Trial Outcomes & Findings for Development of a Health-Related Symptom Index for Participants With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (NCT NCT04276935)
NCT ID: NCT04276935
Last Updated: 2025-03-07
Results Overview
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.
COMPLETED
20 participants
45-60 minutes during the telephone call in each round.
2025-03-07
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
20
|
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Overall Study
Round 1
|
10
|
|
Overall Study
Round 2
|
7
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of a Health-Related Symptom Index for Participants With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions
Baseline characteristics by cohort
| Measure |
Spanish-speaking ANCHOR Participants
n=17 Participants
Participants were eligible if they were ...
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identification · Cisgender Male
|
12 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identification · Cisgender Female
|
3 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identification · Transgender Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Spanish Speaking ANCHOR Participants
n=17 Participants
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
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|---|---|
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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
|
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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
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3 participants
|
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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)"
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4 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"
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3 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)
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3 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
|
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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"
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3 participants
|
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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"
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3 participants
|
Adverse Events
Spanish-speaking ANCHOR Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Thomas M. Atkinson
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place