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EHR-embedded OCDT in Breast or GI Cancer

Primary Purpose

Oral Cancer Directed Therapy, Breast Cancer, Gastrointestinal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Care Team Alert
Passive Care Team Alert
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Oral Cancer Directed Therapy focused on measuring Oral Cancer Directed Therapy, Breast Cancer, Gastrointestinal Cancer, oral chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Passive Care Team Alert

Active Care Team Alert

Arm Description

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

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

Outcomes

Primary Outcome Measures

ePRO Oral Response Rate
proportion of participants responding to at least 50% of ePRO oral questionnaires at 30 days

Secondary Outcome Measures

ePRO Oral Response Rate
proportion of participants responding to at least 50% of ePRO oral questionnaires at 60 days
ePRO Oral Response Rate
proportion of participants responding to at least 50% of ePRO oral questionnaires at 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)
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
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
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
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
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
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

Full Information

First Posted
February 27, 2019
Last Updated
May 11, 2022
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03858712
Brief Title
EHR-embedded OCDT in Breast or GI Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer Directed Therapy, Breast Cancer, Gastrointestinal Cancer, Oral Chemotherapy
Keywords
Oral Cancer Directed Therapy, Breast Cancer, Gastrointestinal Cancer, oral chemotherapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Hybrid type 3 implementation study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive Care Team Alert
Arm Type
Other
Arm Description
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
Arm Title
Active Care Team Alert
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Active Care Team Alert
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Passive Care Team Alert
Intervention Description
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.
Primary Outcome Measure Information:
Title
ePRO Oral Response Rate
Description
proportion of participants responding to at least 50% of ePRO oral questionnaires at 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
ePRO Oral Response Rate
Description
proportion of participants responding to at least 50% of ePRO oral questionnaires at 60 days
Time Frame
60 days
Title
ePRO Oral Response Rate
Description
proportion of participants responding to at least 50% of ePRO oral questionnaires at 90 days
Time Frame
90 days
Title
Average number of ePRO oral questionnaires completed per week
Description
average number of ePRO oral questionnaires completed per week until discontinuation of OCDT or end of study (whichever occurs first)
Time Frame
90 Days
Title
Proportion of Participants reporting ePRO grade 3+ toxicity
Description
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
Time Frame
90 Days
Title
Proportion of Participants with an ePRO Intervention
Description
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
Time Frame
90 Days
Title
Participant Report of OCDT Frequency
Description
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
Time Frame
90 Days
Title
Participant Report of OCDT Frequency
Description
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
Time Frame
30 Days
Title
ePRO oral willingness
Description
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
Time Frame
90 Days
Title
ePRO oral ease of use
Description
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
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine McCleary, MD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
IPD Sharing URL
http://www.dfhcc.harvard.edu/crs-resources/ODQ_Documents/02_CT.GOV_CTRP/Guidance_on_Data_Sharing.pdf

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EHR-embedded OCDT in Breast or GI Cancer

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