Telehealth in an Ambulatory Oncology Phase I Clinical Trial Unit

NCT07069868 | Completed

• 1 other identifier: 2021P001318
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Keywords

telemedicine; nursing; Phase 1 oncology clinical trial

Outcome Measures

Primary Outcomes (1)

• The study will be feasible as measured by the Feasibility of Intervention at study completion.

  Measures were scored via a Linkert scale ranging from 1 to 5. The higher the score indicates feasibility. 1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree and 5 = completely agree. Feasibility was measured by patients and nurses to see if telehealth would be feasible if implemented in a Phase 1 oncology clinical trial unit.

  From enrollment to the end of cycle one which can be up to 28 days.

Secondary Outcomes (1)

• The study will be acceptable as measured by the Acceptability of Intervention Measure at study completion.

  From enrollment to the end of cycle one which can be up to 28 days.

Study Arms (1)

Telehealth visit

EXPERIMENTAL

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.

Other: Telehealth

Interventions

Telehealth 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.

Also known as: Telemedicine

Telehealth visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer diagnosis
• Consented and registered to a Phase I oncology clinical trial
• Cycle one patient
• 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:
• Chrome or Firefox as an internet browser
• Webcam
• Microphone
• Speakers or Headphones
• iPhone/iPad/Android Device with:

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Deborah Melonas, RN, OCN, ASN

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Model Details: A quasi-experimental study of weekly telehealth visits was conducted using a single-group repeated measures design for adults with cancer enrolled in cycle one Phase 1 clinical trials.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: July 17, 2025
• Study Start: August 12, 2021
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: July 17, 2025

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)