Telehealth in an Ambulatory Oncology Phase I Clinical Trial Unit

Mass General Brigham

Status: Completed

Conditions: Malignant Neoplasm

Treatments: Other: Telehealth

Study type: Interventional

Funder types: Other

Identifiers

NCT07069868

2021P001318

Details and patient eligibility

About

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.

Full 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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Telehealth visit

Experimental group

Description:

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.

Treatment:

Other: Telehealth