Neoplasms

All Conditions

Head and Neck Neoplasms

Patients with a head and neck cancer will be asked to complete an 8 item questionnaire during their clinic visit. Patients will be shown the head and neck website (available in both English and Spanish) by a member of the study investigation team on a computer and also given the URL address to the study website. Patients will be asked to review the material on the website between their initial visit and there second follow-up visit. The time between visits will be between 1 and 4 weeks. Patients will be asked to record the number of times they visit the website and the time spent during each visit. Patients will be given a log sheet to document their use/time on the website. During the 2nd clinic visit patients will be asked to complete the same questionnaire that they completed during their initial study visit along with an additional 7 item survey. Following completion of the 2 documents, the patient's participation in the study will be completed.

A family member of a patient with a head and neck cancer will be asked to complete an 8 item questionnaire during their clinic visit. They will be shown the head and neck website (available in both English and Spanish) by a member of the study investigation team on a computer and also given the URL address to the study website. They will be asked to review the material on the website between their relatives initial visit and there second follow-up visit. The time between visits will be between 1 and 4 weeks. The family member will be asked to record the number of times they visit the website and the time spent during each visit. They will be given a log sheet to document their use/time on the website. During the 2nd clinic visit the family member will be asked to complete the same questionnaire that they completed during their initial study visit along with an additional 7 item survey. Following completion of the 2 documents, their participation in the study will be completed.

A website is used to educate patients and family members about head and neck cancer.

Educational website

Virginie Achim, MD

It can be difficult for head and neck cancer patients and their families to fully understand the impact that cancer procedures and treatments can have on the cancer patients life. Procedures used to treat head and neck cancer may result in significant changes to the patients' physical appearance and/or functional abilities (talking, eating, and breathing). The lack of understanding as it relates to the effects of cancer treatments can have a significant impact on the patients post-operative success.

In an effort to help educate head and neck cancer patients and their families during this difficult time, the UIC department of Otolaryngology-HNS has created an informational website. The website is designed to educate cancer patients and their families regarding various cancer treatments and therapies.

Head and neck cancer patients and their families often struggle to fully understand the degree to which cancer procedures and treatments may have on the cancer patient's life. The procedures involved in cancer treatment may result in significant changes to the patient's physical appearance and/or functional abilities (talking, eating, and breathing). Unfortunately, healthcare workers have a limited amount of time to spend educating their patients on all of the possibilities that may result from cancer related treatments. This lack of patient education and understanding can increase patient anxiety, compromise patient compliance, and result in less than optimum long-term outcomes.

Many patients are using the internet to educate themselves and to help them make their health care related decisions. However, for head and neck cancer patients, the information available on head and neck cancer websites is somewhat limited. In many cases, the information fails to provide adequate details as to the life changing, and at times disfiguring, results that head and neck cancer related treatments can have.

In an effort to help educate head and neck cancer patients and their families during this difficult time, the UIC department of Otolaryngology-HNS has created an informational website. The website includes information and educational videos about what to expect during the cancer treatment process. Specifically, the website is designed to educate cancer patients and their families on 1) the procedures that may be used to treat their specific cancer, 2) the side effects and post-operative hospital care of various treatments, 3) the physical changes that are possible as a result of their treatment, 4) functional changes that may occur as a result of their surgery/treatment, and 5) potential therapies that can be used to help improve their long-term outcome. The purpose of the website is to provide an educational and informative format, centered on head and neck cancer patients, that will help improve patient knowledge, understanding, and expectations during the course of cancer treatment and recovery.

Currently there are no studies that evaluate and or measure a change in patient/family member knowledge about head and neck cancer surgeries based on internet based information. However, there has been significant research related to the increased use of the internet for health care related decisions. These studies show that patients and families are more frequently turning to the internet and other forms of social media to learn about their diagnosis in order to make informed decisions about their medical care. Studies have also shown that websites are often written at a level well above the recommended reading level thereby inhibiting patient education.

3.0 Objectives/Aims

The objectives of this research are to evaluate 1) the change in subject knowledge before and after using the study head and neck cancer website, and 2) to determine whether a head and neck website is beneficial to study subjects in providing information that will result in improved compliance and ultimately long-term outcomes. Specifically, the PI's will be evaluating how the website educates cancer patients and their families on 1) the procedures that may be used to treat their specific cancer, 2) the side effects and post-operative care of various treatments, 3) the physical changes that are possible as a result of their treatment, 4) functional changes that may occur as a result of their surgery/treatment, and 5) potential therapies that can be used to minimize the physical and functional changes that may result from their cancer care.

Patient's with head and neck cancer and 1 of their family members will be asked to visit an instructional head and neck cancer website to learn about what they might expect during the process of head and neck cancer treatment.

Evaluating the Use of an Informational Head and Neck Cancer Website.

