Neoplasms

All Conditions

Immune System Diseases

Behaviors and Mental Disorders

Head and Neck Neoplasms

Hypersensitivity

Quality of Life

Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer

3x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck

Dermatoscope

Blood sample is examined for breaks per metaphase to determine radiation sensibility of the individual

3-Colour FISH

Elisabeth Silberberger, MSc

Hans Geinitz, Prim. Univ.-Prof. Dr.

Elisabeth Silberberger, MSC

The purpose of this study is to determine whether any eventual skin damage caused by radiation therapy can be detected and monitored at a subclinical level via optical coherence tomography (OCT). Another key question is whether subclinical OCT detected skin damage correlates with acute and late clinical toxicity.

Head and neck cancer patients that meet the eligibility criteria and singned the informed consent will undergo OCT-measurements before, during and after the course of radiation therapy. At the same time-points the skin areas are evaluated with dermatoscopy and patients are asked to self-assess their quality of life (EORTC QLQ C30 and respective head and neck module H\&N 43). Before the onset of radiation therapy radiation sensitivity analysis will be performed with in-vitro irradion of peripheral blood lymphocytes (FISH).

Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer

Live Laser Microscopic Evaluation (OCT) of Radiation Induced Preclinical Alterations of the Skin in Head and Neck Cancer Patients

any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)

Correlation of OCT changes with CTC radiation toxicity

Correlation of OCT with chromosome-breaks per metaphasis in in-vitro irradiated blood lymphocytes (FISH)

Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy

Correlation of quality of live as measured with the EORT QLC C30 and Head and neck module H\&N 43 with OCT and radiation sensitivity

Verein zur Forschungsförderung der Krebshilfe OÖ

RECENDT GmbH

Johannes Kepler Universität Linz, Abteilung FLLL

Universitätsklinikum Erlangen

Andreas Fahl Medizintechnik-Vertrieb GmbH

Krankenhaus Barmherzige Schwestern Linz

Prim. Univ.-Prof. Dr.

Skin and Connective Tissue Diseases

Carcinoma

Skin Neoplasms

Skin Diseases

Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months.

Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit.

Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit. Physicians also receive a free dermatoscope with instructions for uploading images of suspect lesions and attend a 30-minute online course comprising additional descriptions of dermoscopic images for skin cancers and "mimickers" common in hematopoietic stem cell transplantation patients, along with clear instructions for using a dermatoscope and steps to integrate dermoscopy into their practice.

Computer-Assisted Intervention

Educational Intervention

Receive physician directed letter and educational package

Educational Intervention (Physician)

Questionnaire Administration

Text Message

Saro H Armenian

This trial studies the impact of a 12-month invention focused on early detection of skin cancer and timely follow up in patients who underwent stem cell transplant and their primary care providers. Some stem cell transplant survivors may develop complications related to the treatment they received. Many of these complications may not be known for years after the treatment and preventive measures can be taken to reduce the chances that a complication will occur and encourage early detection. This study focuses on one complication that stem cell transplant survivors are at high risk of developing - skin cancer. An early diagnosis of skin cancer is important since the cancer is usually smaller, requires less extensive treatments, and has better outcomes. Teaching skin self-examination and encouraging patients to alert doctors to skin changes may provide an important opportunity for early detection of skin cancer.

PRIMARY OBJECTIVES:

I. Determine the impact of patient activation and education (PAE, N=360) alone or with physician activation (PAE+Phys, N=360) on skin cancer screening and health promotion practices at 12 months, measured by percentage of survivors who conduct skin self-exam and receive physician skin exam, and time to detection and diagnosis of suspicious lesions.

II. Among primary care physicians of transplant patients, determine the impact of an e-learning teledermoscopy program compared with provision of print materials for identifying suspect lesions.

OUTLINE: Participants are randomized to 1 of 3 groups.

GROUP I: Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months.

GROUP II: Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit.

GROUP III: Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit. Physicians also receive a free dermatoscope with instructions for uploading images of suspect lesions and attend a 30-minute online course comprising additional descriptions of dermoscopic images for skin cancers and "mimickers" common in hematopoietic stem cell transplantation patients, along with clear instructions for using a dermatoscope and steps to integrate dermoscopy into their practice.

Technology-Enabled Activation of Skin Cancer Screening for Stem Cell Transplant Survivors and Their Primary Care Providers, TEACH Study

Technology-Enabled Activation of Skin Cancer Screening for Hematopoietic Cell Transplantation Survivors and Their Primary Care Providers (TEACH)

Will administer questionnaires at baseline and 12 months to ask about skin examinations performed within the past 12 months. Will use logistic regression to adjust for imbalance in patient characteristics and risk factors. Will also test for group by covariate interactions, depending on group main effect.

Will be a continuous variable, and will employ a generalized linear model to compare the interval between the two study arms, adjusted for covariates of interest. Will begin with bivariate models to determine potential variables to include in a multivariable regression model. If the group main effect is significant, interactions of the group main effect with other variables will be examined.

Will compare the group difference in changes in attitude over time, using generalized estimating equation (GEE) for normally distributed data, with a compound symmetry covariance matrix analysis to account for within-physician correlation. Will dichotomize the Likert scale (1-5) response and compare the proportion of primary care physicians (PCPs) reporting a higher (\>= 4 versus \< 4) level of confidence at 12 months (m) compared to baseline between groups, using the longitudinal binomial GEE model with a compound symmetry covariance structure. Covariate adjustment will be made in these models as necessary.

Evaluated using standard incremental cost-effectiveness analysis methods will be used to assess the impact of assumptions and uncertainty on results and conclusions.

Evaluated using standard incremental sensitivity analysis will be used to assess the impact of assumptions and uncertainty on results and conclusions.

Will estimate the cost per additional self skin exam completed and the cost per additional PCP exam completed, comparing the two intervention arms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer	NCT04610645	Head and Neck C... Radiotherapy	OCT Dermatoscope 3-Colour FISH	18 Years - 99 Years	Krankenhaus Barmherzige Schwestern Linz
Technology-Enabled Activation of Skin Cancer Screening for Stem Cell Transplant Survivors and Their Primary Care Providers, TEACH Study	NCT04358276	Skin Carcinoma	Computer-Assist... Dermatoscope Educational Int... Educational Int... Questionnaire A... Text Message	18 Years -	City of Hope Medical Center

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