CancerNCT04548063
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
A study testing 6,000 word consent form, 4,000 word consent form and 2,000 word consent form in people with Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are using mock consent forms to see if wordiness has any effect on patients' understanding and willingness to sign up for a cancer clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- 6,000 word consent form, 4,000 word consent form and 2,000 word consent form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 6 Nov 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patient-reported history of cancer
- Patient is able to read English
- Patient-reported age of 18 years or older
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Researchers are using mock consent forms to see if wordiness has any effect on patients' understanding and willingness to sign up for a cancer clinical trial.
Read the detailed description
This study will determine whether there is a relationship between wordiness of a consent form and whether or not the consent form helped the patient decide to enroll in a clinical trial. This study will also determine whether wordiness of a consent form is associated with patients' willingness to sign the consent form.
- Conditions
- Cancer
- Being tested
- 6,000 word consent form, 4,000 word consent form, 2,000 word consent form
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6,000 word consent formOther
Mock consent form with consistent content in approximately 6,000 word length.
4,000 word consent formOther
Mock consent form with consistent content in approximately 4,000 word length.
2,000 word consent formOther
Mock consent form with consistent content in approximately 2,000 word length.
| Study group | Role | What they receive |
|---|---|---|
| 6,000 word consent form | Experimental | Subjects who are receiving cancer therapy or have been treated for cancer in the past will be asked to review a mock consent form of approximately 6,000 words. Receives: Other: 6,000 word consent form |
| 4,000 word consent form | Experimental | Subjects who are receiving cancer therapy or have been treated for cancer in the past will be asked to review a mock consent form of approximately 4,000 words. Receives: Other: 4,000 word consent form |
| 2,000 word consent form | Experimental | Subjects who are receiving cancer therapy or have been treated for cancer in the past will be asked to review a mock consent form of approximately 2,000 words. Receives: Other: 2,000 word consent form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision to enroll
Number of participants to indicate on the self-reported patient questionnaire that the information provided in the consent form helped make a decision about whether or not to enroll in the trial. This is defined as a response of 1 or 2 on the Likert scale of 1=strongly agree and 5= strongly disagree for information in the consent form was helpful to the decision to join the study.
Measured: Through study completion, approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start8 Sep 2020
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aminah Jatoi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548063
- Sponsor's protocol ID
- 20-007236
- Status last verified
- Aug 2024
- First submitted
- 9 Sep 2020
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almodallal Y, Duong Q, Satele D, Novotny P, Cook KD, Chauhan C, Daiss MK, Le-Rademacher J, Looker S, Martin N, Smestad MF, Winham SJ, Mandrekar SJ, Jatoi A. Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms. JCO Oncol Pract. 2021 Oct;17(10):e1460-e1472. doi: 10.1200/OP.21.00071. Epub 2021 Jun 14.
PubMed 34125586Wieland J, Satele D, Almodallal Y, Novotny P, Pritzl SL, Mandrekar SJ, Jatoi A. Succinct Cancer Clinical Trial Consent Forms in Rural Patients With Cancer: A Secondary Analysis of a Randomized, Double-Blinded study. J Patient Exp. 2022 Jun 22;9:23743735221107242. doi: 10.1177/23743735221107242. eCollection 2022.
PubMed 35756962
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consent Forms in Cancer Research: Examining the Effect of Length on Readability
- ClinicalTrials.gov ID
- NCT04548063
- Acronym / sponsor ID
- 20-007236
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 14 Sep 2020 (actual)
- 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.
Researchers are using mock consent forms to see if wordiness has any effect on patients' understanding and willingness to sign up for a cancer clinical trial.
Detailed description
This study will determine whether there is a relationship between wordiness of a consent form and whether or not the consent form helped the patient decide to enroll in a clinical trial. This study will also determine whether wordiness of a consent form is associated with patients' willingness to sign the consent form.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6,000 word consent form | Experimental | Other: 6,000 word consent formSubjects who are receiving cancer therapy or have been treated for cancer in the past will be asked to review a mock consent form of approximately 6,000 words. |
| 4,000 word consent form | Experimental | Other: 4,000 word consent formSubjects who are receiving cancer therapy or have been treated for cancer in the past will be asked to review a mock consent form of approximately 4,000 words. |
| 2,000 word consent form | Experimental | Other: 2,000 word consent formSubjects who are receiving cancer therapy or have been treated for cancer in the past will be asked to review a mock consent form of approximately 2,000 words. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient-reported history of cancer
- Patient is able to read English
- Patient-reported age of 18 years or older
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| 6,000 word consent formMock consent form with consistent content in approximately 6,000 word length. | Other | 6,000 word consent form |
| 4,000 word consent formMock consent form with consistent content in approximately 4,000 word length. | Other | 4,000 word consent form |
| 2,000 word consent formMock consent form with consistent content in approximately 2,000 word length. | Other | 2,000 word consent form |
Primary outcome
Decision to enroll
Time frame: Through study completion, approximately 1 hour
Number of participants to indicate on the self-reported patient questionnaire that the information provided in the consent form helped make a decision about whether or not to enroll in the trial. This is defined as a response of 1 or 2 on the Likert scale of 1=strongly agree and 5= strongly disagree for information in the consent form was helpful to the decision to join the study.
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 29 Aug 2024.
- Background: PubMed 34125586Almodallal Y, Duong Q, Satele D, Novotny P, Cook KD, Chauhan C, Daiss MK, Le-Rademacher J, Looker S, Martin N, Smestad MF, Winham SJ, Mandrekar SJ, Jatoi A. Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms. JCO Oncol Pract. 2021 Oct;17(10):e1460-e1472. doi: 10.1200/OP.21.00071. Epub 2021 Jun 14.
- Background: PubMed 35756962Wieland J, Satele D, Almodallal Y, Novotny P, Pritzl SL, Mandrekar SJ, Jatoi A. Succinct Cancer Clinical Trial Consent Forms in Rural Patients With Cancer: A Secondary Analysis of a Randomized, Double-Blinded study. J Patient Exp. 2022 Jun 22;9:23743735221107242. doi: 10.1177/23743735221107242. eCollection 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Aminah Jatoi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6,000 word consent form, 4,000 word consent form and 2,000 word consent form in people with Cancer, run by Mayo Clinic at 1 site 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 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Decision to enroll (time frame: Through study completion, approximately 1 hour). 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 NCT04548063, which also lists 2 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 29 Aug 2024.