Patient Satisfaction With Telehealth Visits as Measured by the Patients Satisfaction With Cancer Care Score | 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. |
| Patient Costs for Telehealth Visit | Through study completion | Patient costs for telehealth visit based on questionnaire response |
| Clinic Savings Derived From Telehealth Visits | Through study completion | Clinic savings derived from telehealth visits v in-person visits |
| Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale | 4 months from enrollment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Health Services Research (Telehealth) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 37 |
| other Total, other adverse events | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Services Research (Telehealth) | 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
Clinic Savings Derived From Telehealth Visits
Clinic savings derived from telehealth visits v in-person visits
Time frame: 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.
Secondary
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
Population: All 37 patients analyzed report satisfaction
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Services Research (Telehealth) | Number of Patients Satisfied With Physician Communication During Telehealth Visit | 37 Participants |
Secondary
Patient Costs for Telehealth Visit
Patient costs for telehealth visit based on questionnaire response
Time frame: 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.
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services Research (Telehealth) | 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 |
| Health Services Research (Telehealth) | 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
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services Research (Telehealth) | Patient Satisfaction With Telehealth Visits as Measured by the Patients Satisfaction With Cancer Care Score | Strongly agreed | 32 Participants |
| Health Services Research (Telehealth) | Patient Satisfaction With Telehealth Visits as Measured by the Patients Satisfaction With Cancer Care Score | Agreed | 5 Participants |
Secondary
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
Population: 9 physicians and 2 nurses evaluated the use of telehealth platform
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services Research (Telehealth) | Physicians Ability to Evaluate a Patient During a Telehealth Visit as Measured by the Physician Questionnaire | Assess Symptoms | 11 Participants |
| Health Services Research (Telehealth) | Physicians Ability to Evaluate a Patient During a Telehealth Visit as Measured by the Physician Questionnaire | Assess Treatment-Related Toxicity | 9 Participants |
Secondary
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
Population: 9 physicians and 2 nurse practitioners
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services Research (Telehealth) | Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale | Accurately Assess Symptoms | 11 Participants |
| Health Services Research (Telehealth) | Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale | Accurately Assess Treatment-related toxicity | 9 Participants |
| Health Services Research (Telehealth) | Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale | Obtained All Information Needed for Patient Care | 8 Participants |
| Health Services Research (Telehealth) | Physician Satisfaction With Post-treatment Telehealth Visit as Measured by the Modified Physician Satisfaction Scale | Agreed Would Use Telehealth in future | 10 Participants |