Improving Informed Consent for Palliative Chemotherapy

NCT02282722 | Completed Results

• 3 other identifiers: 15-143CE-1304-65171UG1CA189823-01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Metastatic Colorectal Cancer; Metastatic Pancreatic Cancer; Unresectable Pancreatic Cancer

Keywords

cancer; palliative; chemotherapy; metastatic; colorectal; communication; informed consent; video; education; oncology; patient-centered; outcomes research

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of Patients With Accurate Understanding of Chemotherapy Risks

  2 weeks

• Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy

  2 weeks

• Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores

  2 weeks

• Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process

  2 weeks

• Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores

  2 weeks

Study Arms (2)

Usual informed consent

ACTIVE COMPARATOR

Study participant will receive usual, standard-of-care informed consent for chemotherapy materials.

Other: Usual, standard-of-care informed consent for chemotherapy

Investigational informed consent

EXPERIMENTAL

Study participant will receive investigational informed consent for chemotherapy materials that were developed by the study team.

Other: Investigational informed consent for chemotherapy

Interventions

Investigational informed consent for chemotherapy OTHER

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

Investigational informed consent

Usual, standard-of-care informed consent for chemotherapy OTHER

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

Usual informed consent

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (8)

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Dana-Farber at Milford

Milford, Massachusetts, 01757, United States

Location

Dana-Farber at South Shore

South Weymouth, Massachusetts, 02190, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Novant Health

Winston-Salem, North Carolina, 27103, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Related Publications (6)

• 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.

  PMID: 23094723 BACKGROUND

• Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.

  PMID: 9505581 BACKGROUND

• 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.

  PMID: 26979476 BACKGROUND

• 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.

  PMID: 20705870 BACKGROUND

• 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.

  PMID: 12926578 BACKGROUND

• 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.

  PMID: 32672806 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Pancreatic Neoplasms; Neoplasms; Neoplasm Metastasis; Communication

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Deb Schrag
• Organization: Dana-Farber Cancer Institute

deb_schrag@dfci.harvard.edu

617-582-8301

Study Officials

• Andrea Enzinger, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Population Sciences

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 4, 2014
• Study Start: June 10, 2015
• Primary Completion: September 27, 2017
• Study Completion: September 27, 2017
• Last Updated: October 14, 2021
• Results First Posted: February 7, 2018

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available after the completion of primary outcome analyses and for up to 10 years following.
• Access Criteria: If interested in obtaining data from this project, please contact PI Deb Schrag at deb\ schrag@dfci.harvard.edu.

Locations

US (8)