Dataset Information

Randomised controlled trial to evaluate the influence of mHealth and eHealth skin cancer prevention education among young organ transplant recipients: the HIPPOlino intervention study.

ABSTRACT:

Objectives

To determine whether a multicomponent sun protection intervention programme (mHealth) for young organ transplant recipients (OTR) leads to a higher increase of preventive knowledge and behavioural change than an e-learning education programme (eHealth).

Design

Randomised controlled trial with one preintervention baseline survey and three follow-up surveys after 6 weeks, 6 and 12 months. Comparison of two different intervention schedules with a control group (CG).

Setting

Multicomponent sun protection trainings in Germany, the Netherlands and Austria between June 2013 and September 2015.

Participants

137 OTRs (5-22 years of age, 61 females/76 males) participated in the study.

Interventions

(A) Intervention group 1 (IG1): personal training with subsequent forwarding of individual ultraviolet index-dependent sun protection recommendations via short message service (SMS); (B) intervention group 2 (IG2): e-learning training without SMS; (C) CG: regular information letters, online training after 1?year.

Outcome measures

Key questions were used to form a knowledge and a behavioural score. Behavioural strategies and knowledge were quantified through self-administered questionnaires.

Results

Analyses 6?weeks after the intervention showed a higher knowledge increase in both IG compared with the CG (IG1 to CG: OR 12.64, 95%?CI 4.20 to 38.20; IG2 to CG: OR 2.59, 95% CI 0.95 to 7.04). Sun protection behaviour improved slightly but not significantly in both IG (IG1 to CG: OR 2.56, 95% CI 0.93 to 7.00; IG2 to CG: OR 1.22, 95% CI 0.45 to 3.32). One year after the intervention, no behavioural changes were observed in either IG compared with the CG. IG1 but not IG2 still scored significantly higher in sun protection knowledge than the CG 1?year after intervention (IG1 to CG: OR 4.46, 95% CI 1.48 to 13.43; IG2 to CG: OR 1.41, 95% CI 0.51 to 3.93).

Conclusions

This multicomponent sun protection programme provides a promising strategy to increase sun protection knowledge and possibly also protective behaviour in young OTR.

Trial registration number

DRKS00011393.

SUBMITTER: Bottcher S

PROVIDER: S-EPMC6937057 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomised controlled trial to evaluate the influence of mHealth and eHealth skin cancer prevention education among young organ transplant recipients: the HIPPOlino intervention study.

Böttcher Silke S Buck Christoph C Zeeb Hajo H Laschewski Gudrun G Hauer Carolin C Wagner Gunnar G Sachse Michael Max MM

BMJ open 20191216 12

<h4>Objectives</h4>To determine whether a multicomponent sun protection intervention programme (mHealth) for young organ transplant recipients (OTR) leads to a higher increase of preventive knowledge and behavioural change than an e-learning education programme (eHealth).<h4>Design</h4>Randomised controlled trial with one preintervention baseline survey and three follow-up surveys after 6 weeks, 6 and 12 months. Comparison of two different intervention schedules with a control group (CG).<h4>Set ...[more]

PMID: 31848158

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Project description:BackgroundThe risk of cutaneous squamous cell carcinoma (cSCC) is significantly increased in organ transplant recipients (OTRs). Clearance of actinic keratoses (AKs) is generally regarded as a surrogate biomarker for cSCC prevention. OTR-cSCC chemoprevention with topical AK treatments has not been investigated in randomized controlled trials (RCTs), although there is evidence that 5% 5-fluorouracil (5-FU) may be chemoprotective in immunocompetent patients.ObjectivesTo assess the feasibility, activity and evaluation outcomes relevant to the design of a future phase III RCT of topical cSCC chemoprevention in OTRs.MethodsOTRs with 10 or more AKs in predefined areas were randomized 1 : 1 : 1 to topical 5-FU, 5% imiquimod (IMIQ) or sunscreen (sun-protective factor 30+) in a phase II, open-label RCT over 15 months. Feasibility outcomes included proportions of eligible OTRs randomized, completing treatment and willing to be re-treated. AK activity [AK clearance, new AK development, patient-centred outcomes (toxicity, health-related quality of life, HRQoL)] and evaluation methodology (clinical vs. photographic) were assessed.ResultsForty OTRs with 903 AKs were randomized. All feasibility outcomes were met (56% of eligible OTRs were randomized; 89% completed treatment; 81% were willing to be re-treated). AK activity analyses found 5-FU and IMIQ were superior to sunscreen for AK clearance and prevention of new AKs. 5-FU was more effective than IMIQ in AK clearance and prevention in exploratory analyses. Although toxicity was greater with 5-FU, HRQoL outcomes were similar.ConclusionsTrials of topical AK treatments in OTRs for cSCC chemoprevention are feasible and AK activity results support further investigation of 5-FU-based treatments in future phase III trials. What is already known about this topic? Cutaneous squamous cell carcinoma (cSCC) is significantly more common in immunocompromised individuals including organ transplant recipients (OTRs) compared with immunocompetent populations. cSCC chemoprevention activity of sunscreen and 5-fluorouracil-based (5-FU) actinic keratosis (AK) treatments has been demonstrated in randomized controlled trials (RCTs) in immunocompetent populations but not in OTRs. AKs are cSCC precursors and their clearance and prevention are generally regarded as surrogate endpoint biomarkers for potential cSCC chemoprevention activity. What does this study add? SPOT (SCC Prevention in OTRs using Topical treatments) has confirmed that RCTs of OTR-cSCC chemoprevention with topical AK treatments are feasible. It also suggests that topical 5-FU may be superior to 5% imiquimod and sunscreen in AK clearance and prevention. Together with recent evidence from several RCTs in the general population, these data provide a compelling rationale for further studies of intervention with 5-FU-based topical chemoprevention approaches in OTR-cSCC prevention.

