Telehealth in an Ambulatory Oncology Phase I Clinical Trial Unit

NCT ID: NCT07069868

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-12
• Study Completion Date: 2022-03-24

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

Conditions

Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telehealth visit

Patients were approached to participate in up to four nursing telehealth visits during their cycle one Phase 1 oncology clinical trial. Nursing assessed for potential adverse events and dose limiting toxicities using the Common Terminology Criteria for Adverse Events. Previous education was reinforced for participants. If the participant was administering an oral study medication at home, dosing instructions were reviewed, and diary evaluated for proper administration and documentation.

Group Type: EXPERIMENTAL

Telehealth

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Telemedicine

Eligibility Criteria

Inclusion Criteria

• Cancer diagnosis
• Consented and registered to a Phase I oncology clinical trial
• Cycle one patient
• 18 years of age or older
• Willing to participate in weekly telehealth sessions during cycle one
• Patient Gateway account
• Zoom video application downloaded and installed
• A reliable internet connection
• A device with the following requirements

PC/Mac with:

1. Chrome or Firefox as an internet browser

2. Webcam

3. Microphone

4. Speakers or Headphones

iPhone/iPad/Android Device with:

1. The Partners Patient Gateway Application

2. Front facing camera

Exclusion Criteria

• Adults who are unable to consent
• Individuals younger than 18 years old
• Pregnant women
• Prisoners

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Deborah M. Melonas, R.N

Registered Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Melonas, RN, OCN, ASN

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2021P001318

Identifier Type: -

Identifier Source: org_study_id