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EHR-embedded OCDT in Breast or GI Cancer

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ClinicalTrials.gov Identifier: NCT03858712
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Nadine McCleary MD, MPH, Dana-Farber Cancer Institute

Brief 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 integrate toxicity/adherence reporting.

Condition or disease Intervention/treatment Phase
Oral Cancer Directed Therapy Breast Cancer Gastrointestinal Cancer Oral Chemotherapy Other: Active Care Team Alert Other: Passive Care Team Alert Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Hybrid type 3 implementation study
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arm Intervention/treatment
Passive Care Team Alert

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
Other: Passive Care Team Alert
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.

Active Care Team Alert

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
Other: Active Care Team Alert

2) 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).





Primary Outcome Measures :
  1. ePRO Oral Response Rate [ Time Frame: 30 days ]
    proportion of participants responding to at least 50% of ePRO oral questionnaires at 30 days


Secondary Outcome Measures :
  1. ePRO Oral Response Rate [ Time Frame: 60 days ]
    proportion of participants responding to at least 50% of ePRO oral questionnaires at 60 days

  2. ePRO Oral Response Rate [ Time Frame: 90 days ]
    proportion of participants responding to at least 50% of ePRO oral questionnaires at 90 days

  3. Average number of ePRO oral questionnaires completed per week [ Time Frame: 90 Days ]
    average number of ePRO oral questionnaires completed per week until discontinuation of OCDT or end of study (whichever occurs first)

  4. Proportion of Participants reporting ePRO grade 3+ toxicity [ Time Frame: 90 Days ]
    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

  5. Proportion of Participants with an ePRO Intervention [ Time Frame: 90 Days ]
    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

  6. Participant Report of OCDT Frequency [ Time Frame: 90 Days ]
    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

  7. Participant Report of OCDT Frequency [ Time Frame: 30 Days ]
    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

  8. ePRO oral willingness [ Time Frame: 90 Days ]
    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

  9. ePRO oral ease of use [ Time Frame: 90 Days ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria

  • Adults unable to provide verbal consent
  • Pediatric patients
  • Patients without access to a electronic device (including tablet, computer, aptop or smartphone)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858712


Contacts
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Contact: Nadine McCleary, MD, MPH 617-632-6729 nj_mccleary@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Nadine McCleary, MD, MPH         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Nadine McCleary, MD, MPH Dana-Farber Cancer Institute

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Responsible Party: Nadine McCleary MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03858712     History of Changes
Other Study ID Numbers: 18-571
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
URL: http://www.dfhcc.harvard.edu/crs-resources/ODQ_Documents/02_CT.GOV_CTRP/Guidance_on_Data_Sharing.pdf

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nadine McCleary MD, MPH, Dana-Farber Cancer Institute:
Oral Cancer Directed Therapy
Breast Cancer
Gastrointestinal Cancer
oral chemotherapy

Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Mouth Neoplasms
Lip Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Mouth Diseases
Digestive System Diseases
Gastrointestinal Diseases
Stomatognathic Diseases
Lip Diseases