High Grade Anal Canal Squamous Intraepithelial Neoplasia, Human Immunodeficiency Virus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Participate in cognitive interview
Ancillary studies
Ancillary studies
Sponsors
Study design
Eligibility
Inclusion criteria
* Human immunodeficiency virus (HIV)-1 infection. * Biopsy-proven anal HSIL within the prior nine months. * Participant must have received anal HSIL treatment in the last nine months. If the participant's treatment plan is observation? the participant must have been diagnosed with anal HSIL in the last nine months. * Life expectancy of greater than 5 years. * Fluent in Spanish with limited English proficiency, per self-report.
Exclusion criteria
* History of anal cancer. * Inability to understand a written consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 45-60 minutes during the telephone call in each round. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spanish-speaking ANCHOR Participants Participants were eligible if they were ... | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Spanish-speaking ANCHOR Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 52 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 12 Participants |
| Sex/Gender, Customized Gender Identification Cisgender Female | 3 Participants |
| Sex/Gender, Customized Gender Identification Cisgender Male | 12 Participants |
| Sex/Gender, Customized Gender Identification Transgender Female | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 45-60 minutes during the telephone call in each round.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spanish Speaking ANCHOR Participants | 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 | R1 Difficulty with quite a bit (bastante and very much (mucho) | 4 participants |
| Spanish Speaking ANCHOR Participants | 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 | R2 difficulty with not at all (para nada) and not applicable | 3 participants |
| Spanish Speaking ANCHOR Participants | 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 | R1 difficulty understanding the noun defecación (defecate/defecating) | 3 participants |
| Spanish Speaking ANCHOR Participants | 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 | R1 debres personales is unclear and does not relate to the daily care activities used as example | 3 participants |
| Spanish Speaking ANCHOR Participants | 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 | R2 Movilzarse is not specific enough to the act of physical movement (e.g., walking) | 3 participants |
| Spanish Speaking ANCHOR Participants | 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 | R2 the example hacer la colada was characterized as too regional or unfamiliar | 3 participants |
| Spanish Speaking ANCHOR Participants | 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 | R2 term ocio was viewed by three participants as an archaic phrase for leisure | 3 participants |
| Spanish Speaking ANCHOR Participants | 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 | R2 Term tareas is confusing | 3 participants |