Improving Informed Consent for Palliative Chemotherapy

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

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 Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer; Metastatic Pancreatic Cancer; Unresectable Pancreatic Cancer
• Intervention / Treatment: Other: Usual, standard-of-care informed consent for chemotherapy; Other: Investigational informed consent for chemotherapy

Detailed Description

Research indicates that many patients with advanced cancer receive palliative chemotherapy without sufficient understanding of its likely risks and benefits. In surveys, many patients receive palliative chemotherapy without expressing an understanding that cure is unlikely.

The root of this problem is undoubtedly complex, but may relate to gaps in communication and patient education about the risks and benefits of treatment. 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 trial is to test a suite of patient-centered videos and booklets to support informed consent for common chemotherapy regimens used to treat advanced gastrointestinal cancers. In this study, patients with metastatic colorectal cancer, locally advanced and metastatic pancreatic cancer considering treatment with first or second-line palliative chemotherapy were randomized to the usual process of chemotherapy informed consent, or usual care supplemented by access to the appropriate investigational chemotherapy informed consent video and booklet. Patients were surveyed at baseline, 2-weeks post-treatment initiation, and 3 months regarding their understanding of chemotherapy risks and benefits, decisional conflict, and other metrics of informed decision-making.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California at San Francisco
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Milford, Massachusetts, United States, 01757
      • Dana-Farber at Milford
    • South Weymouth, Massachusetts, United States, 02190
      • Dana-Farber at South Shore
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of advanced colorectal cancer with metastasis, locally advanced pancreatic cancer, or metastatic pancreatic cancer.
• Is considering treatment with 1st line or 2nd line chemotherapy
• Treating oncologist has recommended consideration of one or more of the regimens for which we have developed informed consent materials
• Age ≥ 21
• English proficiency (reading and speaking)

Exclusion Criteria:

• Significant delirium/dementia as judged by the treating physician
• Isolated liver metastases being evaluated for curative resection

In addition, caregivers of eligible patients will also be eligible to participate in the caregivers assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual informed consent; Study participant will receive usual, standard-of-care informed consent for chemotherapy materials.	Other: Usual, standard-of-care informed consent for chemotherapy; The enrolling site's institutional standard-of-care informed consent materials.
Experimental: Investigational informed consent; Study participant will receive investigational informed consent for chemotherapy materials that were developed by the study team.	Other: Investigational informed consent for chemotherapy; Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Accurate Understanding of Chemotherapy Benefits	Patients were asked "How likely do you think that chemotherapy is to cure your cancer?" with response options of not at all likely, a little likely, somewhat likely, very likely, and don't know. A response of "not at all likely" was considered accurate. All other responses, including don't know, were considered inaccurate.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Accurate Understanding of Chemotherapy Risks	Patients were asked to rate the likelihood that they would experience specific side effects as a result of the chemotherapy under consideration, with separate items for nausea/vomiting, diarrhea, neuropathy, and hair loss. Patients' responses were correlated to the known side effect profile of their chemotherapy regimen and coded as accurate or inaccurate.	2 weeks
Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy	Patients were asked "according to your doctor, what is the goal of the chemotherapy?" with the ability to choose any/all of the following response options: cure, control cancer growth, alleviate symptoms, prolong life, or other. Selecting either control cancer growth, and/or alleviate symptoms, and/or prolong life were defined as accurate understanding; "to cure" was considered inaccurate.	2 weeks
Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores	Decisional Conflict was assessed by a modified version of the 4 item SURE instrument of Legare at al which assesses whether patients 1) are sure of the best treatment option, 2) know the risks and benefits of their treatment options, 3) are clear about which risks and benefits matter to them, and 4) whether they have sufficient support to make their treatment decision. We expanded items 2 and 3 into four separate items assessing risks and benefits individually. Responses were summed, resulting in a scale of 0-6, where 0 indicates maximum conflict and 6 indicates no conflict	2 weeks
Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process	Achievement of preferred role in decision-making was assessed by the Control Preferences Scale; patients indicate the role they played in their treatment decision which is compared to their preferred role (assessed at baseline).	2 weeks
Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores	Satisfaction with communication during treatment decision-making process was assessed via 5 items from the Patient Assessment of Cancer Communication Experiences (PACE). Scores were averaged ("does not apply" excluded), creating a score of 1 to 4, with 4 being the most satisfied.	2 weeks
Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team		3 months
Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale	Decisional Regret was assessed at the 3-month survey using Brehaut's 5-item decisional regret scale, with scores ranging from 0-100, where 100 indicates maximal regret, and 0 indicates no regret.	3 months
Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment	Emotional distress was assessed via the emotional wellbeing subscale of the FACT-G. Scores range from 0-24, with higher scores being more desirable.	3 months
Patient-Reported Prognostic Understanding in Median Years	Prognostic understanding was assessed by asking patients about their understanding of the prognosis of the typical patient with their condition (<1 year, 1-2 years, 2- 3 years, 3-5 years, 5-10 years, >10 years). This measure was adapted from the CANCORS trial.	3 months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Patient-Centered Outcomes Research Institute; National Cancer Institute (NCI); Alliance for Clinical Trials in Oncology

Publications and helpful links

General Publications

• Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
• Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
• Weeks JC, Catalano PJ, Cronin A, Finkelman MD, Mack JW, Keating NL, Schrag D. Patients' expectations about effects of chemotherapy for advanced cancer. N Engl J Med. 2012 Oct 25;367(17):1616-25. doi: 10.1056/NEJMoa1204410.
• Mazor KM, Street RL Jr, Sue VM, Williams AE, Rabin BA, Arora NK. Assessing patients' experiences with communication across the cancer care continuum. Patient Educ Couns. 2016 Aug;99(8):1343-8. doi: 10.1016/j.pec.2016.03.004. Epub 2016 Mar 6.
• Legare F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M, O'Connor A. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010 Aug;56(8):e308-14.
• Enzinger AC, Uno H, McCleary N, Frank E, Sanoff H, Van Loon K, Matin K, Bullock A, Cronin C, Cibotti H, Bagley J, Schrag D. Effectiveness of a Multimedia Educational Intervention to Improve Understanding of the Risks and Benefits of Palliative Chemotherapy in Patients With Advanced Cancer: A Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1265-1270. doi: 10.1001/jamaoncol.2020.1921.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2015
• Primary Completion (Actual): September 27, 2017
• Study Completion (Actual): September 27, 2017

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: chemotherapy; communication; cancer; oncology; colorectal; video; education; metastatic; outcomes research; palliative; informed consent; patient-centered
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 15-143; CE-1304-6517 (Other Grant/Funding Number: PCORI); 1UG1CA189823-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If interested in obtaining data from this project, please contact PI Deb Schrag at deb_schrag@dfci.harvard.edu.
• IPD Sharing Time Frame: Data will become available after the completion of primary outcome analyses and for up to 10 years following.
• IPD Sharing Access Criteria: If interested in obtaining data from this project, please contact PI Deb Schrag at deb_schrag@dfci.harvard.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP