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| ID | Type | Description | Link |
|---|---|---|---|
| UM1CA121947 | U.S. NIH Grant/Contract | View source | |
| U54CA137788 | U.S. NIH Grant/Contract | View source | |
| NCI-2018-01740 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| AMC-A04 | Other Identifier | AIDS Malignancy Consortium | |
| AMC-A04 | Other Identifier | CTEP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Memorial Sloan Kettering Cancer Center | OTHER |
| The Emmes Company, LLC | INDUSTRY |
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This trial develops a health-related symptom index for participants with and either treated or monitored for anal high-grade squamous intraepithelial lesions. The health-related quality of life index may help to capture the symptoms and related experiences of living with or being treated for high-grade squamous intraepithelial lesions.
PRIMARY OBJECTIVES:
I. To develop a Spanish-language version of the anal cancer/high-grade squamous intraepithelial lesions outcomes research (ANCHOR) high-grade squamous intraepithelial lesions (HSIL) health-related quality of life (HRQoL) index (HQI) using state-of-the-art measure development methodology that captures the most important HRQoL symptoms and concerns of those persons diagnosed with anal HSIL and either treated or untreated for anal HSIL.
OUTLINE:
Participants take part in cognitive interviews in Spanish over 45-60 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Services Research (cognitive interviews) | Participants take part in cognitive interviews in Spanish over 45-60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Other | Participate in cognitive interview |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Development of Spanish-language Version of the Anal Cancer/High-grade Squamous Intraepithelial Lesions (HSIL) Outcomes Research (ANCHOR) Health-related Quality of Life (HRQoL) Index-Round 1 and Round 2 | Participants completed A-HRSI, as aurally administered over telephone to indicate whether there were any items or aspects of the instructions that were difficult to understand, and then complete a process of retrospective probing. Summary reports from the Round 1 interview were coded to highlight any instances where a participant indicated that they experienced difficulty with an item or concept within an item. For any item that was reported by at least three participants as difficult for any reason, that item or concept was reviewed to determine whether the difficulty was due to (1) the concept being measured or (2) a translation issue (i.e., register, jargon, or regionalism). These items were revised during a research team panel discussion and used in Round 2 interviews with additional eligible participants. A similar process was used for Round 2. | 45-60 minutes during the telephone call in each round. |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-infected adult men and women with biopsy-proven anal HSIL that was treated in the last 9 months, and who are fluent in Spanish with limited English proficiency.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Atkinson | AIDS Malignancy Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - San Francisco | San Francisco | California | 94143 | United States | ||
| Jackson Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spanish-speaking ANCHOR Participants | Participants were eligible if they were Spanish-speaking with limited English proficiency and had been diagnosed with anal high-grade squamous intraepithelial lesions in the prior nine months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2022 | Oct 26, 2023 |
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| Quality-of-Life Assessment |
| Other |
Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Miami |
| Florida |
| 33136 |
| United States |
| Anal Dysplasia Clinic MidWest | Chicago | Illinois | 60614 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Round 1 |
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| Round 2 |
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| COMPLETED |
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| NOT COMPLETED |
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Spanish Speaking ANCHOR Participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Spanish-speaking ANCHOR Participants | Participants were eligible if they were ... |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Development of Spanish-language Version of the Anal Cancer/High-grade Squamous Intraepithelial Lesions (HSIL) Outcomes Research (ANCHOR) Health-related Quality of Life (HRQoL) Index-Round 1 and Round 2 | Participants completed A-HRSI, as aurally administered over telephone to indicate whether there were any items or aspects of the instructions that were difficult to understand, and then complete a process of retrospective probing. Summary reports from the Round 1 interview were coded to highlight any instances where a participant indicated that they experienced difficulty with an item or concept within an item. For any item that was reported by at least three participants as difficult for any reason, that item or concept was reviewed to determine whether the difficulty was due to (1) the concept being measured or (2) a translation issue (i.e., register, jargon, or regionalism). These items were revised during a research team panel discussion and used in Round 2 interviews with additional eligible participants. A similar process was used for Round 2. | Round 1 included 10 participants and Round 2 had 7 respondents. The Number Analyzed in the Rows differs based on the round of the interview during which the response was recorded. | Posted | Number | participants | 45-60 minutes during the telephone call in each round. |
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All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spanish-speaking ANCHOR Participants | Participants were eligible if they were Spanish-speaking with limited English proficiency and had been diagnosed with anal high-grade squamous intraepithelial lesions in the prior nine months. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas M. Atkinson | Memorial Sloan Kettering Cancer Center | 646-888-0089 | atkinsot@mskcc.org |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Transgender Female |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| R1 difficulty understanding the noun "defecación" (defecate/defecating) |
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| R1 "debres personales" is unclear and does not relate to the daily care activities used as example |
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| R2 "Movilzarse" is not specific enough to the act of physical movement (e.g., walking) |
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| R2 Term "tareas" is confusing |
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| R2 the example "hacer la colada" was characterized as "too regional" or "unfamiliar" |
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| R2 term "ocio" was viewed by three participants as an "archaic" phrase for "leisure" |
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