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Comparison of Efficacy of Differing Partner-Assisted Skin Examination Interventions for Melanoma Patients: A Randomized Clinical Trial.

ABSTRACT: Early detection of melanoma may improve survival. The present study continued research establishing that in-person training on skin self-examinations (SSEs) was significantly enhanced when delivered to patients with their partners present instead of to patients alone.To examine 3 alternative SSE training approaches that included partners compared with a treatment-as-usual control condition.A randomized clinical trial with 4- and 12-month follow-up visits was conducted at the clinical offices in the ambulatory care area of a hospital. The evaluable population included 494 patients with stage 0 to IIB melanoma and their skin check partners drawn from an electronic medical record melanoma registry and advertisements in large regional newspapers. The study was conducted from June 6, 2011, to April 14, 2014, and analysis was performed between December 4 and December 11, 2014.Pairs of patients and their partners were randomly assigned to (1) in-person intervention, (2) take-home booklet intervention, and (3) treatment-as-usual controls. An additional subgroup of patients received an electronic interactive tablet personal computer intervention. The MoleScore content was comparable across formats and consisted of demonstrations of the ABCDE (assess border, color, diameter, and evolution of pigmented lesions) rule and skills training.Outcomes were self-reported SSE of the total body as well as easy-to-see and difficult-to-see regions at baseline, 4 months, and 12 months.No significant differences in SSEs were observed between the 3 intervention conditions on all of the body areas; results for all 3 intervention conditions were significantly higher than for controls at 4- and 12-month follow-ups (all P

SUBMITTER: Turrisi R

PROVIDER: S-EPMC4565771 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Comparison of Efficacy of Differing Partner-Assisted Skin Examination Interventions for Melanoma Patients: A Randomized Clinical Trial.

Turrisi Rob R Hultgren Brittney B Mallett Kimberly A KA Martini Mary M Robinson June K JK

JAMA dermatology 20150901 9

<h4>Importance</h4>Early detection of melanoma may improve survival. The present study continued research establishing that in-person training on skin self-examinations (SSEs) was significantly enhanced when delivered to patients with their partners present instead of to patients alone.<h4>Objective</h4>To examine 3 alternative SSE training approaches that included partners compared with a treatment-as-usual control condition.<h4>Design, setting, and participants</h4>A randomized clinical trial ...[more]

PMID: 26049533

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Project description:Melanoma has a high survival rate if it is detected early. Training patients with early-stage melanoma who are at risk of developing new melanomas to perform skin self-examination (SSE) may improve survival.To examine for whom the intervention works best in a sample composed of dyads of patients with melanoma and skin-check partners who received an SSE intervention vs customary care.For 494 patients with stage 0 to IIB melanoma (mean age, 55 years; 253 [51.2%] females) and their skin-check partners (mean age, 55 years; 280 [56.7%] females), a randomized clinical trial was conducted in ambulatory care dermatologic offices from June 6, 2011, to April 14, 2014. Follow-up assessments were performed at 12 months. Analysis was performed between March 23 and June 25, 2015.Dyads of 494 patients and their partners were randomly assigned to receive the intervention (395 patients) or customary care (control) (99 patients). The main outcome was patient SSE self-efficacy. Partner motivation to assist with SSE and relationship quality (eg, agreeability, activities with partner, and happiness) were assessed for moderation of the influence of the intervention's effect on SSE self-efficacy.Relationship quality, defined by activities with the partner (? =?-0.892, SE = 0.432, t =?-2.066; P =?.001) and happiness (? =?-4.586, SE = 2.044, t =?-2.24; P =?.001), significantly moderated the intervention effects on patients' SSE self-efficacy. In contrast, patient-partner agreeability (? =?-0.262, SE = 0.148, t =?-1.773; P =?.09) and partner motivation (? =?-0.328, SE = 1.024, t =?-0.320; P =?.10) did not significantly moderate the intervention effects on patients' SSE self-efficacy. Differences between the conditions were highest when activities performed with the partner were below average (mean difference, 6.652; P =?.001) and when happiness was below average (mean difference, 7.000; P =?.001). Although everyone receiving the intervention experienced some benefit, the findings indicate the greatest increases in self-efficacy were observed for those with below-average activities performed with the partner and happiness.The training of patients with melanoma and their partners in early-detection SSE benefited some more than others. Pairs who have low relationship quality, as determined by activities performed with the partner and happiness, may have received the greatest benefits from the training intervention because they were given an activity to perform together.clinicaltrials.gov Identifier: NCT01432860.

