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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04268329
• Other study ID #: 2017-0725
• Status: Terminated
• Phase: N/A
• Start date: August 16, 2016
• Est. completion date: June 18, 2020

Study information

• Verified date: April 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female subjects greater than 18 years of age.

2. Subjects that present to the UIC dept. of Otolaryngology-HNS with a head and neck cancer requiring surgery of the tongue, mandibulectomy, neck dissection, laryngectomy, or tracheostomy surgery and that have not previously had head and neck cancer resection surgery. (The surgeries listed are currently available on the website.)

3. One (1) family member of the cancer subject who will be treated at UIC for a head and neck cancer as noted in item 2 above, and who have not had a head and neck cancer surgery resection themselves. Patients undergoing treatment will remain eligible to participate independent of whether or not their family member takes part in the study.

4. Subjects that have access to the internet to view the study website either by using a desktop or laptop computer, a tablet or a smartphone.

5. Subjects who are willing to document their time on the website for study purposes.

6. Both English and Spanish speaking subjects who are literate and are able to read from a computer screen.

7. Subjects that understand the purpose and procedures of the study, who wish to participate, and who sign the study consent.

Exclusion Criteria:

1. Subjects under 18 years of age.

2. Subjects who do not have a head and neck cancer, or a family member with recently diagnosed head and neck cancer, or who have already had a head and neck cancer resection surgery.

3. Subjects that do not have access to the internet.

4. Subjects that do not understand or are not willing to follow the procedures as outlined in the study consent.

5. Subjects and/or their family member who cannot read or are legally blind.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Educational website
A website is used to educate patients and family members about head and neck cancer.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (3)

Kasabwala K, Agarwal N, Hansberry DR, Baredes S, Eloy JA. Readability assessment of patient education materials from the American Academy of Otolaryngology--Head and Neck Surgery Foundation. Otolaryngol Head Neck Surg. 2012 Sep;147(3):466-71. doi: 10.1177/0194599812442783. Epub 2012 Apr 3. — View Citation

López-Jornet P, Camacho-Alonso F. The quality of internet sites providing information relating to oral cancer. Oral Oncol. 2009 Sep;45(9):e95-8. doi: 10.1016/j.oraloncology.2009.03.017. Epub 2009 May 19. — View Citation

Rice RE. Influences, usage, and outcomes of Internet health information searching: multivariate results from the Pew surveys. Int J Med Inform. 2006 Jan;75(1):8-28. Epub 2005 Aug 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the change in knowledge of head and neck cancer procedures before and after participants use of the study head and neck cancer website.	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.	4 weeks
Secondary	The correlation between the use of an instructional head and neck cancer website and knowledge about head and neck cancer as measured by a study questionnaire.	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.	4 weeks