Project description:ImportanceNonkeratinocyte skin cancers are an important cause of morbidity and mortality for immunosuppressed solid organ transplant recipients (SOTRs), but the spectrum of disease and risk factor characteristics are unknown.ObjectiveTo characterize the spectrum of disease and risk factors for common and rare nonkeratinocyte skin cancers in SOTRs.Design, setting, and participantsThis population-based cohort study included 444 497 SOTRs who underwent a transplant in the US between January 1, 1987, and December 31, 2017, using linked data from the national transplant registry and 32 cancer registries. Data analysis was conducted from April 1, 2021, to September 30, 2021.Main outcomes and measuresStandardized incidence ratios (SIRs) were used to assess risk relative to the general population, and Poisson regression was used to evaluate risk factors.ResultsA total of 2380 nonkeratinocyte skin cancers were identified among 444 497 SOTRs (median age at transplant, 50 years; range, 0-96 years; 274 276 [61.7%] male; 272 241 [61.2%] non-Hispanic White). Melanoma was the most common cancer (1471 [61.8%]), followed by Merkel cell carcinoma (334 [14.0%]), Kaposi sarcoma (186 [7.8%]), sebaceous carcinoma (170 [7.1%]), and cutaneous lymphomas (108 [4.5%]). Risks were most strongly elevated for cancers associated with viruses, including Kaposi sarcoma (SIR, 20.5; 95% CI, 17.7-23.7), Merkel cell carcinoma (SIR, 16.2; 95% CI, 14.5-18.1), and extranodal natural killer/T-cell lymphoma (SIR, 44.3; 95% CI, 5.37-160). Risks were also significantly elevated for sebaceous carcinoma (SIR, 15.2; 95% CI, 13.0-17.7), anaplastic large cell lymphoma (SIR, 6.82; 95% CI, 4.53-9.85), and diffuse large B-cell lymphoma (SIR, 5.17; 95% CI, 3.28-7.76). Several characteristics were independently associated with greater risk for multiple skin cancer types, including male sex, older age at transplant, factors associated with UV radiation exposure (non-Hispanic White race and ethnicity, living in an area with higher UV radiation exposure, and posttransplant diagnosis of keratinocyte carcinoma), and increasing time since transplantation. Treatment with mammalian target of rapamycin inhibitors was associated with reduced melanoma incidence (incidence rate ratio, 0.75; 95% CI, 0.57-0.98). A total of 847 skin cancers (39.4%) occurred on the head and neck.Conclusions and relevanceThe findings of this cohort study suggest that viruses, UV radiation exposure, and immunosuppression are associated with the development of skin cancer in SOTRs. Certain high-risk subgroups may benefit from increased skin surveillance, and treatment with mammalian target of rapamycin inhibitors could be effective for melanoma chemoprevention in the transplant population.

Dataset Information

Randomised controlled trial to evaluate the influence of mHealth and eHealth skin cancer prevention education among young organ transplant recipients: the HIPPOlino intervention study.

Objectives

Design

Setting

Participants

Interventions

Outcome measures

Results

Conclusions

Trial registration number

Publications

Randomised controlled trial to evaluate the influence of mHealth and eHealth skin cancer prevention education among young organ transplant recipients: the HIPPOlino intervention study.

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