Malignant NeoplasmNCT07069868
Telehealth in an Ambulatory Oncology Phase I Clinical Trial Unit
A study testing Telehealth in people with Malignant Neoplasm, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Telehealth
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 24 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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:
- The Partners Patient Gateway Application
- Front facing camera
Who cannot join
- Adults who are unable to consent
- Individuals younger than 18 years old
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Telehealth as a Nursing Strategy for Monitoring Patients in an Ambulatory Oncology Phase I Clinical Trial Unit
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.
Read the 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:
- Data collection Table which includes variables, sources of data and timeframes
- Charlson Comorbidity Index (CCI)
- Patient Reported Outcomes-Common Terminology for Adverse Events (PRO-CTCAE)
- Adverse Event for Mucositis
- Adverse Event for Nausea
- Adverse Event for Vomiting
- Adverse Event for Constipation
- Adverse Event for Diarrhea
- Adverse Event for Dyspnea
- Adverse Event for Cough
- Adverse Event for Acneiform Rash
- Adverse Event for Maculo-Papular Rash
- Adverse Event for Pain
- Adverse Event for Fever
- Nursing Perception of Telehealth Survey
- Feasibility of Intervention Measure (FIM). Nursing Perspective on the Feasibility of Utilizing Telehealth Technology Survey
- Nursing Experience with Telehealth and Patients' Adverse Events Survey
- Patient Feasibility Survey
- Acceptability of Intervention Measure (AIM). Patient Experience with Accessibility Related to Telehealth Sessions
- Patient Experience with Telehealth Survey
- Conditions
- Malignant Neoplasm
- Being tested
- Telehealth
- Keywords
- telemedicine, nursing, Phase 1 oncology clinical trial
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelehealthOther
Also called Telemedicine
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measures were scored via a Linkert scale ranging from 1 to 5. The higher the score indicates acceptability. 1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree and 5 = completely agree. Acceptability was measured by patients and nurses to see if telehealth would be acceptable for patients and staff in a Phase 1 oncology clinical trial unit.
Measured: From enrollment to the end of cycle one which can be up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start12 Aug 2021
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah M. Melonas, R.N, Massachusetts General Hospital
- Investigators
- Deborah Melonas, RN, OCN, ASN, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069868
- Sponsor's protocol ID
- 2021P001318
- Status last verified
- Jun 2021
- First submitted
- 24 Jan 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth as a Nursing Strategy for Monitoring Patients in an Ambulatory Oncology Phase I Clinical Trial Unit
- ClinicalTrials.gov ID
- NCT07069868
- Acronym / sponsor ID
- 2021P001318
- Conditions
- Malignant Neoplasm
- Keywords
- telemedicine, nursing, Phase 1 oncology clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Data collection Table which includes variables, sources of data and timeframes
- Charlson Comorbidity Index (CCI)
- Patient Reported Outcomes-Common Terminology for Adverse Events (PRO-CTCAE)
- Adverse Event for Mucositis
- Adverse Event for Nausea
- Adverse Event for Vomiting
- Adverse Event for Constipation
- Adverse Event for Diarrhea
- Adverse Event for Dyspnea
- Adverse Event for Cough
- Adverse Event for Acneiform Rash
- Adverse Event for Maculo-Papular Rash
- Adverse Event for Pain
- Adverse Event for Fever
- Nursing Perception of Telehealth Survey
- Feasibility of Intervention Measure (FIM). Nursing Perspective on the Feasibility of Utilizing Telehealth Technology Survey
- Nursing Experience with Telehealth and Patients' Adverse Events Survey
- Patient Feasibility Survey
- Acceptability of Intervention Measure (AIM). Patient Experience with Accessibility Related to Telehealth Sessions
- Patient Experience with Telehealth Survey
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telehealth visit | Experimental | Other: TelehealthPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (4 listed)
- Adults who are unable to consent
- Individuals younger than 18 years old
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelehealthAlso: TelemedicineDuring 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. | Other | Telehealth visit |
Primary outcome
The study will be feasible as measured by the Feasibility of Intervention at study completion.
Time frame: From enrollment to the end of cycle one which can be up to 28 days.
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.
1 secondary outcome
The study will be acceptable as measured by the Acceptability of Intervention Measure at study completion.
Time frame: From enrollment to the end of cycle one which can be up to 28 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Melonas, RN, OCN, ASN principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth in people with Malignant Neoplasm, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study will be feasible as measured by the Feasibility of Intervention at study completion. (time frame: From enrollment to the end of cycle one which can be up to 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.