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| ID | Type | Description | Link |
|---|---|---|---|
| 1P01CA272239-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online Culturally adapted Genetic Counseling Information | Experimental | Culturally developed online Genetic counseling information will be provided. Questionnaires will be administered pre and post genetic counseling intervention as well as 3 months post intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 month follow Up |
| Measure | Description | Time Frame |
|---|---|---|
| Intention to undergo genetic counseling and testing | This 2-item measure assesses participant's intentions to undergo genetic counseling and testing (Yes or No) | 1 day Pre Intervention to 1 day Post Intervention |
| Sharing Your Results |
| Measure | Description | Time Frame |
|---|---|---|
| Age at enrollment (measured in years) | Covariate of the primary outcome | 1 day prior to intervention |
| 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. |
Inclusion Criteria:
Female breast
OR Prostate
OR Colorectal
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasminder Phalore, MPH | Contact | 313-576-9735 | phalorej@karmanos.org |
| Name | Affiliation | Role |
|---|---|---|
| Felicity WK Harper, Ph.D | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
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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.
| 3 month follow up |
| 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. | 1 day prior to intervention |
| 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. | 1 day prior to intervention |
| Interpersonal Processes of Care Survey | This 13-item scale is designed to measure race-specific perceptions of communication between patient and healthcare providers (e.g., compassion, discrimination, and disrespectful office space). Responses are (1=never, 2=rarely, 3=sometimes, 4=usually, 5=always). The first 9 items (mean range 1-5) with higher scores=higher levels of compassion and (reverse scored) lower discrimination. The next 4 items (mean range 1-5) with higher scores=higher disrespectful attitudes from office staff. The two subscales will be assessed as moderators of change in the primary outcomes | 1 day prior to intervention |
| Group-Based Medical Mistrust Scale | This 12-item scale was developed to measure race-based medical mistrust: the suspicion of mainstream health care systems and professionals and the treatment provided to individuals because they are African American. The items are scored with responses (1=strongly disagree, 2=disagree, 3=neither agree or disagree, 4=agree, 5=strongly agree). Higher scores (mean range 1-5)=higher levels of mistrust of providers. This measure will be assessed as a primary outcome of the intervention | 1 day prior to intervention |
| Perceived Access to Health Care Services | This 13-item, 4-point Likert-style scale was designed to measure perceptions of ability to get care, considering barriers such as cost, availability, and cultural fit. The scale includes items on cost and access to services. The responses are (1=strongly disagree., 2=disagree, 3=agree, 4=strongly agree) with a mean range of 1-4. Higher score=greater participation in cancer screening and a higher family income level. | 1 day prior to intervention |
| Perceived risk of carrying genetic mutation | This 1-item measure ("How likely do you think it is that you carry a genetic mutation that increases your risk for cancer?") assesses perceived risk of carrying a genetic mutation that increases risk for cancer. The item is scored (1=not at all to 5=extremely likely; range 1-5). Higher scores=higher perceived likelihood of carrying a genetic mutation. | 1 day Pre Intervention to 1 day Post Intervention |
| Attitudes about genetic counseling and testing | This 8-item scale is designed to measure positive and negative attitudes about the genetic counseling and testing process using the following 8 adjectives: worthwhile, worrying, reassuring, uncomfortable, wise, healthy, unpleasant, and important. Responses are (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Higher summed scores (range is 8-40)=more positive attitudes. | 1 day Pre Intervention to 1 day Post Intervention |
| Behavioral beliefs about genetic counseling | This 30-item scale measures genetic counseling-related beliefs and concerns across the following 6 subscales: "pros" of genetic counseling, "cons" of genetic counseling, competing concerns, cultural concerns, logistic concerns, and desire for more information. The responses are (1=strongly disagree, 2=moderately disagree, 3=neither agree nor disagree, 4=moderately agree, 5=strongly agree). Higher scores (range 15-75)=more positive beliefs. | 1 day Pre Intervention to 1 day Post Intervention |
