Clinical trial NCT04268329: Evaluating the Use of an Informational Head and Neck Cancer Website.
Official title: Evaluating the Use of an Informational Head and Neck Cancer Website for Patient and Family Education
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluating the change in knowledge of head and neck cancer procedures before and after participants use of the study head and neck cancer website.
timeFrame: 4 weeks
Secondary outcomes:
measure: 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.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Virginie Achim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lopez-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.
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. doi: 10.1016/j.ijmedinf.2005.07.032. Epub 2005 Aug 24.