Oral Cancer Directed TherapyNCT03858712
EHR-embedded OCDT in Breast or GI Cancer
A study testing Active Care Team Alert and Passive Care Team Alert in people with Oral Cancer Directed Therapy and Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This is research study is for participants with advanced breast or gastrointestinal cancer who have been taking oral chemotherapy medication (Oral Cancer Directed Therapy). This study is to help researchers better understand gaps in assessing oral chemotherapy patient toxicity at home, adherence to treatment and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer Directed Therapy, Breast Cancer, Gastrointestinal Cancer
- What is being tested?
- Active Care Team Alert and Passive Care Team Alert
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2019to 23 Nov 2021
- 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
- Adult age 18 or older
- Male or Female
- Scheduled visit at DF/HCC within the BOC or GCC
- Diagnosis of advanced breast cancer or gastrointestinal cancer
- Prescribed any OCDT within prior 5 days of screening
- English as the primary language (as documented in the EHR, written or spoken, and patient interpreter needed flag = no)
Show all 9Show fewer
- Mobile number listed in EHR to allow participation in ePP portion of the study
- Women of any pregnancy status
- Patients diagnosed with an advanced cancer will be eligible to participate in the study until discontinuation of OCDT or death, whichever occurs first
Who cannot join
- Adults unable to provide verbal consent
- Pediatric patients
- Patients without access to a electronic device (including tablet, computer, aptop or smartphone)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Nonrandomized Phase II Hybrid Type 3 Implementation Study: Feasibility and Acceptance of an EHR-embedded Oral Cancer Directed Therapy Toxicity and Adherence Program for Patients With Breast or Gastrointestinal Cancer
This is research study is for participants with advanced breast or gastrointestinal cancer who have been taking oral chemotherapy medication (Oral Cancer Directed Therapy). This study is to help researchers better understand gaps in assessing oral chemotherapy patient toxicity at home, adherence to treatment and integrate toxicity/adherence reporting.
Read the detailed description
For patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.
- Participants will complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice
- Participants between clinic visits, will be asked to complete the oral weekly survey at home via the mobile or web based patient portal. The survey can be completed on a computer, tablet or smartphone at home or on a tablet at the time of scheduled visit.
- The first 100 participants to complete the survey will receive a passive care team alert for responses (per DFHCC policy)
- The second 100 participants to complete the survey will receive an active care team alert for responses.
- Being tested
- Active Care Team Alert, Passive Care Team Alert
- Keywords
- Oral Cancer Directed Therapy, Breast Cancer, Gastrointestinal Cancer, oral chemotherapy
- Medical subject headings
- Breast Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Care Team AlertOther
- Active care team alert via office practice nurse monitoring of ePRO oral responses scored at 3, indicating moderate-severe (grade ≥3) toxicity.
Office practice nurses will monitor ePRO oral responses and respond to those scored at 3 per disease center symptom management protocol.
The ePRO oral responses from the remaining participants will additionally be monitored by office practice nurses who will respond to ePRO responses with scores of 3, indicating a moderate-severe toxicity (grade 3 or higher).
Passive Care Team AlertOther
Primary care teams are assigned an EHR inBasket pool through which PP messages are delivered. Providers will be responsible for reviewing ePRO responses via inBasket, selecting "mark as reviewed" button as mandated for all clinical messages within 48 hours per policy.
| Study group | Role | What they receive |
|---|---|---|
| Passive Care Team Alert | Other | DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.
* Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice
* ePRO Home: -- ePRO oral between visits at home.
* Passive care team alert -- EHR inBasket notification Receives: Other: Passive Care Team Alert |
| Active Care Team Alert | Other | DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.
* Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice
* ePRO Home: -- ePRO oral between visits at home.
* Active care team alert -- practice nurse monitoring of ePRO home responses score = 3 indicating a moderate-severe toxicity (grade 3 or higher Receives: Other: Active Care Team Alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
ePRO Oral Response Rate
proportion of participants responding to at least 50% of ePRO oral questionnaires at 30 days
Measured: 30 days
Secondary outcomes (9)
ePRO Oral Response Rate
proportion of participants responding to at least 50% of ePRO oral questionnaires at 60 days
Measured: 60 days
ePRO Oral Response Rate
proportion of participants responding to at least 50% of ePRO oral questionnaires at 90 days
Measured: 90 days
Average number of ePRO oral questionnaires completed per week
average number of ePRO oral questionnaires completed per week until discontinuation of OCDT or end of study (whichever occurs first)
Measured: 90 Days
Proportion of Participants reporting ePRO grade 3+ toxicity
proportion of participants reporting grade 3+ toxicity on at least one ePRO oral questionnaire among participants who responded to at least one ePRO oral questionnaire
Measured: 90 Days
Proportion of Participants with an ePRO Intervention
proportion of participants who were called by an office practice nurse for toxicity, had an OCDT dose modification, urgent clinic visit, ED visit or unplanned hospitalization among participants who responded to at least one ePRO oral questionnaire
Measured: 90 Days
Participant Report of OCDT Frequency
proportion of participants who reported missing >20% of prescribed OCDT doses for reasons other than toxicity on at least one ePRO oral report among participants who responded to at least one ePRO oral questionnaire; measured by participant weekly report of dates and time (AM, PM) of missed doses of the prescribed OCDT regimen
Measured: 90 Days
Participant Report of OCDT Frequency
Among participant who self-reported missing ≥20%/<20% of prescribed OCDT doses via ePRO oral, the proportion for whom EHR prescriptions also indicated non-adherence/adherence; EHR prescriptions measured by Proportion of Days Covered (PDC) = proportion of days covered by OCDT prescription claims divided by 30 days
Measured: 30 Days
ePRO oral willingness
proportion of participants reporting that they were willing or very willing to use ePRO oral again in the future among participants who responded to at least one ePRO oral questionnaire
Measured: 90 Days
ePRO oral ease of use
Proportion of participants reporting that ePRO oral was either easy or very easy to use among participants who responded to at least one ePRO oral questionnaire
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start13 Mar 2019
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cancer Directed TherapyStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Hybrid type 3 implementation study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine McCleary MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Nadine McCleary, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858712
- Sponsor's protocol ID
- 18-571
- Status last verified
- May 2022
- First submitted
- 27 Feb 2019
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonrandomized Phase II Hybrid Type 3 Implementation Study: Feasibility and Acceptance of an EHR-embedded Oral Cancer Directed Therapy Toxicity and Adherence Program for Patients With Breast or Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT03858712
- Acronym / sponsor ID
- 18-571
- Keywords
- Oral Cancer Directed Therapy, Breast Cancer, Gastrointestinal Cancer, oral chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 1 Mar 2019 (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.
