NCT07069868

Telehealth in an Ambulatory Oncology Phase I Clinical Trial Unit

Telehealth as a Nursing Strategy for Monitoring Patients in an Ambulatory Oncology Phase I Clinical Trial Unit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Telehealth	During cycle one, participants will be asked about fevers, mucositis, nausea, vomiting, constipation, diarrhea, dyspnea, cough, rash, pain and fever. Symptoms will be graded according to Common Terminology Criteria for Adverse Events. A new adverse event of grade one or higher will be reported to a provider. An adverse event grade two or higher above baseline and/or experiencing cancer related symptoms above baseline, the findings will be reported to a Provider.

Timeline

• Start date: 2021-08-12
• Primary completion: 2022-03-24
• Completion: 2022-03-24
• First posted: 2025-07-17
• Last updated: 2025-07-17

Locations

1 site across 1 country: United States