CancerNCT01772511
Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
An observational study of Cancer and Oncology Problem, run by Andrew Sch umacher at 2 sites in United States.
Trial summary
The purpose of this study is to assess patients' understanding of clinical trials and to help researchers understand which areas of the informed consent need better explanation for future cancer clinical trial patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Oncology Problem
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer clinic
Who may be able to join
- Patients > 18 years of age
- Patients are receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy
- Patients must have been consented in English to an oncology treatment clinical study
Who cannot join
- Not meeting all eligibility criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
About this study
Official title: BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
The purpose of this study is to assess patients' understanding of clinical trials and to help researchers understand which areas of the informed consent need better explanation for future cancer clinical trial patients.
Read the detailed description
Obtaining informed consent as part of a clinical study is a cornerstone of current day medical ethics; however, this has not always been the case. The development of the informed consent has been necessitated out of abuses committed in the name of medicine.
Informed consents have become increasing lengthy and complex. It is not unusual for an Oncology Clinical Research informed consent to be greater than 20 pages. Investigators will utilize the QuIC-A survey to evaluate patient understanding of the basic elements of informed consent required by federal regulations. The QuIC-A survey has been condensed from 20 questions to 14 questions by eliminating the 6 phase specific questions. The remaining 14 questions are designed irrespective of phase and address the basic elements of informed consent.
Investigators hypothesize that as informed consents have become more lengthy and complicated, in part due to required regulatory language and legal clauses inserted to protect the institution performing research, patient comprehension of the basic elements of informed consent has been hindered.
- Conditions
- Cancer, Oncology Problem
- Being tested
- Questionnaire
- Keywords
- questionnaire, prior therapy, prior study volunteer, prior study patient, cancer, oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
All patients entering on this trial will have been enrolled on an oncology clinical trial and are receiving active anti-cancer treatment on that study.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Patients will be asked by a member of the research team if they would like to participate in this study evaluating patients' comprehension of the informed consent for the oncology treatment study that they are participating in. Patients will be consented and will be told that, at their next clinical visit, they will be given the questionnaire to complete. They will be given the option to complete the questionnaire on site after being given the document or have the ability to mail the completed questionnaire into the research office once completed. If the questionnaire is not returned within 2-weeks, the participant will be approached again during their normal clinical visit and asked if they still wish to participate in this study. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of all elements of informed consent via questionnaire
Comprehension of the important elements of the informed consent forms using questionnaire
Measured: 1 month
Secondary outcomes (1)
Patient comprehension
Effectors of patient comprehension using questionnaire
Measured: every 6 months, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Sch umacher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Sch umacher, Brown University
- Investigators
- Andrew Schumacher, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772511
- Sponsor's protocol ID
- 274
- Status last verified
- Dec 2014
- First submitted
- 14 Jan 2013
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schumacher A, Sikov WM, Quesenberry MI, Safran H, Khurshid H, Mitchell KM, Olszewski AJ. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study. PLoS One. 2017 Feb 24;12(2):e0172957. doi: 10.1371/journal.pone.0172957. eCollection 2017.
PubMed 28235011
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
- ClinicalTrials.gov ID
- NCT01772511
- Acronym / sponsor ID
- 274
- Conditions
- Cancer, Oncology Problem
- Keywords
- questionnaire, prior therapy, prior study volunteer, prior study patient, cancer, oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Andrew Sch umacherUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess patients' understanding of clinical trials and to help researchers understand which areas of the informed consent need better explanation for future cancer clinical trial patients.
Detailed description
Obtaining informed consent as part of a clinical study is a cornerstone of current day medical ethics; however, this has not always been the case. The development of the informed consent has been necessitated out of abuses committed in the name of medicine.
Informed consents have become increasing lengthy and complex. It is not unusual for an Oncology Clinical Research informed consent to be greater than 20 pages. Investigators will utilize the QuIC-A survey to evaluate patient understanding of the basic elements of informed consent required by federal regulations. The QuIC-A survey has been condensed from 20 questions to 14 questions by eliminating the 6 phase specific questions. The remaining 14 questions are designed irrespective of phase and address the basic elements of informed consent.
Investigators hypothesize that as informed consents have become more lengthy and complicated, in part due to required regulatory language and legal clauses inserted to protect the institution performing research, patient comprehension of the basic elements of informed consent has been hindered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | Behavioral: QuestionnairePatients will be asked by a member of the research team if they would like to participate in this study evaluating patients' comprehension of the informed consent for the oncology treatment study that they are participating in. Patients will be consented and will be told that, at their next clinical visit, they will be given the questionnaire to complete. They will be given the option to complete the questionnaire on site after being given the document or have the ability to mail the completed questionnaire into the research office once completed. If the questionnaire is not returned within 2-weeks, the participant will be approached again during their normal clinical visit and asked if they still wish to participate in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer clinic
Key inclusion criteria (3 listed)
- Patients > 18 years of age
- Patients are receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy
- Patients must have been consented in English to an oncology treatment clinical study
Key exclusion criteria (1 listed)
- Not meeting all eligibility criteria
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 |
|---|---|---|
| QuestionnaireAll patients entering on this trial will have been enrolled on an oncology clinical trial and are receiving active anti-cancer treatment on that study. | Behavioural | Questionnaire |
Primary outcome
Understanding of all elements of informed consent via questionnaire
Time frame: 1 month
Comprehension of the important elements of the informed consent forms using questionnaire
1 secondary outcome
Patient comprehension
Time frame: every 6 months, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Derived from this study: PubMed 28235011Schumacher A, Sikov WM, Quesenberry MI, Safran H, Khurshid H, Mitchell KM, Olszewski AJ. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study. PLoS One. 2017 Feb 24;12(2):e0172957. doi: 10.1371/journal.pone.0172957. eCollection 2017.
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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.
Andrew Schumacher principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Oncology Problem, run by Andrew Sch umacher at 2 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 3 inclusion and 1 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 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Understanding of all elements of informed consent via questionnaire (time frame: 1 month). 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 NCT01772511, which also lists 1 linked publication.
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 27 Jan 2015.