Health TrialsbyHealthPanel

Overcoming Barriers to Uptake of Cascade Screening

ConditionLynch Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

Lynch syndrome is a genetic condition that increases cancer risk. The public health impact of genetic testing for disease prevention hinges on cascade screening, which is the systematic identification and testing of blood relatives after a family member has been diagnosed with a genetic condition. Despite its importance in disease prevention, only half of first-degree relatives of individuals with Lynch syndrome undergo cascade screening. To address this gap, the study will pilot test an online version of Let's Talk, a novel intervention designed to support and promote cascade screening. This intervention tool is designed to support and encourage more family members to get screened. The purpose of this study aim is to assess the feasibility of the online Let's Talk tool in clinical use by examining implementation and effectiveness outcomes related to the use of the planning tool across three clinics at a large academic-affiliated medical center with patients (n=15) seen by one of five genetic counselors (n=5).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent obtained to participate in the study.

Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.

Age ≥ 18 years at the time of consent.

Written informed consent obtained to participate in the study.

Disqualifiers

The patient has already notified all relatives about their diagnosis with Lynch syndrome.

Genetic Counselor is not employed.

Trial design

Design model

Single group

Treatments tested in this trial

  • Let's Talk Genetics Providers

    Behavioral

    Providers will complete a brief pre-intervention survey and a short training on the Let's Talk tool. They will then help recruit eligible patients from genetics clinics who need cascade screening for Lynch syndrome. After the intervention, providers will complete post-intervention surveys and interviews.

  • Let's Talk Patients

    Behavioral

    Patients will complete a brief pre-intervention survey and receive access to the online Let's Talk toolkit for two months. The toolkit addresses key barriers to cascade screening for Lynch syndrome by building knowledge, confidence, and communication skills through simple, evidence-based activities. After two months, patients will complete a post-intervention survey and participate in a qualitative interview.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Genetic Counselor participantsExperimental treatment 1 intervention
Group B: Patient participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in patient knowledge

Change in patient knowledge will be measured by an online survey prior to and after the intervention. Knowledge will be measured using a 12-item knowledge scale developed by Bannon et al. (2014) covering topics such as hereditary basis of Lynch syndrome (LS), transmission pattern, risks of LS-related cancers, surveillance strategies, and prophylactic options. All items on the survey are of multiple-choice format and will be scored from 0-100% based on the proportion of correct answers. Change in patient knowledge across timepoints will be analyzed using a Wilcoxon signed rank test.

Time frame
2 months

Secondary outcomes

1

Let's Talk reach

Reach will be calculated as the proportion of individuals who provide informed consent among those approached for participation. This proportion will be calculated based on reports from the five participating genetic counselors.

Time frame
8 months
2

Let's Talk provider adoption

Adoption will be defined as the proportion of the five participating genetic providers who shared the intervention with at least one patient during the study period. This will be calculated by dividing the number of providers who report sharing the intervention with \>1 patient by the total number of participating providers (n=5).

Time frame
8 months
3

Let's Talk patient acceptability

Patient acceptability will be defined as patient satisfaction with the intervention. This will be evaluated using a four-item scale included in the post-intervention patient survey. Patients will indicate their level of agreement with four acceptability-related statements on a five-point Likert scale, adapted from Weiner et al. (2017), ranging from "Completely disagree" to "Completely agree".

Time frame
8 months
4

Let's Talk provider feasibility

Provider feasibility will examine the extent to which providers feel they can successfully share this tool with relevant patients in a clinical setting. This will be evaluated using a four-item scale included in the end-of-study provider survey. Providers will indicate their level of agreement with four feasibility-related statements on a five-point Likert scale, adapted from Weiner et al. (2017), ranging from "Completely disagree" to "Completely agree".

Time frame
8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UNC Lineberger Comprehensive Cancer Center

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Human Genome Research Institute (NHGRI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: