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Completed

NCT Number: NCT03858712

EHR-embedded OCDT in Breast or GI 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.

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Key information

Conditions

Oral Cancer Directed Therapy Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Oral Chemotherapy Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Active Care Team Alert

Other
  • 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 Alert

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2019
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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