Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

One group asked to read educational materials.

Group 2 use an educational computer program to learn about breast cancer risk and genetic testing without guidance.

Group 3 use the computer program with the guidance of a promotora.

Participants will be given a program to learn about breast cancer risk and genetic testing.

Arm 3 Only = Participants will use the program with the assistance of a promotora (female "promoter," community health worker, sometimes known as a lay health advisor).

Computer Program

Focus group discussion lasting about 60 to 90 minutes.

Focus Group

Printed materials will be given. The CD-ROM will be offered at the end of the study.

Written Materials

Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.

Questionnaires

Susan Peterson, PhD

This project will build upon prior, successful research on the effectiveness of an interactive computer disk with readable only memory (CD-ROM) for educating women about breast cancer and genetic risk. Prior studies found that an interactive CD-ROM for educating women about breast cancer risk and genetic testing was effective. The program was well received by lay persons and professionals. In a randomized controlled trial conducted at multiple sites, the CD-ROM intervention was highly effective in increasing knowledge, especially among women at low risk of carrying a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation.

Researchers now propose to expand the use of the interactive CD-ROM in two innovative ways. The overall goal of this proposal is to evaluate the program as a first-line educational approach for Hispanic women on the Texas-Mexico border, where educational resources about cancer genetics are limited. First, researchers will modify and adapt the program for a primarily Hispanic population, in order to make it culturally and linguistically appropriate to the needs of that audience.

Second, researchers will evaluate the program as a first-line educational method among women with a personal or family history of breast cancer. Researchers will compare the effectiveness of the CD-ROM when implemented with and without the guidance of a trained promotora, and in comparison with standard educational materials (usual care condition).

The specific aims of this study include:

Aim 1: To modify the interactive CD-ROM to: a) make it culturally and linguistically appropriate for Hispanic women residing along the Texas-Mexico border; b) reflect current knowledge about breast cancer genetics; c) add a module to help women prepare to discuss their family history and cancer risk with a health care provider (n=50 participants).

Aim 2: To conduct a randomized, controlled evaluation that compares the efficacy of the modified CD-ROM when used alone vs. when used with a promotora-assisted approach vs. standard written materials (n=414 participants).

This study will test ways to help improve Hispanic women's knowledge and understanding about breast cancer risk and genetic testing for inherited cancer risk. These methods include providing printed educational materials, using an educational computer program, and using the computer program with the assistance of a lay health worker (a promotora).

If you agree to take part in this study, you will complete a questionnaire that will ask about your personal health as well as your knowledge and attitudes toward cancer and genetic testing. After the questionnaire is completed, you will be randomly assigned (as in the roll of dice) to 1 of 3 study groups. One group will be asked to read educational materials. Another group will use an educational computer program to learn about breast cancer risk and genetic testing without guidance. Another group will use the computer program with the guidance of a promotora.

Each of the 3 study groups should take between 30 and 60 minutes to complete.

Immediately after participating in your assigned group, you will be asked to complete another questionnaire that will ask about your knowledge and attitudes toward cancer and genetic testing. You will also be contacted later by telephone to complete similar questionnaires at about 1 month and 6 months after your study visit. Some women will be asked to complete an additional questionnaire by telephone 1 week after reading the educational materials or the computer program, and researchers will ask for permission to audiotape this interview. It will take about 20 minutes to complete each of the questionnaires used in this study.

This is an investigational study. Up to 414 women will take part in this study.

Cancer Genetics CD-ROM for Hispanics

Interactive CD-ROM on Cancer Genetics for Hispanics

National Human Genome Research Institute (NHGRI)

National Institutes of Health (NIH)

M.D. Anderson Cancer Center

Digestive System Diseases

Symptoms and General Pathology

Adenoma

Colonic Neoplasms

Polyps

Pathological Conditions, Anatomical

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Photographies of polyps for creation of computer program

No study specific intervention. Still images of polyps are collected. Histopathological reports of the resected polyps will be evaluated in order to create a computer program.

Computer program

The aim of the study is to develop a computer program which is able to classify different entities of colorectal polyps on the basis of optical polyp features. In the end, the computer program shall differentiate between (i) hypeplastic polyps, (ii) adenomas and (iii) serrated adenomas .

