People s Expectations When Enrolling in a Phase I/II RS1 Ocular Gene Transfer Clinical Trial

ID: NCT02317354
Status: Completed
Phase: N/A
Start Date: December 13, 2014
First Submitted: December 13, 2014
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: National Eye Institute (NEI)
Location: United States
Conditions: Retinoschisis, X-Linked
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

Brief Summary

Background:

-X-linked retinoschisis (XLRS) is an inherited eye condition. Researchers want to learn more about how people with XLRS choose to take part in research studies. They hope to find ways to help other people make decisions about joining early phase trials

Objective:

-To learn more about how people think and feel about taking part in early phase research.

Eligibility:

-Adults age 18 or older with diagnosed XLRS. They must be eligible to be screened for a Phase I/II ocular gene transfer clinical trial.

Design:

- Participants will be screened for the XLRS gene transfer study. They will be interviewed:

- Eligible participants who join the study - before the gene transfer procedure, then 3 months and 12 months after it.

- Eligible participants who do not join the study - after their screening visit and 3 months and 12 months later.

- Participants who are screened but ineligible - after their screening visit.

- Participants who choose not to be screened - at the time they make the decision and 1 year later.

- Interviews will ask for the participants thoughts about the clinical trial and why they chose to take part or not. The interviews will be recorded.

- On the day of interview 1, participants will fill out a survey about their mood and personality.

- On the days of interviews 2 and 3, participants will fill out a survey about their mood.

- Interviews may be done in person or by phone. Surveys can be done online or through the mail. Or they can be done in person at the NIH Clinical Center.

Detailed Description

Objective: The objective of this study is to understand the factors that influence patient expectations when enrolling in an early-phase RS1 ocular gene transfer clinical trial and to assess the psychological impact of patient expectations over time.

Study Population: Up to 50 adults with X-linked retinoschisis who are eligible to be screened for a Phase I/II ocular gene transfer clinical trial will be included in this study. We hope to capture the experience of those actively engaged in the decision-making process who may choose not to participate in the clinical trial or who may receive gene transfer.

Design: This is a prospective qualitative interview study with quantitative questionnaires. Participation will involve up to three interviews with questionnaires over one year. Interviews may take place in person at the National Institutes of Health Clinical Center (NIH CC) or by telephone and will focus on how the interviewee came to the decision to participate (not to participate) in the early-phase ocular gene transfer trial. Interviews will be transcribed verbatim, coded by two independent coders, and analyzed thematically. Participants will also be asked to complete a questionnaire that measures dispositional optimism, resilience, and general mood states using instruments that have been shown to be valid and reliable in both the general population and in clinical samples. Information collected from these surveys will supplement information collected during the qualitative interview and will provide information about constructs that are difficult to assess during a brief interview.

Outcome Measures: The primary outcomes of this study include a description of what research participants expect when choosing to enroll in an early-phase clinical trial and a description of the psychological impact, over time, of having high expectations
Condition or disease Intervention/treatment Phase

Retinoschisis

X-Linked

N/A

Tracking Information

First Submitted DateDecember 13, 2014
Last Update Posted DateFebruary 22, 2018
Start DateDecember 13, 2014
Actual Completion DateNovember 20, 2017
Primary Completion DateNovember 20, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Desc. expectation pt enroll ct [Time Frame: Study Completion]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitlePeople s Expectations When Enrolling in a Phase I/II RS1 Ocular Gene Transfer Clinical Trial
Official TitlePatient Expectations When Enrolling in a Phase I/II RS1 Ocular Gene Transfer Clinical Trial
Brief Summary

Background:

-X-linked retinoschisis (XLRS) is an inherited eye condition. Researchers want to learn more about how people with XLRS choose to take part in research studies. They hope to find ways to help other people make decisions about joining early phase trials

Objective:

-To learn more about how people think and feel about taking part in early phase research.

Eligibility:

-Adults age 18 or older with diagnosed XLRS. They must be eligible to be screened for a Phase I/II ocular gene transfer clinical trial.

Design:

- Participants will be screened for the XLRS gene transfer study. They will be interviewed:

- Eligible participants who join the study - before the gene transfer procedure, then 3 months and 12 months after it.

- Eligible participants who do not join the study - after their screening visit and 3 months and 12 months later.

- Participants who are screened but ineligible - after their screening visit.

- Participants who choose not to be screened - at the time they make the decision and 1 year later.

- Interviews will ask for the participants thoughts about the clinical trial and why they chose to take part or not. The interviews will be recorded.

- On the day of interview 1, participants will fill out a survey about their mood and personality.

- On the days of interviews 2 and 3, participants will fill out a survey about their mood.

- Interviews may be done in person or by phone. Surveys can be done online or through the mail. Or they can be done in person at the NIH Clinical Center.

Detailed Description

Objective: The objective of this study is to understand the factors that influence patient expectations when enrolling in an early-phase RS1 ocular gene transfer clinical trial and to assess the psychological impact of patient expectations over time.

Study Population: Up to 50 adults with X-linked retinoschisis who are eligible to be screened for a Phase I/II ocular gene transfer clinical trial will be included in this study. We hope to capture the experience of those actively engaged in the decision-making process who may choose not to participate in the clinical trial or who may receive gene transfer.

Design: This is a prospective qualitative interview study with quantitative questionnaires. Participation will involve up to three interviews with questionnaires over one year. Interviews may take place in person at the National Institutes of Health Clinical Center (NIH CC) or by telephone and will focus on how the interviewee came to the decision to participate (not to participate) in the early-phase ocular gene transfer trial. Interviews will be transcribed verbatim, coded by two independent coders, and analyzed thematically. Participants will also be asked to complete a questionnaire that measures dispositional optimism, resilience, and general mood states using instruments that have been shown to be valid and reliable in both the general population and in clinical samples. Information collected from these surveys will supplement information collected during the qualitative interview and will provide information about constructs that are difficult to assess during a brief interview.

Outcome Measures: The primary outcomes of this study include a description of what research participants expect when choosing to enroll in an early-phase clinical trial and a description of the psychological impact, over time, of having high expectations

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
13
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Retinoschisis
X-Linked
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Not Available
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment13
Completion DateNovember 20, 2017
Eligibility Criteria: - INCLUSION CRITERIA:
Participants may be eligible to take part in this study if they:
- Are 18 years of age or older.
- Have a molecular diagnosis of XLRS and are eligible to be screened for a Phase I/II ocular gene transfer clinical trial.
- Are able to understand and comply with the procedures of this study.
EXCLUSION CRITERIA:
Participants may not be able to take part in this study if they:
- Have eye findings or other medical conditions that would preclude consideration for participation in a Phase I/II ocular gene transfer clinical trial.
- Are receiving experimental treatment for XLRS in another research study.
GenderMale
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02317354
Other Study ID Numbers
150041
15-EI-0041
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
National Eye Institute (NEI)
Collaborators
Not Available
Investigators
Principal Investigator
Amy E Turriff
National Eye Institute (NEI)