Studies
| Study First Submitted Date | 2020-09-09 |
| Study First Posted Date | 2020-09-14 |
| Last Update Posted Date | 2022-03-31 |
| Start Month Year | September 8, 2020 |
| Primary Completion Month Year | July 4, 2023 |
| Verification Month Year | March 2022 |
| Verification Date | 2022-03-31 |
| Last Update Posted Date | 2022-03-31 |
Detailed Descriptions
| Sequence: | 20797263 |
| 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. |
Facilities
| Sequence: | 200769634 |
| Status | Recruiting |
| Name | Mayo Clinic in Rochester |
| City | Rochester |
| State | Minnesota |
| Zip | 55905 |
| Country | United States |
Facility Contacts
| Sequence: | 28215062 |
| Facility Id | 200769634 |
| Contact Type | primary |
| Name | Kathryn Cook, BS |
| [email protected] | |
| Phone | 507-422-5154 |
Conditions
| Sequence: | 52365045 |
| Name | Cancer |
| Downcase Name | cancer |
Id Information
| Sequence: | 40297245 |
| Id Source | org_study_id |
| Id Value | 20-007236 |
Countries
| Sequence: | 42720292 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55808688 | Sequence: | 55808689 | Sequence: | 55808690 |
| Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
| Title | 6,000 word consent form | Title | 4,000 word consent form | Title | 2,000 word consent form |
| Description | 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. | Description | 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. | Description | 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. |
Interventions
| Sequence: | 52675684 | Sequence: | 52675685 | Sequence: | 52675686 |
| Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
| Name | 6,000 word consent form | Name | 4,000 word consent form | Name | 2,000 word consent form |
| Description | Mock consent form with consistent content in approximately 6,000 word length. | Description | Mock consent form with consistent content in approximately 4,000 word length. | Description | Mock consent form with consistent content in approximately 2,000 word length. |
Design Outcomes
| Sequence: | 178095419 |
| Outcome Type | primary |
| Measure | Decision to enroll |
| Time Frame | Through study completion, approximately 1 hour |
| Description | 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. |
Sponsors
| Sequence: | 48499811 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Mayo Clinic |
Overall Officials
| Sequence: | 29387563 |
| Role | Principal Investigator |
| Name | Aminah Jatoi, MD |
| Affiliation | Mayo Clinic |
Central Contacts
| Sequence: | 12057979 |
| Contact Type | primary |
| Name | Kathryn D Cook, BS |
| Phone | 507-422-5154 |
| [email protected] | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68413373 | Sequence: | 68413374 | Sequence: | 68413375 |
| Design Group Id | 55808688 | Design Group Id | 55808689 | Design Group Id | 55808690 |
| Intervention Id | 52675684 | Intervention Id | 52675685 | Intervention Id | 52675686 |
Eligibilities
| Sequence: | 30877202 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Patient-reported history of cancer Patient is able to read English Patient-reported age of 18 years or older Exclusion Criteria: None |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254075458 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
Designs
| Sequence: | 30622991 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Other |
| Time Perspective | |
| Masking | Triple |
| Subject Masked | True |
| Caregiver Masked | True |
| Investigator Masked | True |
Links
| Sequence: | 4403128 |
| Url | https://www.mayo.edu/research/clinical-trials |
| Description | Mayo Clinic Clinical Trials |
Responsible Parties
| Sequence: | 28989532 |
| Responsible Party Type | Principal Investigator |
| Name | Aminah Jatoi, M.D. |
| Title | Principal Investigator |
| Affiliation | Mayo Clinic |