This project has results

Improving Informed Consent for Palliative Chemotherapy

Results Summary and Professional Abstract

Results Summary

Download Summary Español (pdf) Audio Recording (mp3)

What was the research about?

Palliative chemotherapy is a treatment for advanced cancer that isn’t curable. This treatment may help slow the cancer’s growth or help patients to feel fewer effects from cancer.

To get permission to use this treatment, doctors give patients an information sheet and a consent form to read and sign. But even after reading these materials, many patients don’t understand that palliative chemotherapy won’t cure their cancer.

In this study, the research team made a video and booklet for patients that explained the goals of treatment for advanced cancer. The team wanted to see if the video and booklet helped patients to better understand treatment goals compared with those who got only the usual forms.

What were the results?

The group that got the video and booklet reported that palliative chemotherapy would not cure their cancer just as often as the group that got the usual forms.

Patients who got the video and booklet understood more about the risks of palliative chemotherapy compared with those who received the usual forms. But the research team didn’t find differences between the two groups in

Knowing the goals of treatment
Feeling confident about their decision
Regretting their decision
Feeling satisfied with the talks they had with doctors about the treatment
Feeling emotional distress
Understanding the likely outcomes of their cancer

Who was in the study?

The study included 186 patients getting care at five hospitals. Of these patients, 87 percent were white, 9 percent were African American, and 4 percent were Asian or other races. In addition, 58 percent were men, and 58 percent had graduated from college. Patients had colorectal cancer or pancreatic cancer. The average age was 59.

What did the research team do?

The team made a booklet and a video about palliative chemotherapy. The booklet included a link to a website to watch the video. Patients in the video talked about getting treatment, its side effects, and the quality of their lives while having treatment. Doctors and nurses in the video talked about the purpose, benefits, risks, and side effects of treatment.

The research team asked patients to be part of the study when they were either making decisions about palliative treatment for their cancer or had started treatment in the past two weeks. After patients agreed to be in the study, the team assigned patients by chance to one of two groups. One group got the usual information sheet and form to give consent. The other group got the booklet with the link to the video along with the usual forms.

Patients filled out surveys at the start of the study, two weeks after deciding about having the treatment, and three months after the start of the study. The surveys included questions about what patients knew about the treatment goals and how they felt about making a decision.

Patients, caregivers, doctors, and nurses worked with the research team on many parts of this project, including making the video and booklet.

What were the limits of the study?

Not everyone in the group who got the booklet read it or watched the video. Results may be different if people receive regular reminders to read the booklet and watch the video. People in the study were mostly white, and more than half had graduated from college. The results might be different for other groups of people.

In the future, researchers could test different ways to get patients to read the booklet and watch the video. Future studies could also test the booklet and video with people from different backgrounds.

How can people use the results?

Researchers can use these results to find ways to help patients understand the goals of palliative chemotherapy when making decisions about treatment.

Professional Abstract

Objective

To compare the effectiveness of a new informed consent video and booklet about palliative chemotherapy in addition to the standard informed consent documents in providing patients with accurate expectations regarding treatment outcomes compared with standard informed consent documents alone

Study Design

Design Element	Description
Design	Randomized controlled trial
Population	186 patients with advanced colorectal or pancreatic cancer
Interventions/ Comparators	Informed consent video and booklet about palliative chemotherapy in addition to standard informed consent documents Standard informed consent documents alone (control)
Outcomes	Primary: proportion of patients at 3 months with accurate expectation of palliative chemotherapy benefits Secondary: understanding of treatment goals, understanding of chemotherapy risks, decisional conflict, decisional regret, satisfaction with communication during the treatment decision-making process, emotional distress, prognostic understanding
Timeframe	3-month follow-up for primary outcome

This randomized controlled trial compared the use of an informed consent video and booklet about palliative chemotherapy developed by the researchers for use in the informed consent process with standard informed consent documents among patients with advanced colorectal or pancreatic cancers.