Project description:Early detection of melanoma improves survival. Since many melanoma patients and their spouses seek the care of a physician after discovering their melanoma, an ongoing study will determine the efficacy of teaching at-risk melanoma patients and their skin check partner how to conduct skin self-examinations (SSEs). Internet-based health behavior interventions have proven efficacious in creating behavior change in patients to better prevent, detect, or cope with their health issues. The efficacy of electronic interactive SSE educational intervention provided on a tablet device has not previously been determined.The electronic interactive educational intervention was created to develop a scalable, effective intervention to enhance performance and accuracy of SSE among those at-risk to develop melanoma. The intervention in the office was conducted using one of the following three methods: (1) in-person through a facilitator, (2) with a paper workbook, or (3) with a tablet device used in the clinical office. Differences related to method of delivery were elucidated by having the melanoma patient and their skin check partner provide a self-report of their confidence in performing SSE and take a knowledge-based test immediately after receiving the intervention.The three interventions used 9 of the 26 behavioral change techniques defined by Abraham and Michie to promote planning of monthly SSE, encourage performing SSE, and reinforce self-efficacy by praising correct responses to knowledge-based decision making and offering helpful suggestions to improve performance. In creating the electronic interactive SSE educational intervention, the educational content was taken directly from both the scripted in-person presentation delivered with Microsoft PowerPoint by a trained facilitator and the paper workbook training arms of the study. Enrollment totaled 500 pairs (melanoma patient and their SSE partner) with randomization of 165 pairs to the in-person, 165 pairs to the workbook, and 70 pairs to electronic interactive SSE educational intervention.The demographic survey data showed no significant mean differences between groups in age, education, or income. The tablet usability survey given to the first 30 tablet pairs found that, overall, participants found the electronic interactive intervention easy to use and that the video of the doctor-patient-partner dialogue accompanying the dermatologist's examination was particularly helpful in understanding what they were asked to do for the study. The interactive group proved to be just as good as the workbook group in self-confidence of scoring moles, and just as good as both the workbook and the in-person intervention groups in self-confidence of monitoring their moles. While the in-person intervention performed significantly better on a skill-based quiz, the electronic interactive group performed significantly better than the workbook group. The electronic interactive and in-person interventions were more efficient (30 minutes), while the workbook took longer (45 minutes).This study suggests that an electronic interactive intervention can deliver skills training comparable to other training methods, and the experience can be accommodated during the customary outpatient office visit with the physician. Further testing of the electronic interactive intervention's role in the anxiety of the pair and pair-discovered melanomas upon self-screening will elucidate the impact of these tools on outcomes in at-risk patient populations.ClinicalTrials.gov NCT01013844; http://clinicaltrials.gov/show/NCT01013844 (Archived by WebCite at http://www.webcitation.org/6LvGGSTKK).