In the first phase of the study a computer program will be established which aims to distinguish between the above mentions entities on the basis of optical features derived from still images. A machine learning apporach will be used for creating the program. Afterwards, in a second phase of the study, still images of 100 polyps (not used in the first phase) will be presented to the computer program. Quality of the computer program will be tested by calculating the accuracy for differentiating the three different polyp types. The gold standard for true polyp diagnoses will be based on histopathological diagnoses of the polyps. The same pictures of 100 polyps will also be presented to human experts. Experts will also predict histopathological diagnoses on the basis of optical polyps featurs. Accuracy of computer-decisions and human expert predictions will be compared. The establishment of a well- functioning computer program is the primary aim of the study.

Computer Assisted Selection of Serrated Adenomas and Neoplastic Polyps - a New Clinical DRAft

Computer Assisted Selection of Serrated Adenomas and Neoplastic Polyps - a New Clinical Draft

The predicted polyp histology (made optically by the computer program) will be assessed; the predicted diagnosis will be compared with the histopathological diagnosis (gold standard) after resection of the polyp;

Technical University of Munich

3 step process including person to person meeting and questionnaires taking about 30 minutes.

Interview

Michael A. Kallen, PhD

The goal of this research study is to collect information to plan how to design a computer program for cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care. Researchers want to learn how to make this program practical for use by future patients, caregivers, doctors, and nurses.

The Computer Program:

In this study, researchers will interview cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care.

The computer program will be designed to help doctors and nurses monitor the symptoms of patients. The program will also be designed to help doctors and nurses make decisions about how to care for patients.

Interview Session:

If you agree to take part in this study, you will be interviewed by a research staff member. The study chair may also attend the interview. The interview will be held at the Palliative Care outpatient clinic.

The interview session will be done in 3 steps, which are described below. Each step will take about 10 minutes.

First, you will read questionnaires about patient symptoms. These questionnaires are drafts of the ones that will be included in the software program.

You will then look at a draft of the computer program's layout.

Last, you will be interviewed. You will be asked to discuss your experiences as a patient or caregiver in reporting symptoms and health status to doctors and nurses. You will also be asked to discuss what might make the program more usable.

During the interview, you may also be asked to answer sample questions on the draft questionnaires and discuss how readable you think the questions are. For example, you will discuss your opinion about the font size, text placement, and color scheme.

Study Data:

The interview session will be audio-taped. To protect your confidentiality, only your first name will be used during the interview session. Patients and their caregivers will also be interviewed separately to protect privacy.

Patient responses will not be disclosed to caregivers, and caregiver responses will not be disclosed to patients. The patient's palliative care doctor will be told, however, if patients or caregivers show signs of emotional difficulties.

When the audio recording is transcribed (typed) by the research staff, all names will be coded so that no one can be identified by name. The audio recordings will be stored in password-protected files that are available only to the study chair and staff.

After the results of the study are published, the audio recordings will be destroyed by the study staff.

Length of Study:

Your study participation will be over after the interview session.

This is an investigational study.

Up to 26 participants will be enrolled in this study. This includes up to 9 patients and 9 caregivers in this part of the study, and up to 4 doctors and 4 nurses in a second part of the study. All will be enrolled at M. D. Anderson.

Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: A Qualitative Study

A Qualitative Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record

Through focused interviews with specific tasks: review PRO domains and questionnaires for the care mode; review user interface design and work flow; discuss user expectations of the system to assess the usability of a system's user interface design.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cancer Genetics CD-ROM for Hispanics	NCT00525980	Breast Cancer	Computer Progra... Focus Group Written Materia... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Cancer Genetics CD-ROM for Hispanics	NCT00525980	Breast Cancer	Computer Progra... Focus Group Written Materia... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Computer Assisted Selection of Serrated Adenomas and Neoplastic Polyps - a New Clinical DRAft	NCT03550625	Polyps Adenoma Colon Automatic Judge... Colonic Neoplas...	Computer progra...	18 Years - 99 Years	Technical University of Munich
Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: A Qualitative Study	NCT00878267	Advanced Cancer	Interview	21 Years -	M.D. Anderson Cancer Center
Computer Assisted Selection of Serrated Adenomas and Neoplastic Polyps - a New Clinical DRAft	NCT03550625	Polyps Adenoma Colon Automatic Judge... Colonic Neoplas...	Computer progra...	18 Years - 99 Years	Technical University of Munich
Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: A Qualitative Study	NCT00878267	Advanced Cancer	Interview	21 Years -	M.D. Anderson Cancer Center
Computer Assisted Selection of Serrated Adenomas and Neoplastic Polyps - a New Clinical DRAft	NCT03550625	Polyps Adenoma Colon Automatic Judge... Colonic Neoplas...	Computer progra...	18 Years - 99 Years	Technical University of Munich
Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: A Qualitative Study	NCT00878267	Advanced Cancer	Interview	21 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for computer program