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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive Care Team Alert | Other | DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.
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| Active Care Team Alert | Other | DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Care Team Alert | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| ePRO Oral Response Rate | proportion of participants responding to at least 50% of ePRO oral questionnaires at 30 days | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| ePRO Oral Response Rate | proportion of participants responding to at least 50% of ePRO oral questionnaires at 60 days | 60 days |
| ePRO Oral Response Rate | proportion of participants responding to at least 50% of ePRO oral questionnaires at 90 days |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Nadine McCleary, MD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
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
Data can be shared no earlier than 1 year following the date of publication
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Hybrid type 3 implementation study
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| 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. |
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| 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) | 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 | 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 | 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 | 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 | 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 | 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 | 90 Days |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |