NCT04268329

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2016

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2020

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

3.8 years

First QC Date

January 30, 2020

Last Update Submit

April 6, 2021

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

    4 weeks

Study Arms (2)

Educational website: Patient

OTHER

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.

Other: Educational website

Educational website: Family member

OTHER

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.

Other: Educational website

Interventions

Educational websiteOTHER

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

Also known as: Educational Website: Patient, Educational Website: Family Member
Educational website: Family memberEducational website: Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects greater than 18 years of age.
  • 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.)
  • 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.
  • 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.
  • Subjects who are willing to document their time on the website for study purposes.
  • Both English and Spanish speaking subjects who are literate and are able to read from a computer screen.
  • Subjects that understand the purpose and procedures of the study, who wish to participate, and who sign the study consent.

You may not qualify if:

  • Subjects under 18 years of age.
  • 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.
  • Subjects that do not have access to the internet.
  • Subjects that do not understand or are not willing to follow the procedures as outlined in the study consent.
  • Subjects and/or their family member who cannot read or are legally blind.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related 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.

    PMID: 22473833BACKGROUND

  • 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.

    PMID: 19457707BACKGROUND

  • 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.

    PMID: 16125453BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Virginie Achim, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant Professor

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 13, 2020

Study Start

August 16, 2016

Primary Completion

June 18, 2020

Study Completion

June 18, 2020

Last Updated

April 9, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)