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Improving Informed Consent for Palliative Chemotherapy
NCT02282722 · View on ClinicalTrials.gov ↗
Study Summary
Patients are routinely asked to sign an "informed consent" document prior to starting chemotherapy, indicating they understand the risks and benefits of treatment. Although this could be a strategic moment to equip patients with information they need to make truly informed medical decisions, many patients and caregivers note that these conversations are less useful than they could be. The informed consent process and its associated documents suffer several limitations: 1) risks are emphasized over benefits; 2) educational materials focus on individual drugs instead of regimens; 3) information is presented in written instead of alternative written/audiovisual format; and 4) the patient perspective is lacking. The overarching objective of this project is to develop a library of communication tools for the most common chemotherapy regimens used to treat advanced gastrointestinal cancers. Tools will include video clips and written documents that can be readily distributed, modified, and customized. This toolkit will be crafted in collaboration with oncologists and patients living with gastrointestinal cancer and improves upon existing resources in several ways: 1) balanced discussion of benefits as well as risks, 2) focus on regimens rather than drugs, 3) use of both written and video format, and 4) inclusion of the patient perspective (e.g. video clips of patients describing their experience). A panel of oncologist and patient stakeholders will evaluate the acceptability of the tools. The investigators will then conduct a randomized clinical trial to demonstrate if the informed consent toolkit improves the quality of informed consent for palliative chemotherapy. If effective, the tools will be amenable to broad dissemination via patient accessible cancer education websites and oncology clinics.
Conditions Studied
Interventions
- OTHER Investigational informed consent for chemotherapy
- OTHER Usual, standard-of-care informed consent for chemotherapy
Study Locations (8)
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
- Dana-Farber Cancer Institute — Boston
- Dana-Farber at Milford — Milford
- Dana-Farber at South Shore — South Weymouth
North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill
- Novant Health — Winston-Salem
California
- University of California at San Francisco — San Francisco
Virginia
- Virginia Commonwealth University — Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2015-06-10 |
| Est. Completion | 2017-09-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02282722
The ClinicalTrials.gov registry entry for NCT02282722 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 819 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which Investigational informed consent for chemotherapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02282722 reports 8 study locations spanning 4 distinct geographic areas — top geographies include Massachusetts, North Carolina, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02282722 about?
NCT02282722 is a clinical study titled "Improving Informed Consent for Palliative Chemotherapy". Patients are routinely asked to sign an "informed consent" document prior to starting chemotherapy, indicating they understand the risks and benefits of treatment. Although this could be a strategic moment to equip patients with information they need to make truly informed medical decisions, many pa...
What is the current status of trial NCT02282722?
This trial is currently completed. It is a NA study. The enrollment target is 216 participants. The study started on 2015-06-10. Estimated completion is 2017-09-27.
What conditions does trial NCT02282722 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02282722?
The interventions under investigation include: Investigational informed consent for chemotherapy (OTHER), Usual, standard-of-care informed consent for chemotherapy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02282722?
This trial is sponsored by Dana-Farber Cancer Institute, which has 819 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02282722 being conducted?
This trial has 8 study locations across California, Massachusetts, North Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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