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Improving Informed Consent for Palliative Chemotherapy

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ClinicalTrials.gov Identifier: NCT02282722
Recruitment Status : Completed
First Posted : November 4, 2014
Results First Posted : February 7, 2018
Last Update Posted : October 22, 2018
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Deborah Schrag, MD, Dana-Farber Cancer Institute

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.


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Metastatic Pancreatic Cancer Unresectable Pancreatic Cancer Other: Investigational informed consent for chemotherapy Other: Usual, standard-of-care informed consent for chemotherapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : December 2013
Actual Primary Completion Date : September 27, 2017
Actual Study Completion Date : September 27, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of Patients With Accurate Understanding of Chemotherapy Benefits [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Number of Patients With Accurate Understanding of Chemotherapy Risks [ Time Frame: 2 weeks ]
    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. Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy [ Time Frame: 2 weeks ]
    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.

  3. Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores [ Time Frame: 2 weeks ]
    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

  4. Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process [ Time Frame: 2 weeks ]
    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).

  5. Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores [ Time Frame: 2 weeks ]
    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.

  6. Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team [ Time Frame: 3 months ]
  7. Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale [ Time Frame: 3 months ]
    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.

  8. Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment [ Time Frame: 3 months ]
    Emotional distress was assessed via the emotional wellbeing subscale of the FACT-G. Scores range from 0-24, with higher scores being more desirable.

  9. Patient-Reported Prognostic Understanding in Median Years [ Time Frame: 3 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282722


Locations
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United States, California
University of California at San Francisco
San Francisco, California, United States, 94143
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana-Farber at Milford
Milford, Massachusetts, United States, 01757
Dana-Farber at South Shore
South Weymouth, Massachusetts, United States, 02190
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Novant Health
Winston-Salem, North Carolina, United States, 27103
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
Dana-Farber Cancer Institute
Patient-Centered Outcomes Research Institute
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Deborah Schrag, MD MPH Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by Deborah Schrag, MD, Dana-Farber Cancer Institute:

Publications:
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Responsible Party: Deborah Schrag, MD, Chief, Division of Population Sciences, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02282722     History of Changes
Other Study ID Numbers: 15-143
CE-1304-6517 ( Other Grant/Funding Number: PCORI )
1UG1CA189823-01 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2014    Key Record Dates
Results First Posted: February 7, 2018
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: If interested in obtaining data from this project, please contact PI Deb Schrag at deb_schrag@dfci.harvard.edu.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
Keywords provided by Deborah Schrag, MD, Dana-Farber Cancer Institute:
cancer
palliative
chemotherapy
metastatic
colorectal
communication
informed consent
video
education
oncology
patient-centered
outcomes research
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases