Metastatic Colorectal CancerNCT02282722
Improving Informed Consent for Palliative Chemotherapy
A study testing Investigational informed consent for chemotherapy and Usual, standard-of-care informed consent for chemotherapy in people with Metastatic Colorectal Cancer and Metastatic Pancreatic Cancer, run by Dana-Farber Cancer Institute at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer
- What is being tested?
- Investigational informed consent for chemotherapy and Usual, standard-of-care informed consent for chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Jun 2015to 27 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Dana-Farber at Milford
Milford, Massachusetts, 01757
Virginia Commonwealth University
Richmond, Virginia, 23284
University of California at San Francisco
San Francisco, California, 94143
Dana-Farber at South Shore
South Weymouth, Massachusetts, 02190
Novant Health
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer
- Being tested
- Investigational informed consent for chemotherapy, Usual, standard-of-care informed consent for chemotherapy
- Keywords
- cancer, palliative, chemotherapy, metastatic, colorectal, communication, informed consent, video, education, oncology, patient-centered, outcomes research
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms, Neoplasms, Neoplasm Metastasis, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational informed consent for chemotherapyOther
Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet.
Usual, standard-of-care informed consent for chemotherapyOther
The enrolling site's institutional standard-of-care informed consent materials.
| Study group | Role | What they receive |
|---|---|---|
| Usual informed consent | Active comparator | Study participant will receive usual, standard-of-care informed consent for chemotherapy materials. Receives: 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. Receives: Other: Investigational informed consent for chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 2 weeks
Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study start10 Jun 2015
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Alliance for Clinical Trials in Oncology, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Andrea Enzinger, Dana-Farber Cancer Institute
- Investigators
- Andrea Enzinger, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282722
- Sponsor's protocol ID
- 15-143
- Other IDs
- CE-1304-6517, 1UG1CA189823-01
- Status last verified
- Sep 2021
- First submitted
- 27 Oct 2014
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: If interested in obtaining data from this project, please contact PI Deb Schrag at deb\_schrag@dfci.harvard.edu.
Publications
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.
PubMed 23094723Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
PubMed 9505581Mazor 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.
PubMed 26979476Legare 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.
PubMed 20705870Brehaut 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.
PubMed 12926578Enzinger 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.
PubMed 32672806
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02282722
- Acronym / sponsor ID
- 15-143
- Conditions
- Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer
- Keywords
- cancer, palliative, chemotherapy, metastatic, colorectal, communication, informed consent, video
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Alliance for Clinical Trials in Oncology, National Cancer Institute (NCI)
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Posted 7 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual informed consent | Active comparator | Other: Usual, standard-of-care informed consent for chemotherapyStudy participant will receive usual, standard-of-care informed consent for chemotherapy materials. |
| Investigational informed consent | Experimental | Other: Investigational informed consent for chemotherapyStudy participant will receive investigational informed consent for chemotherapy materials that were developed by the study team. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational informed consent for chemotherapyInvestigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet. | Other | Investigational informed consent |
| Usual, standard-of-care informed consent for chemotherapyThe enrolling site's institutional standard-of-care informed consent materials. | Other | Usual informed consent |
Primary outcome
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.
9 secondary outcomes
Number of Patients With Accurate Understanding of Chemotherapy Risks
Time frame: 2 weeks
Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy
Time frame: 2 weeks
Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores
Time frame: 2 weeks
Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process
Time frame: 2 weeks
Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores
Time frame: 2 weeks
Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team
Time frame: 3 months
Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale
Time frame: 3 months
Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment
Time frame: 3 months
Patient-Reported Prognostic Understanding in Median Years
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23094723Weeks 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.
- Background: PubMed 9505581Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
- Background: PubMed 26979476Mazor 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.
- Background: PubMed 20705870Legare 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.
- Background: PubMed 12926578Brehaut 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.
- Derived from this study: PubMed 32672806Enzinger 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.
- Individual participant dataSharing planned: Yes. If interested in obtaining data from this project, please contact PI Deb Schrag at deb_schrag@dfci.harvard.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Enzinger, MD principal investigator
Dana-Farber Cancer Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational informed consent for chemotherapy and Usual, standard-of-care informed consent for chemotherapy in people with Metastatic Colorectal Cancer and Metastatic Pancreatic Cancer, run by Dana-Farber Cancer Institute at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Accurate Understanding of Chemotherapy Benefits (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02282722, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.