Project description:INTRODUCTION:We have previously demonstrated that assisted partner services (aPS) increases HIV testing and case finding among partners of persons living with HIV (PLHIV) in a cluster randomized trial in Kenya. However, the efficacy of aPS may vary across populations. In this analysis, we explore differences in aPS efficacy by characteristics of index participants. METHODS:Eighteen HIV testing sites were randomized to immediate versus 6-week delayed aPS. Participants were PLHIV (or index participants) and their sexual partners. Partners of index participants were contacted for HIV testing and linked to care if HIV positive. Primary outcomes were the number of partners per index participant who: 1) tested for HIV, 2) tested HIV positive and 3) enrolled in HIV care. We used generalized estimating equations to assess differences in aPS efficacy by region, testing location, gender, age and knowledge of HIV status. RESULTS:From 2013 to 2015, the study enrolled 1119 index participants, 625 of whom were in the immediate group. These index participants named 1286 sexual partners. Immediate aPS was more efficacious than delayed aPS in promoting HIV testing among partners in high compared to low HIV prevalence regions (Nyanza incidence rate ratio (IRR) 7.2; 95% confidence interval (CI) 5.4, 9.6 vs. Nairobi/Central IRR 3.4 95% CI 2.3, 4.8). Higher rates of partner HIV testing were also observed for index participants in rural/peri-urban compared to urban sites (IRR 6.6; 95% CI 4.5, 9.6 vs. IRR 3.5 95% CI 2.5, 5.0 respectively), for female versus male index participants (IRR 5.8 95% CI 4.2, 7.9 vs. IRR 3.7; 95% CI 2.4, 5.8 respectively) and for newly diagnosed versus known HIV-positive index participants (IRR 6.0 95% CI 4.2, 8.7 vs. IRR 3.3; 95% CI 2.0, 7.7 respectively). Providing aPS to female versus male index participants also had a significantly higher HIV case finding rate (IRR 9.1; 95% CI 4.0, 20.9 vs. IRR 3.2 95% CI 1.7, 6.0 respectively.) CONCLUSIONS: While it is known that aPS promotes increases in HIV testing and case finding, this is the first study to demonstrate significant differences in aPS efficacy across characteristics of the index participant. Understanding these differences and their drivers will be critical as aPS is brought to scale in order to ensure all PLHIV have access to these services.

Project description:ImportanceSkin self-examination (SSE) is a key factor in the early detection of melanoma, and many new and recurrent melanomas are first detected by patients themselves or their family members.ObjectiveTo explore the views of patients with melanoma regarding SSE in general, as well as their attitudes toward using novel digital technologies to support their own SSE.Design, setting, and participantsQualitative study with semistructured interviews that were conducted from June 20 to December 12, 2016, with 37 individuals in Sydney, Australia, who were previously treated for a first primary localized melanoma during 2014 and had not had a recurrence or new primary melanoma in the time since treatment.Main outcomes and measuresPatients' views and experiences, analyzed thematically.ResultsA total of 37 patients (11 women and 26 men; median age, 67 years [interquartile range, 59.5-72 years]) were interviewed. Participants perceived SSE as important for the early identification of local recurrence or new primary melanomas. Despite this belief, participants did not report undertaking full-body SSE on a regular basis. Factors that influenced their low engagement in thorough SSE included lack of self-efficacy, reliance on clinician consultations as the primary means of melanoma detection, and fear of cancer recurrence. Regarding the use of digital technology to assist with SSE, the key motivating factors in favor of such tools were the ability to track changes in lesions over time and the use of automated reminders to undertake SSE. Deterrents included a lack of confidence in undertaking SSE and in using new technology.Conclusions and relevancePatients with melanoma are aware of the importance of thorough skin examinations. However, a lack of confidence in their ability to undertake SSE and reliance on clinicians as the primary means of melanoma detection may inhibit patients from undertaking regular and thorough SSE. Patients may benefit from new digital technologies that assist them in undertaking SSE, provided they have appropriate education and technical support.