| Perceived norms | This 10-item measure assesses injunctive and descriptive norms (5 items each) about genetic counseling. Responses are scored on a 5-point Likert scale (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Higher scores (range 1=25)=stronger perceived norms for each of the subscales ((injunctive norms and descriptive norms, respectively). | 1 day Pre Intervention to 1 day Post Intervention |
| Knowledge of Genetic Counseling | This 5-item scale is designed to evaluate an individual's basic knowledge of the genetic counseling process (e.g., How much have you read or heard about genetic counseling for: inherited disease? Cancer, in general?). Items are scored (1=very much to 7=not at all). (Reversed) Higher scores (mean range 1-7)=higher knowledge of genetic counseling. | 1 day Pre Intervention to 1 day Post Intervention |
| Perceived self-Efficacy | This 10-item measure assesses participant's perceived self-efficacy for pursuing genetic counseling if they were interested. Responses are (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Higher scores (mean range=1-5)=higher self efficacy for pursuing genetic counseling. | 1 day Pre Intervention to 1 day Post Intervention |
| Multidimensional Impact of Cancer Risk Assessment | This 25-item scale is designed to evaluate participant emotional responses after genetic testing, regardless of result, across 3 subscales (Distress, Uncertainty, and Positive Experiences-reverse scored). The responses are 0=never, 1=rarely, 3=sometimes, 5=often. Total summed score range=0-95. Higher scores=stronger emotional impact of testing results on the individual. The measure will be assessed as part of the intervention outcomes. | 3 month Follow Up |
| Cancer Family Impact | This 18-item scale is designed to measure the flow of information and communication about cancer in families, thoughts about family norms about cancer prevention, and the effects of cancer on families across 5 subscales (Flow: flow of information about cancer in families; Negative: negative effects of cancer on the family; Positive: positive effects of cancer on the family; Communicate: how families communicate with each other about cancer; and Norm: reaction to family norms about cancer prevention). The responses are (0=strongly disagree, 1=disagree, 2= neither agree or disagree, 3=agree 4= strongly agree). Higher total (range 0-90) summed scores=greater communication about cancer within the family. The measure will be assessed as part of the intervention | 3 Month Follow Up |
| 1 day prior to intervention |
| 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. | 1 day prior to intervention |
| 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) | 1 day prior to intervention |
| Income (covariate of the primary outcome) | Categorical assessment of income. Descriptive responses are (1=Less than $20,000; 2=$20,000-$39,999; 3=$40,000-$59,999; 4=$60,000-$79,999; 5=$80,000 or more) | 1 day prior to intervention |
| Employment (covariate of the primary outcome) | Categorical assessment of employment. 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) | 1 day prior to intervention |
| Health literacy (covariate of the primary outcome) | This 3-item measures health literacy: confidence in reading health-related literature (1=extremely confident to 5=not at all confident; higher scores=lower health literacy), having access to a computer (yes or no), and difficulty using a computer to access health-related information (yes or no), where no=health literacy issues. | 1 day prior to intervention |
| Cancer characteristics (covariate of the primary outcome) | Categorical assessment of SEER summary stage at diagnosis. Responses are (1=localized, 2=regional, 3=distant); higher scores=more advanced cancer Categorical assessment of cancer site. Responses are (1=female breast, 0=male prostate) | 1 day prior to intervention |
| Comorbities (covariate of the primary outcome) | Categorical assessment of comorbities.
Responses are 1=yes and 2=no: Comorbidity Count - Count of Heart Problems (MI, CHF, CAD, and AFIB), COPD/Emph, Stroke, High Blood Pressure, High Cholesterol, Hepatitis, Arthritis, Diabetes, Fracture (over 50), Thyroid, Dpression, and Obesity | 1 day prior to intervention |
| BMI (covariate of the primary outcome) | BMI category derived from height and weight 0 = Underweight;
| 1 day prior to intervention |
| Family cancer history (covariate of the primary outcome) | Count of number of blood relatives with cancers that meet NCCN guidelines for increased genetic risk | 1 day prior to intervention |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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