Culturally Adapting an Intervention to Increase Genetic Testing in African American Cancer Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-79
SponsorBarbara Ann Karmanos Cancer Institute

About this trial

The goal of this clinical trial is to culturally adapt an educational genetic counseling intervention to increase the uptake in genetic counseling and testing among African Americans at risk for heredity cancers. With the help of community stakeholders and clinical genetic professionals the investigators will:

* adapt and refine a culturally relevant online educational genetic counseling program for at-risk African Americans * Test the effects of the educational program * collaborate with community leaders and clinical genetic professionals to translate study findings, develop a road map for dissemination to the community, and identify barriers to prepare for future trials.

Participants from Detroit Research on Cancer Survivor group will be offered enrollment. Once consent is obtained, questionnaires will be completed before an online genetic counselling intervention immediately after, and at 3 months

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants enrolled in Detroit Research on Cancer Survivors (Detroit ROCS)

Diagnosis of Primary Breast, prostate, or colorectal cancer on or after 1/1/2013

have received or currently receiving care at Karmanos Cancer Institute

meet one or more of the National Comprehensive Cancer Network (NCCN) guidelines for cancer genetic testing as described below

Disqualifiers

Previous genetic counseling and/or testing

Trial design

Design model

Single group

Treatments tested in this trial

  • Culturally adapted Online Genetic Counseling and Testing Information

    Behavioral

    Testing the effects of the educational intervention designed to increase the uptake of genetic counseling testing among at-risk African American survivors

Treatment groups

85 Participants
are divided into 1 treatment group
Group A: Online Culturally adapted Genetic Counseling InformationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Uptake of genetic counseling and genetic testing

One item question will ask whether participants have participated in genetic counseling and genetic testing (Yes or No)

Time frame
3 month follow Up

Secondary outcomes

1

Intention to undergo genetic counseling and testing

This 2-item measure assesses participant's intentions to undergo genetic counseling and testing (Yes or No)

Time frame
1 day Pre Intervention to 1 day Post Intervention
2

Sharing Your Results

This author-developed 3-item measure assesses the extent to which participants shared information from (1) the video, (2) their counseling appointment, or (3) their testing results with their family. Each item is scored individually as binary (Yes or No) with yes=sharing and no=did not share.

Time frame
3 month follow up
3

Major Experiences of Discrimination

This 18-item measure assesses whether participants have had 9 major experiences of discrimination (e.g., getting employment, housing, medical care) happen to them (responses: 1=once, 2=2-3 times, 3=4+ times, or 0=never happened). Responses (range 0-27) are summed into an Experiences score with higher score = greater experiences of racism. If participants who respond (1, 2, 3), for any item, they are asked to report the last time this happened (1=past week, 2=past month, 3=past year, 4=more than a year ago). These responses are averaged to create a Frequency score (range 1-4), which is multiplied by the Experiences scores to obtain a Severity score (range 9-108) with higher scores = higher severity of major experiences of discrimination experiences. The Experiences and Severity scores will be assessed as moderators of change in the primary outcomes.

Time frame
1 day prior to intervention
4

Everyday Experiences of Discrimination

This 5-item scale measure assesses experience of discrimination that participants might experience on daily basis (e.g., poor service in a restaurant, getting harassed). Responses are (1=almost everyday, 2=at least once a week, 3=a few times a month, 4=a few times a year, 5=less than once a year, 6=never). Responses (range 5-30) are summed, and all items are when reverse scored, higher scores = greater experiences of everyday discrimination. This measure will be assessed as a moderator of change in the primary outcomes. For item with a score of 1-4, participants are asked to name the main reason for the discrimination (examples: ancestry or national origin, gender, race, age, religion, weight). This item is described qualitatively.

Time frame
1 day prior to intervention

Other outcomes

1

Age at enrollment (measured in years)

Covariate of the primary outcome

Time frame
1 day prior to intervention
2

PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety Scale

This 8-item measure of anxiety will be used as a covariate of the primary outcome. Responses are (1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Higher scores (mean range (1-5)=higher anxiety.

Time frame
1 day prior to intervention
3

PROMIS (Patient-Reported Outcomes Measurement Information System) Depression Scale

This 8-item measure of depression will be used as a covariate of the primary outcome. This 8-item measure of anxiety will be used as a covariate of the primary outcome. Responses are (1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Higher scores (mean range=1-5)=higher depression.

Time frame
1 day prior to intervention
4

Education (covariate of the primary outcome)

Categorical assessment of education. Descriptive responses are (1=Employed full time (including self-employed); 2=Employed part time; (including self-employed); 3=Homemaker; 4=Unemployed; 5=Retired; 6=Disability; 7=Other (specify); 8=Employed; not otherwise specified)

Time frame
1 day prior to intervention

Sponsors and contacts

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Barbara Ann Karmanos Cancer Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator