Construct validity and responsiveness of a health-related symptom index for persons either treated or monitored for anal high-grade squamous intraepithelial lesions (HSIL): AMC-A01/-A03.

PURPOSE: To determine whether treatment of anal high-grade squamous intraepithelial lesions (HSIL), vs active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV, the US National Cancer Institute funded the Phase III ANal Cancer/HSIL Outcomes Research (ANCHOR) clinical trial. As no established patient-reported outcomes (PRO) tool exists for persons with anal HSIL, we sought to estimate the construct validity and responsiveness of the ANCHOR Health-Related Symptom Index (A-HRSI). METHODS: The construct validity phase enrolled ANCHOR participants who were within two weeks of randomization to complete A-HRSI and legacy PRO questionnaires at a single time point. The responsiveness phase enrolled a separate cohort of ANCHOR participants who were not yet randomized to complete A-HRSI at three time points: prior to randomization (T1), 14-70 (T2), and 71-112 (T3) days following randomization. RESULTS: Confirmatory factor analysis techniques established a three-factor model (i.e., physical symptoms, impact on physical functioning, impact on psychological functioning), with moderate evidence of convergent validity and strong evidence of discriminant validity in the construct validity phase (n = 303). We observed a significant moderate effect for changes in A-HRSI impact on physical functioning (standardized response mean = 0.52) and psychological symptoms (standardized response mean = 0.60) from T2 (n = 86) to T3 (n = 92), providing evidence of responsiveness. CONCLUSION: A-HRSI is a brief PRO index that captures health-related symptoms and impacts related to anal HSIL. This instrument may have broad applicability in other contexts assessing individuals with anal HSIL, which may ultimately help improve clinical care and assist providers and patients with medical decision-making.

Linguistic validation of the Spanish version of the Anal Cancer High-Grade squamous intraepithelial lesions outcomes Research Health-Related Symptom Index (A-HRSI): AMC-A04.

OBJECTIVES: The Anal Cancer High-grade squamous intraepithelial lesions (HSIL) Outcomes Research (ANCHOR) Health-Related Symptom Index (A-HRSI) is a 25-item measure that assesses physical symptoms and impacts, and psychological symptoms. To promote generalizability and equity in the capture of these concepts in Spanish-speaking participants, we linguistically validated a Spanish version of A-HRSI. METHODS: Following independent forward translation and reconciliation of A-HRSI from English to Spanish, two rounds of cognitive interviews were completed with ANCHOR participants who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish. Interviews were coded to highlight any items and concepts that were reported as being difficult for any reason by ≥ 3 participants, with such items revised during a research team panel discussion and tested in a second round of interviews if applicable. RESULTS: Seventeen participants representing 8 nationalities were enrolled (Round 1 n=10, Round 2 n=7); 7 participants reported not completing high school (41.2%). No difficulties were reported with respect to the theoretical concepts measured by A-HRSI. We made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). CONCLUSION: The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL. Language is a tremendous barrier to enrolling patients to clinical trials. The anal cancer high-grade squamous intraepithelial lesions (HSIL) outcomes research [ANCHOR] trial is a randomized clinical trial that recently established that the treatment of anal HSIL, versus active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV (PLWH). The ANCHOR Health-Related Symptom Index (A-HRSI) is a 25-item patient-reported outcomes measure that was developed to assess physical symptoms, physical impacts, and psychological symptoms related to anal HSIL. As approximately 10% of ANCHOR participants preferred the delivery of their healthcare in Spanish, the purpose of the present study was to linguistically validate a Spanish version of A-HRSI. Based on feedback from interviews with 17 participants from the ANCHOR trial who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish, we made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL as part of clinical trials or routine care.

Feasibility and acceptability of using an IVRS to assess decision making about sun protection.

OBJECTIVE: We developed an interactive voice response system (IVRS), an automated telephone survey technology, to assess real-time decision making about sun protection. We examined the feasibility and acceptability of IVRS in this electronic health (eHealth) context. METHODS: Melanoma patients who underwent surgery referred their first-degree relatives (FDRs) for participation. Eligible FDRs were contacted twice daily (12:30 pm; 5:00 pm) over 14 consecutive days via IVRS to complete a survey about their sun protection behaviors and decisions about those behaviors. RESULTS: Of the 81 eligible FDRs, 69 (85%) consented to the study, and 53 (77%) completed the study. We assessed adherence with the IVRS via the number and pattern of missing survey items across all answered IVRS calls. About 80% of scheduled IVRS calls were answered (1316/1652). Most surveys (93%) of the IVRS-answered calls were completed. To examine acceptability, we analyzed the program satisfaction survey data collected at the end of the study. Most participants viewed the IVRS to be highly acceptable and easy to use. CONCLUSIONS: These findings illustrate that use of real-time IVRS data collection regarding sun protection decision making is feasible and acceptable to higher-risk research participants and could thus be used with time and location-sensitive eHealth support to enhance sun protection decision making.

Randomized trial of a presurgical scheduled reduced smoking intervention for patients newly diagnosed with cancer.

OBJECTIVE: Cancer patients who smoke are advised to quit smoking to reduce treatment complications and future cancer risk. This study's main objective was to evaluate the efficacy of a novel, presurgical cessation intervention in newly diagnosed cancer patients scheduled for surgical hospitalization. METHOD: We conducted a parallel-arm, randomized controlled trial comparing the efficacy of our hospital-based, tobacco cessation "best practices" treatment model (BP; cessation counseling and nicotine replacement therapy) with BP enhanced by a behavioral tapering regimen (scheduled reduced smoking; BP + SRS) administered by a handheld computer before hospitalization for surgery. Cessation outcomes were short (hospital admission and 3 months) and longer-term (6 months) biochemically verified smoking abstinence. We hypothesized that BP + SRS would be superior to BP alone. One hundred eighty-five smokers were enrolled. RESULTS: Overall, 7-day-point prevalence, confirmed abstinence rates at 6 months for BP alone (32%) and BP + SRS (32%) were high; however, no main effect of treatment was observed. Patients who were older and diagnosed with lung cancer were more likely to quit smoking. CONCLUSION: Compared to best practices for treating tobacco dependence, a presurgical, scheduled reduced smoking intervention did not improve abstinence rates among newly diagnosed cancer patients.reserved).

Factors associated with inconsistent sun protection in first-degree relatives of melanoma survivors.

First-degree relatives (FDRs) of melanoma survivors are at heightened risk for developing melanoma, but use sun protection inconsistently. To develop appropriate interventions, in this article we identify factors related to sun protection inconsistency in melanoma FDRs using ethnographic decision tree modeling. We conducted in-home interviews with 25 melanoma FDRs balanced across gender and sunbathing attitudes and identified factors related to daily decision making about use of sunscreen, shade seeking, hats, and clothing. Results indicated primary facilitators for sun protection involved water settings and sunny weather. Physical activities such as exercise served to promote as well as inhibit sun protection. If participants anticipated shade cover, they tended to forgo other sun protection. The use of hats and clothing was often dictated by nonsun-protection goals. Understanding factors related to inconsistent sun protection with detail and nuance is an important prerequisite to interventions aimed to improve sun-protection maintenance in this population.