Project description:Pedometer-based programs have elicited increased walking behaviors associated with improvements in blood pressure in sedentary/low active postmenopausal women, a population at increased risk of cardiovascular disease. Such programs typically encourage increasing the volume of physical activity with little regard for its intensity. Recent advances in commercially available pedometer technology now permit tracking of both steps/day and time in moderate (or greater) intensity physical activity on a daily basis. It is not known whether the dual message to increase steps/day while also increasing time spent at higher intensity walking will elicit additional improvements in blood pressure relative to a message to only focus on increasing steps/day. The purpose of this paper is to present the rationale, study design, and protocols employed in WalkMore, a 3-arm 3-month blinded and randomized controlled trial (RCT) designed to compare the effects of two community pedometer-based walking interventions (reflecting these separate and combined messages) relative to a control group on blood pressure in sedentary/low active post-menopausal women, a population at increased risk of cardiovascular disease.120 sedentary/low active post-menopausal women (45-74 years of age) will be randomly assigned (computer-generated) to 1 of 3 groups: A) 10,000 steps/day (with no guidance on walking intensity/speed/cadence; BASIC intervention, n?=?50); B) 10,000 steps/day and at least 30 minutes in moderate intensity (i.e., a cadence of at least 100 steps/min; ENHANCED intervention, n?=?50); or a Control group (n?=?20). An important strength of the study is the strict control and quantification of the pedometer-based physical activity interventions. The primary outcome is systolic blood pressure. Secondary outcomes include diastolic blood pressure, anthropometric measurements, fasting blood glucose and insulin, flow mediated dilation, gait speed, and accelerometer-determined physical activity and sedentary behavior.This study can make important contributions to our understanding of the relative benefits that walking volume and/or intensity may have on blood pressure in a population at risk of cardiovascular disease.ClinicalTrials.gov Record NCT01519583, January 18, 2012.

Project description:ImportanceMore than 1 million patients with melanoma in the United States are at risk to develop a second primary melanoma. Early detection of melanoma improves survival. Patients with melanoma may be able to self-manage care with their skin-check partners ("partners") and alert the physician when a concerning lesion is identified, thus providing an important adjunct to yearly skin examinations by a physician.ObjectiveTo evaluate the effect of a structured skin self-examination (SSE) intervention for patients with melanoma and their partners ("dyads") on SSE performance and the detection of new melanomas by the dyad or the physician.Design, setting, and participantsRandomized clinical trial with 24-month follow-up assessments. Patients with stage 0 to IIB melanoma and their skin-check partners participated from June 6, 2011, to April 24, 2015.InterventionsDyads of patients and their partners were randomly assigned to receive the skills training intervention or customary care (control group).Main outcomes and measuresThe main outcome was frequency of SSE performance. The secondary outcome was detection of a new or recurrent melanoma by the dyad or physician. The tertiary outcome was the number of unscheduled physician appointments for concerning lesions.ResultsThe study cohort comprised 494 participants. The patient population was 51.2% (253 of 494) female and had a mean (SD) age of 55 (10) years. Patients in the intervention arms had significantly increased SSEs with their partners at 4, 12, and 24 months (P < .001 for all) compared with the control group (mean differences, 1.57 [95% CI, 1.29-1.85], 0.72 [95% CI, 0.39-1.06], and 0.94 [95% CI, 0.58-1.30], respectively). Patients in the intervention arms identified new melanomas more than those in the control group (χ21 = 28.77, P < .01 [n = 51 melanomas in situ] and χ21 = 6.43, P < .05 [n = 18 invasive melanomas]) and did not increase physician visits.Conclusions and relevancePatients with melanoma and their partners reliably performed SSE after participating in a structured skills training program lasting approximately 30 minutes, with reinforcement every 4 months by the study dermatologist. Accurate SSE by those at risk to develop melanoma may enhance early detection and relieve some of the burden on health services to provide continuing follow-up to a growing population of eligible patients.Trial registrationclinicaltrials.gov Identifier: NCT01432860.

Dataset Information

Comparison of Efficacy of Differing Partner-Assisted Skin Examination Interventions for Melanoma Patients: A Randomized Clinical Trial.

Publications

Comparison of Efficacy of Differing Partner-Assisted Skin Examination Interventions for Melanoma Patients: A Randomized Clinical Trial.

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