This is research study is for participants with advanced breast or gastrointestinal cancer who have been taking oral chemotherapy medication (Oral Cancer Directed Therapy). This study is to help researchers better understand gaps in assessing oral chemotherapy patient toxicity at home, adherence to treatment and integrate toxicity/adherence reporting.
Detailed description
For patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.
- Participants will complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice
- Participants between clinic visits, will be asked to complete the oral weekly survey at home via the mobile or web based patient portal. The survey can be completed on a computer, tablet or smartphone at home or on a tablet at the time of scheduled visit.
- The first 100 participants to complete the survey will receive a passive care team alert for responses (per DFHCC policy)
- The second 100 participants to complete the survey will receive an active care team alert for responses.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid type 3 implementation study
| Arm | Type | Receives |
|---|---|---|
| Passive Care Team Alert | Other | Other: Passive Care Team AlertDFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy. * Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice * ePRO Home: -- ePRO oral between visits at home. * Passive care team alert -- EHR inBasket notification |
| Active Care Team Alert | Other | Other: Active Care Team AlertDFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy. * Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice * ePRO Home: -- ePRO oral between visits at home. * Active care team alert -- practice nurse monitoring of ePRO home responses score = 3 indicating a moderate-severe toxicity (grade 3 or higher |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult age 18 or older
- Male or Female
- Scheduled visit at DF/HCC within the BOC or GCC
- Diagnosis of advanced breast cancer or gastrointestinal cancer
- Prescribed any OCDT within prior 5 days of screening
Key exclusion criteria (3 listed)
- Adults unable to provide verbal consent
- Pediatric patients
- Patients without access to a electronic device (including tablet, computer, aptop or smartphone)
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 |
|---|---|---|
| Active Care Team Alert2) Active care team alert via office practice nurse monitoring of ePRO oral responses scored at 3, indicating moderate-severe (grade ≥3) toxicity. Office practice nurses will monitor ePRO oral responses and respond to those scored at 3 per disease center symptom management protocol. The ePRO oral responses from the remaining participants will additionally be monitored by office practice nurses who will respond to ePRO responses with scores of 3, indicating a moderate-severe toxicity (grade 3 or higher). | Other | Active Care Team Alert |
| Passive Care Team AlertPrimary care teams are assigned an EHR inBasket pool through which PP messages are delivered. Providers will be responsible for reviewing ePRO responses via inBasket, selecting "mark as reviewed" button as mandated for all clinical messages within 48 hours per policy. | Other | Passive Care Team Alert |
Primary outcome
ePRO Oral Response Rate
Time frame: 30 days
proportion of participants responding to at least 50% of ePRO oral questionnaires at 30 days
9 secondary outcomes
ePRO Oral Response Rate
Time frame: 60 days
ePRO Oral Response Rate
Time frame: 90 days
Average number of ePRO oral questionnaires completed per week
Time frame: 90 Days
Proportion of Participants reporting ePRO grade 3+ toxicity
Time frame: 90 Days
Proportion of Participants with an ePRO Intervention
Time frame: 90 Days
Participant Report of OCDT Frequency
Time frame: 90 Days
Participant Report of OCDT Frequency
Time frame: 30 Days
ePRO oral willingness
Time frame: 90 Days
ePRO oral ease of use
Time frame: 90 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 12 May 2022.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Related trials for Oral Cancer Directed Therapy
RecruitingPhase 2
Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial
Oral Cavity Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8
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.
Nadine McCleary, MD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Care Team Alert and Passive Care Team Alert in people with Oral Cancer Directed Therapy and Breast Cancer, run by Dana-Farber Cancer Institute 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 9 inclusion and 3 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 12 May 2022. 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?
ePRO Oral Response Rate (time frame: 30 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 12 May 2022.