Results Summary

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.

Final Research Report

View this project's final research report.

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 -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

Project Information

Deborah Schrag, MD, MPH
Dana-Farber Cancer Institute
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

Key Dates

September 2013
June 2018

Study Registration Information


Has Results
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Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
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Last updated: January 25, 2023