Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 6:10 AM
Study NCT ID:
NCT07069868
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2025-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth in an Ambulatory Oncology Phase I Clinical Trial Unit
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Telehealth as a Nursing Strategy for Monitoring Patients in an Ambulatory Oncology Phase I Clinical Trial Unit
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aimed to evaluate the feasibility, acceptability, satisfaction and effectiveness of telehealth on early identification and mitigation of adverse events during cycle one of a Phase 1 oncology clinical trial.
Detailed Description:
Oncology patients in Phase 1 clinical trials receive study medications administered for the first time in humans. Participants need to be monitored closely for adverse events which can be serious and have critical implications.
A single group repeated measures design was used to evaluate the effect of telehealth on patient outcomes and patient experience for up to four telehealth sessions and nursing staff perceptions of telehealth. Enrollment was limited to 21 participants, in order to limit the number of patients for a pilot study.
Telehealth sessions began within seven days after the initial treatment and occurred weekly during cycle one of the participant's Phase 1 protocol. Side effects assessed by nursing included mucositis, nausea, vomiting, constipation, diarrhea, dyspnea, cough, rash, pain and fever. Patients were also given the opportunity to address other symptoms.
Original research was required to establish validity of telehealth for managing adverse events, dose limiting toxicities of study medications, and enhancing safe clinical care with potentially meeting unmet patient needs when beginning an oncology Phase 1 clinical trial.
Data Collection tools included:
1. Data collection Table which includes variables, sources of data and timeframes
2. Charlson Comorbidity Index (CCI)
3. Patient Reported Outcomes-Common Terminology for Adverse Events (PRO-CTCAE)
4. Adverse Event for Mucositis
5. Adverse Event for Nausea
6. Adverse Event for Vomiting
7. Adverse Event for Constipation
8. Adverse Event for Diarrhea
9. Adverse Event for Dyspnea
10. Adverse Event for Cough
11. Adverse Event for Acneiform Rash
12. Adverse Event for Maculo-Papular Rash
13. Adverse Event for Pain
14. Adverse Event for Fever
15. Nursing Perception of Telehealth Survey
16. Feasibility of Intervention Measure (FIM). Nursing Perspective on the Feasibility of Utilizing Telehealth Technology Survey
17. Nursing Experience with Telehealth and Patients' Adverse Events Survey
18. Patient Feasibility Survey
19. Acceptability of Intervention Measure (AIM). Patient Experience with Accessibility Related to Telehealth Sessions
20. Patient Experience with Telehealth Survey
A single group repeated measures design was used to evaluate the effect of telehealth on patient outcomes and patient experience for up to four telehealth sessions and nursing staff perceptions of telehealth. Enrollment was limited to 21 participants, in order to limit the number of patients for a pilot study.
Telehealth sessions began within seven days after the initial treatment and occurred weekly during cycle one of the participant's Phase 1 protocol. Side effects assessed by nursing included mucositis, nausea, vomiting, constipation, diarrhea, dyspnea, cough, rash, pain and fever. Patients were also given the opportunity to address other symptoms.
Original research was required to establish validity of telehealth for managing adverse events, dose limiting toxicities of study medications, and enhancing safe clinical care with potentially meeting unmet patient needs when beginning an oncology Phase 1 clinical trial.
Data Collection tools included:
1. Data collection Table which includes variables, sources of data and timeframes
2. Charlson Comorbidity Index (CCI)
3. Patient Reported Outcomes-Common Terminology for Adverse Events (PRO-CTCAE)
4. Adverse Event for Mucositis
5. Adverse Event for Nausea
6. Adverse Event for Vomiting
7. Adverse Event for Constipation
8. Adverse Event for Diarrhea
9. Adverse Event for Dyspnea
10. Adverse Event for Cough
11. Adverse Event for Acneiform Rash
12. Adverse Event for Maculo-Papular Rash
13. Adverse Event for Pain
14. Adverse Event for Fever
15. Nursing Perception of Telehealth Survey
16. Feasibility of Intervention Measure (FIM). Nursing Perspective on the Feasibility of Utilizing Telehealth Technology Survey
17. Nursing Experience with Telehealth and Patients' Adverse Events Survey
18. Patient Feasibility Survey
19. Acceptability of Intervention Measure (AIM). Patient Experience with Accessibility Related to Telehealth Sessions
20. Patient Experience with Telehealth Survey
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: