CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 216 enrolled
Drug / intervention
Investigational informed consent for chemotherapy +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02282722
NCT02282722N/ACompleted

Improving Informed Consent for Palliative Chemotherapy: Development of a Regimen-Specific Multi-Media Informed Consent Library To Promote Patient-Centered Decision-Making About Treatment of Advanced Gastrointestinal Cancers

Dana-Farber Cancer Institute·interventional·Posted Nov 4, 2014·Updated Oct 14, 2021

In Brief

A clinical study evaluating Investigational informed consent for chemotherapy and Usual, standard-of-care informed consent for chemotherapy for Metastatic Colorectal Cancer and 2 related conditions. Completed, enrolled 216 participants across 8 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 4, 2014
Enrollment StartJun 10, 2015
Primary CompletionSep 27, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.7 years ago

Interventions

Investigational informed consent for chemotherapyother

Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet.

Usual, standard-of-care informed consent for chemotherapyother

The enrolling site's institutional standard-of-care informed consent materials.