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Quality of Life

Participants complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also undergo a cognitive interview for up to 3 sessions.

Complete cognitive interview to elicit relevant HSIL symptoms, compare to study index of symptoms, and rank symptoms in relation to effect on health-related quality of life

Concept Elicitation

Comprehension assessment of draft quality of life assessment

Comprehension Assessment

Jack Burkhalter

This research trial studies health-related symptom questionnaires in measuring quality of life in human immunodeficiency virus (HIV)-infected participants treated with or monitored for anal lesions. Collecting information and symptoms from patients diagnosed with anal lesions may help reduce the risk of anal cancer.

PRIMARY OBJECTIVES:

I. To develop an Anal Cancer/HSIL Outcomes Research Study (ANCHOR) high-grade squamous intraepithelial lesion (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 complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also complete a cognitive interview for up to 3 sessions.

Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions

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

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Northwestern University

The Emmes Company, LLC

University of Arkansas

AIDS Malignancy Consortium

Slow Virus Diseases

Participants take part in cognitive interviews in Spanish over 45-60 minutes.

Interview

Quality-of-Life Assessment

Questionnaire Administration

Thomas Atkinson

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.

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)

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.

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.

Spanish-speaking ANCHOR Participants

Participants were eligible if they were ...

Age, Categorical

Age, Continuous

Gender Identification

Sex/Gender, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Thomas M. Atkinson

R1 Difficulty with "quite a bit (bastante" and "very much" (mucho)"

R2 difficulty with "not at all (para nada)" and "not applicable"

R1 difficulty understanding the noun "defecación" (defecate/defecating)

R1 "debres personales" is unclear and does not relate to the daily care activities used as example

R2 "Movilzarse" is not specific enough to the act of physical movement (e.g., walking)

R2 Term "tareas" is confusing

R2 the example "hacer la colada" was characterized as "too regional" or "unfamiliar"

R2 term "ocio" was viewed by three participants as an "archaic" phrase for "leisure"

Participants take part in cognitive interviews in Spanish over 45-60 minutes.

Interview: Participate in cognitive interview

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Spanish Speaking ANCHOR Participants

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.

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

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions	NCT02418494	High Grade Anal... HIV Infection	Concept Elicita... Comprehension A...	35 Years -	AIDS Malignancy Consortium
Development of a Health-Related Symptom Index for Participants With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions	NCT04276935	High Grade Anal... Human Immunodef...	Interview Quality-of-Life... Questionnaire A...	18 Years -	AIDS Malignancy Consortium

Spots Global Cancer Trial Database for high grade anal canal squamous intraepithelial neoplasia