Clinical trial · Interventional
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
NCT07069868CI-TRIAL-00092296completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Telehealth | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Telehealth visit
- 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.
- interventionNames
- Other: Telehealth
Primary outcomes (1)
- measure
- The study will be feasible as measured by the Feasibility of Intervention at study completion.
- timeFrame
- From enrollment to the end of cycle one which can be up to 28 days.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.