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Telehealth in an Ambulatory Oncology Phase I Clinical Trial Unit

NCT07069868 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-07-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Deborah Melonas, RN, OCN, ASN · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-12
Primary Completion
2022-03-24
Completion
2022-03-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069868 on ClinicalTrials.gov