NCT03858712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

March 13, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2021

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

2.7 years

First QC Date

February 27, 2019

Last Update Submit

May 11, 2022

Conditions

Oral Cancer Directed TherapyBreast CancerGastrointestinal CancerOral Chemotherapy

Keywords

Oral Cancer Directed TherapyBreast CancerGastrointestinal Canceroral chemotherapy

Outcome Measures

Primary Outcomes (1)

  • ePRO Oral Response Rate

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

    30 days

Secondary Outcomes (9)

  • ePRO Oral Response Rate

    60 days

  • ePRO Oral Response Rate

    90 days

  • Average number of ePRO oral questionnaires completed per week

    90 Days

  • Proportion of Participants reporting ePRO grade 3+ toxicity

    90 Days

  • Proportion of Participants with an ePRO Intervention

    90 Days

  • +4 more secondary outcomes

Study Arms (2)

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

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

Other: Active Care Team Alert

Interventions

Active Care Team AlertOTHER

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).

Active Care Team Alert
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.

Passive Care Team Alert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Nadine McCleary, MD, MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Hybrid type 3 implementation study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 1, 2019

Study Start

March 13, 2019

Primary Completion

November 23, 2021

Study Completion

November 23, 2021

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, 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
More information

Locations

US(1)