Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02282722 · ClinicalTrials.gov registry record · NA
Improving Informed Consent for Palliative Chemotherapy
A NA study of Metastatic Colorectal Cancer and Metastatic Pancreatic Cancer, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- NA
- Development phase
- 216
- Enrollment target
- 8
- Study locations
NCT02282722 is a NA study of Metastatic Colorectal Cancer and Metastatic Pancreatic Cancer that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 216 participants, above the 181-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (19% higher). The trial reports 8 study locations across 4 states.
The verdict
NCT02282722, a NA study of Metastatic Colorectal Cancer and Metastatic Pancreatic Cancer, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 216 participants
- Enrollment target
- 8
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 181-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (19% higher). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
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.
NCT02282722 reports 8 study locations spanning 4 distinct geographic areas - top geographies include Massachusetts, North Carolina, California.
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.
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).
Who is sponsoring clinical trial NCT02282722?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Metastatic Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial
RECRUITING · NA
-
Pressure-enabled Delivery in Radioembolization (TriNav Study)
ACTIVE NOT RECRUITING · NA
-
EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options
COMPLETED · NA
-
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
RECRUITING · Phase 2
-
Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)
RECRUITING · Phase 1
-
Trial of ProAgio in Advanced/Metastatic Colorectal Cancer
RECRUITING · Phase 1
Explore more on PlainTrial
Metastatic Colorectal Cancer
All registered trials for this condition
Metastatic Pancreatic Cancer
All registered trials for this condition
California
All trials with a study site in California
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.