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Development of a Health-Related Symptom Index for Participants With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions

Development of a Health-Related Symptom Index for Spanish-Speaking Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04276935
Enrollment
20
Registered
2020-02-19
Start date
2018-11-06
Completion date
2020-03-01
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Grade Anal Canal Squamous Intraepithelial Neoplasia, Human Immunodeficiency Virus

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

OTHERInterview

Participate in cognitive interview

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
CollaboratorOTHER
The Emmes Company, LLC
CollaboratorINDUSTRY
AIDS Malignancy Consortium
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
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 245-60 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

ArmCount
Spanish-speaking ANCHOR Participants
Participants were eligible if they were ...
17
Total17

Baseline characteristics

CharacteristicSpanish-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, Continuous52 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 typeEG000
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

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.

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.

ArmMeasureGroupValue (NUMBER)
Spanish Speaking ANCHOR ParticipantsDevelopment 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 2R1 Difficulty with quite a bit (bastante and very much (mucho)4 participants
Spanish Speaking ANCHOR ParticipantsDevelopment 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 2R2 difficulty with not at all (para nada) and not applicable3 participants
Spanish Speaking ANCHOR ParticipantsDevelopment 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 2R1 difficulty understanding the noun defecación (defecate/defecating)3 participants
Spanish Speaking ANCHOR ParticipantsDevelopment 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 2R1 debres personales is unclear and does not relate to the daily care activities used as example3 participants
Spanish Speaking ANCHOR ParticipantsDevelopment 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 2R2 Movilzarse is not specific enough to the act of physical movement (e.g., walking)3 participants
Spanish Speaking ANCHOR ParticipantsDevelopment 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 2R2 the example hacer la colada was characterized as too regional or unfamiliar3 participants
Spanish Speaking ANCHOR ParticipantsDevelopment 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 2R2 term ocio was viewed by three participants as an archaic phrase for leisure3 participants
Spanish Speaking ANCHOR ParticipantsDevelopment 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 2R2 Term tareas is confusing3 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026