Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.

Women view an educational poster in changing room, and they receive a brochure.

Minimal Intervention

Intensive Intervention

June K. Robinson, MD

The skin self-examination for melanoma (SSE) educational materials were developed with the input provided by women undergoing screening mammograms. The investigators seek to evaluate the performance of SSE by women and find out if women seek care with a dermatologist for a concerning mole or for a melanoma screening examination by a dermatologist after reviewing the materials received during the mammogram visit. The purpose of this study is to enhance the early detection of melanoma among women who are engaging in health promotion by having mammograms. The investigators specifically aim to evaluate the performance of SSE by women, who receive information during their mammogram appointment, and then follow-up with dermatology for a melanoma screening examination.

The proposed study is the second phase of a project assessing the feasibility and effectiveness of enhancing the early detection of melanomas among women, who are engaging in health promotion by having mammograms. The initial phase of the project framed risk messages, developed posters and brochures with the input provided by women undergoing screening mammograms, and assessed the feasibility of delivering the program during the mammogram visit at the Lynn Sage Comprehensive Breast Center of Northwestern Medicine/ Prentice Women's Hospital. The investigators seek to evaluate performance of skin self-examination (SSE) by women, who receive information during their mammogram appointment, and follow-up with dermatology for a melanoma screening examination. In the second phase, a more intensive intervention in which women will not only receive information about SSE, but will also receive a reminder to perform SSE one week after the screening mammogram and information on how to schedule an appointment with dermatology will be provided. The number of women who perform SSE at home and find a concerning mole (lesion), number who see a dermatologist, and number who have a concerning lesion biopsied will be compared in two arms of the study 1) women who receive the intensive intervention 2) women who receive the informational brochure about SSE alone. The hypothesis is that women who receive more the intensive educational intervention will be more likely to perform SSE at home and schedule a follow-up dermatologist appointment as compared to those who receive the information brochure alone. This project builds upon Robinson's successful SSE training program for melanoma patients that resulted in patients' accurate evaluations of suspicious lesions relative to dermatologists' skin examinations.

Skin Self-Examination Education During Mammography

Effect of Skin Self-examination Education Delivered During the Mammography Experience.

The percentage of participants that performed skin self-examination at the 3-month time interval.

The total number of melanomas identified by a dermatologist in women who found a concerning mole

Sarah M. Friedewald, MD

Jennifer N. Choi, MD

Northwestern University

Research Professor of Dermatology

Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week by telephone call, text message or email to perform SSE.

Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure.

Participants receive brochure, card advising how to make an appointment with dermatology.

Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure.

Participants receive brochure, card advising how to make an appointment with dermatology, and reminder by telephone, text message or email in one week to perform SSE.

Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Number of participants who had ever conducted skin self-examination prior to study participation

Women having a screening mammogram completed a baseline self-report of prior skin self-examination prior to the intervention

Limitations of our study include a relatively short duration of follow-up resulting in a modest number of incident invasive melanoma cases and a lack of participant blinding of allocation to intervention arms.

Dr. June Robinson

change from baseline to 3 months in performance of skin self-examination Parallel: response rate

Women who received an educational brochure and a 1-week reminder call or email to complete SSE

Educational Intervention

Women performing skin self-examination as reported 3 months after the intervention

Number of Participants That Performed a Skin Self-Examination at 3-months

results of skin clinical examination and biopsy of clinically suspicious moles

Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.

Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure.

Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.

Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure.

Women who found a concerning mole at month 1 and month 3 and proceeded to have a skin examination by a dermatologist

Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion

Overall Study

All Drugs and Chemicals

Nicotine

Patients diagnosed with cancer (with at least one of the following ICD-10 diagnoses: C00-43; C46.1-99; D09)

Patients without cancer (without any of the following ICD-10 diagnoses: C00-99; D09; D30.1-9; D32-33; D35.2-4; D41.1-9; D44.3-5)

The intervention comprises 5-6 meetings during six weeks, and can be held in group or as an individual intervention. It is based on counselling and a clearly structured manual-based patient education programme taught by specially trained staff, and contains individual counselling on nicotine replacement therapy or other medical support, according to the level of dependence measured by the Fagerström test score. The first two weeks cover teaching sessions on: ambivalence and motivation, pros and cons of continuous smoking versus cessation, and a quit date is set between the 2. and 3. week. The last 3 sessions cover: risk situations, withdrawal symptoms and medical support for withdrawal symptoms, relapse prevention and how to handle a completely smoke-free life.

Intensive Smoking Cessation Intervention

Mette Rasmussen, PhD

Smoking accounts for approximately 30% of total cancer deaths each year. Even though former studies show that persons with a cancer diagnosis are less likely to smoke than the general population up to 50% of people who smoke and have lung cancer do not stop smoking after their diagnosis or frequently relapse after smoking cessation. Continued smoking leads to increased all-cause mortality, increased cancer-specific mortality, and decreased quality of life. It is well-known that cancer patients are interested in smoking cessation therefore smoking cessation interventions play an important role in the management of people with cancer.

This study will evaluate the effectiveness of an intensive smoking cessation interventions on cancer patients in real life. The project provides new knowledge about smokers diagnosed with cancer.

This prospective register-based cohort study including smokers attending an intensive smoking cessation intervention (the Gold Standard Programme (GSP)) from 2006-2017 in Denmark. The GSP is a manualised, patient education programme taught by specially trained staff, including pharmacologic strategies.

Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer

The Gold Standard Programme (GSP) for Smoking Cessation: Effectiveness in Smokers With and Without Cancer - a Prospective Cohort Study

Counsellor observed smoking status, questionnaire completed by counsellor

Self-reported smoking status, questionnaire completed by telephone interview

Self-reported patient-satisfaction, questionnaire completed by telephone interview

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Skin Self-Examination Education During Mammography	NCT03512457	Melanoma	Minimal Interve... Intensive Inter...	18 Years -	Northwestern University
Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer	NCT04198688	Tobacco Smoking Cancer Tobacco Cessati...	Intensive Smoki...	18 Years -	Bispebjerg Hospital
Skin Self-Examination Education During Mammography	NCT03512457	Melanoma	Minimal Interve... Intensive Inter...	18 Years -	Northwestern University

Spots Global Cancer Trial Database for intensive intervention