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| ID | Type | Description | Link |
|---|---|---|---|
| CE-1304-6517 | Other Grant/Funding Number | PCORI | |
| 1UG1CA189823-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Alliance for Clinical Trials in Oncology | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual informed consent | Active Comparator | Study participant will receive usual, standard-of-care informed consent for chemotherapy materials. |
|
| Investigational informed consent | Experimental | Study participant will receive investigational informed consent for chemotherapy materials that were developed by the study team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational informed consent for chemotherapy | Other | Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
In addition, caregivers of eligible patients will also be eligible to participate in the caregivers assessments.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Enzinger, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Francisco | San Francisco | California | 94143 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23094723 | Background | 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. | |
| 9505581 | Background | Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43. |
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If interested in obtaining data from this project, please contact PI Deb Schrag at deb_schrag@dfci.harvard.edu.
Data will become available after the completion of primary outcome analyses and for up to 10 years following.
If interested in obtaining data from this project, please contact PI Deb Schrag at deb_schrag@dfci.harvard.edu.
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216 participants were consented to this study. Of these, 16 were were not eligible to be randomized and 14 did not complete a baseline assessment. After consultations with the study statistician, these participants were intentionally excluded from our analytic cohort. Therefore, 186 participants are included in the participant flow module.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Usual Care Arm | Patients randomized to usual care informed consent materials. |
| FG001 | Patient Investigational Care Arm | Patients randomized to the investigational informed consent materials. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2017 |
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| Usual, standard-of-care informed consent for chemotherapy | Other | The enrolling site's institutional standard-of-care informed consent materials. |
|
| 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 |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Dana-Farber at Milford | Milford | Massachusetts | 01757 | United States |
| Dana-Farber at South Shore | South Weymouth | Massachusetts | 02190 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Novant Health | Winston-Salem | North Carolina | 27103 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | United States |
| 26979476 | 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. |
| 20705870 | 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. |
| 12926578 | 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. |
| 32672806 | Derived | 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. |
| 2-week Assessment |
|
| 3-month Assessment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Informed Consent | Study participant will receive usual, standard-of-care informed consent for chemotherapy materials. Usual, standard-of-care informed consent for chemotherapy: The enrolling site's institutional standard-of-care informed consent materials. |
| BG001 | Investigational Informed Consent | Study participant will receive investigational informed consent for chemotherapy materials that were developed by the study team. Investigational informed consent for chemotherapy: Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Live alone | Count of Participants | Participants |
| ||||||||||||||||||
| Education | Count of Participants | Participants |
| ||||||||||||||||||
| Diagnosis | Count of Participants | Participants |
| ||||||||||||||||||
| ECOG Performance Status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 3 months |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | 2 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | 2 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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). | Posted | Count of Participants | Participants | 2 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team | Posted | Count of Participants | Participants | 3 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Median | Inter-Quartile Range | years | 3 months |
|
|
Through study completion, an average of 3 months
All participants were monitored for adverse events throughout their time on the study. On average, participants were involved in the trial for 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Usual Care Arm | Patients randomized to usual care informed consent materials. | 0 | 94 | 0 | 94 | 0 | 94 |
| EG001 | Patient Investigational Care Arm | Patients randomized to the investigational informed consent materials. | 0 | 92 | 0 | 92 | 0 | 92 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deb Schrag | Dana-Farber Cancer Institute | 617-582-8301 | deb_schrag@dfci.harvard.edu |
| Oct 3, 2017 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D003142 | Communication |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| No |
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| Unknown |
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| High school graduate, or some college |
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| College degree or higher |
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| Unknown/missing |
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| Advanced pancreatic cancer |
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| 1 - Restricted in physically strenuous activity |
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| 2 - Ambulatory but unable to work |
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| 3 - Capable of limited self-care |
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| 4 - Completely disabled |
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| Unknown/Missing |
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| Did not answer |
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