Evaluating the Use of an Informational Head and Neck Cancer Website for Patient and Family Education

Case Report Forms (CRF), questionnaires, and surveys will be assigned a code number that corresponds to the participant. A copy of the master list with subject name, MRN, and code number will be maintained by the study investigator in a separate file on a secured, password protected, encrypted UI Health System server. The coded data, without PHI, will be maintained on study personnel laptop computers. A hard copy of each subject's consent will be kept by the PI in a locked office in the EEI clinic Rm 3.87.

Study data will be gathered from the cancer subjects medical record, directly from study subjects, and from completed surveys and questionnaires. Data with the linking code for each subject will be kept in an excel file database on an encrypted password protected laptop computer. Only approved study personnel will have access to the study data and the Master List.

Participants will be asked to complete an 8 item questionnaire measurement tool (Website Study Questionnaire) about head and neck cancer procedures during their initial study visit. The questionnaire will be used to measure the participant's understanding of head and neck procedures before and after the use of an educational website. The participants will be provided a link to an educational website about head and neck cancer and they will be asked to view the website on several occasions in order to learn more about head and neck cancer procedures and what they or their family member might experience during and after their treatments. One to 4 weeks after the initial visit the participant will be asked to once again complete the same 8 item questionnaire. An increase in knowledge will be measured by counting the number of correct answers on the questionnaires before and after use of the website.

Participants will be asked to record the time and date they visit the website onto a provided study log sheet. The number of correct answers recorded by participants during the completion of the second visit questionnaire will be correlated to the amount of time the participant spent using the educational website. It is expected that participants that visit and spend the greatest amount of time reviewing the website will have a greater understanding (a better questionnaire score) than participants that fail to use the website or who use of the website minimally.

Participants will also complete an Otolaryngology/Head and Neck Surgery Website Study Survey that will be used to qualitatively measure if the participant found the educational website to be useful in their understanding of head and neck cancer.

University of Illinois at Chicago

Assitant Professor

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Lobular

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Adenocarcinoma

Breast Carcinoma In Situ

Participants randomized to the intervention group will receive a breast reconstruction decision aid. Participants will be provided instructions on how to access and navigate the decision aid. Participants will access the decision aid through a website link that is emailed to them or on a tablet at the study site.

Participants randomized to the control group will receive two website pages on healthy living with breast cancer from an educational website. Participants will be provided instructions on how to access and navigate the website pages. Participants will access the website pages through a link that is emailed to them or on a tablet at the study site.

The breast reconstruction decision aid is a web-based, interactive tool that participants will use after the first breast surgery visit and before a plastic surgery visit or surgery. The decision aid provides information about post-mastectomy breast reconstruction and helps the participant clarify their preferences related to the procedure.

Breast reconstruction decision aid

The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.

Decision making about whether to have breast reconstruction after mastectomy can be difficult, and previous studies have found that many women are not well informed about their options. Patient decision aids can improve decision quality for a variety of health conditions. This pilot randomized study seeks to determine how a patient decision aid about breast reconstruction affects the quality of decisions about reconstruction including patient knowledge, concordance between preferences and treatment, and decisional regret.

Enrolled participants will be randomized to 1 of 2 arms; participants may receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer.

Participants will complete up to three surveys; a baseline survey before viewing the decision aid or website, a second survey immediately after viewing the decision aid or website, and a third survey six months after surgery. Tablets will be made available to participants at the study site through which they can complete the surveys and view the decision aid or website. Participants will have the options of viewing the decision aid or website outside of the study site, and completing the three surveys electronically or on paper.

The baseline survey and second survey will each take approximately 45 minutes for participants to complete. The third survey will take approximately 30 minutes for participants to complete.

Participants enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.

Living Well After Breast Surgery

To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the number of patients enrolled per month.

To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the proportion of patients retained through the 6 month outcome assessment.

Change in knowledge (e.g. advantages and disadvantages) about breast reconstruction from baseline to post intervention measured by Decision Quality Instrument - Reconstruction Module.

Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Rating Scale.

Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Ranking Task.

Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Decisional Conflict Scale.

Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by treatment outcome recorded in patient electronic health record (EHR).

Regret with decision related to breast reconstruction at 6-month follow-up measured by Decisional Regret Scale.

Satisfaction with decision related to breast reconstruction at 6-month follow-up measured by Satisfaction with Decisions Scale.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating the Use of an Informational Head and Neck Cancer Website.	NCT04268329	Head and Neck C...	Educational web...	18 Years -	University of Illinois at Chicago
Evaluating the Use of an Informational Head and Neck Cancer Website.	NCT04268329	Head and Neck C...	Educational web...	18 Years -	University of Illinois at Chicago
Living Well After Breast Surgery	NCT03834532	Breast Cancer F... Stage I Breast ... Stage II Breast... Stage III Breas... Ductal Carcinom... Ductal Breast C... Lobular Breast ...	Breast reconstr... Educational web...	18 Years -	University of Texas at Austin

Spots Global Cancer Trial Database for educational website