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.