Researchers recruited patients who were in the process of making palliative chemotherapy treatment decisions and patients who had started their first treatment within two weeks of study recruitment. Once patients consented to being part of this study, researchers randomized them to receive either the standard informed consent documents, including a consent form and information sheet, or the standard documents along with the new booklet, which included a link to the video. Patients in the video talked about their personal experiences with chemotherapy, including side effects, quality of life, coping strategies, and treatment benefits. Oncologists and nurses in the video talked about the purpose, benefits, and risks of palliative chemotherapy and how clinicians administer the treatment. The booklet included information similar to the video.

The study included 186 patients receiving care at five academic hospitals. Of these patients, 87% were white, 9% were African American, and 4% were Asian or other races. In addition, 58% were men, and 58% had a college degree or higher. Patients had colorectal cancer (64%) or pancreatic cancer (36%). The average age was 59.

Patients completed a survey at baseline, two weeks after their chemotherapy treatment decision, and again three months after baseline. The surveys included questions about what patients knew about treatment goals and how they felt about making a treatment decision.

Patients, caregivers, and oncology physicians and nurses worked with researchers throughout the study and helped develop the video and booklet.

Results

After three months, researchers did not find significant differences between the intervention and control groups in the proportion of patients with accurate expectations of chemotherapy benefits. At baseline, 47% of patients in the intervention group and 45% in the control group responded correctly that their chemotherapy was not curative; three months after baseline, 52% of patients in the intervention group and 57% in the control group responded that the chemotherapy was not curative.

Compared with patients in the control group, patients in the intervention group were more likely to have an accurate understanding of chemotherapy risks (p=0.05). Researchers did not find differences in any other secondary outcomes.

Limitations

Less than half of intervention group patients watched the informational video. Results may have been different if more patients completed the intervention. Most patients who enrolled in the study were white, and more than half had high educational attainment. Results may not be generalizable to other racial, ethnic, or sociodemographic groups.

Conclusions and Relevance

Among patients with advanced colorectal and pancreatic cancer, the video and companion booklet did not add to patients’ understanding of the purpose of palliative chemotherapy provided by the standard informed consent process.

Future Research Needs

Future research could focus on different approaches for administering the intervention or on alternative interventions for educating patients with colorectal or pancreatic cancer about the purpose and expected outcomes of palliative chemotherapy.

Final Research Report

View this project's final research report.

Journal Articles

Patient Education and Counseling

A stakeholder-driven approach to improve the informed consent process for palliative chemotherapy.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.

Reviewers’ comments and the investigator’s changes in response included the following:

The awardee justified the study design, in which patients were able to review study materials at their own convenience, outside the context of a doctor’s visit, factors which might have improved internal validity. The investigator explained that it did not feel appropriate to add the burden of viewing study materials when patients with noncurable cancer are in an emotionally charged doctor’s visit. By allowing patients to view materials on their own time, the investigator felt the study would better reflect real-world implementation of the intervention.
The awardee revised its presentation of results to clarify that although some comparisons reached statistical significance, most would not be considered significant because the p-value did not reach the conventional threshold of p<0.05.
The reviewers expressed concern that the research moved too quickly from developing the intervention to becoming a large effectiveness study, particularly given a lack of pilot data that would have helped establish what to consider as a clinically meaningful effect. The awardee countered that it estimated an appropriate effect size based on previous studies with similar populations. The investigator considered this practice an acceptable substitute for piloting the intervention in a feasibility study.

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator

Deborah Schrag, MD, MPH

Project Status

Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted

Project Title

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

Board Approval Date

September 2013

Project End Date

June 2018

Organization

Dana-Farber Cancer Institute

Year Awarded

2013

State

Massachusetts

Year Completed

2018

Project Type

Research Project

Health Conditions

Cancer

Colorectal Cancer

Intervention Strategies

Other Health Services Interventions
Technology Interventions
Training and Education Interventions

Populations

Racial/Ethnic Minorities
Low Health Literacy/Numeracy
Low Income
Older Adults

Funding Announcement

Assessment of Prevention, Diagnosis, and Treatment Options

Project Budget

$1,063,122

DOI - Digital Object Identifier

10.25302/7.2019.CE.13046517

Study Registration Information

HSRP20143516

NCT02282722

Page Last Updated:

February 20, 2020