A Web-Based Multimedia Intervention for Head and Neck Cancer Patients

Cancer of the Head and Neck Clinical Trial

Official title:

A Web-based Multimedia Intervention for Head and Neck Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442336
• Other study ID #: IRB11822
• Status: Completed
• Phase: N/A
• Start date: June 15, 2012
• Est. completion date: November 18, 2020

Study information

• Verified date: February 2021
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal is to develop and examine the acceptability of a web-based (Internet) intervention program for patients with head and neck cancer who have recently completed radiation therapy.

Description:

The overall goal is to develop and examine the acceptability of a theory-guided, web-based multimedia intervention program for head and neck cancer patients who have recently completed radiation therapy. The effects of this intervention on patients' quality of life (QOL) will also be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 18, 2020
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx

• Are receiving or have completed radiation therapy within in the past 12 months

Exclusion Criteria:

• Inability to read and/or communicate in English

• Head and neck cancers of non-squamous histology (e.g., adenoid cystic carcinoma, adenocarcinoma, sarcoma)

• Blindness or severity of visual impairment that precludes one's ability to view images/text

• Inability to provide informed consent

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Head and Neck Neoplasms

Intervention

Behavioral:
• My Journey AHead
The intervention program will contain information and interactive activities around swallowing concerns, proper oral care, healthy eating and nutrition, speech issues, stress and coping with cancer, and pain management.

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fang CY, Longacre ML, Manne SL, Ridge JA, Lango MN, Burtness BA. Informational Needs of Head and Neck Cancer Patients. Health Technol (Berl). 2012 Apr 1;2(1):57-62. Epub 2012 Feb 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Distress	Psychological distress will be assessed using the Brief Symptom Inventory-18. The Brief Symptom Inventory-18 (BSI-18) is an 18-item scale widely used to measure psychological distress. The BSI-18 yields a total score (Global Severity Index), which is a measure of overall psychological distress. Raw scores are converted to t-scores (range 0-100) based on gender-specific normative data from cancer patient populations. A t-score of 50 is equal to the mean of the population. Higher scores represent greater levels of distress. The BSI-18 provides a clinical case-rule classifying respondents who have a t-score score = 63 on the GSI as having clinically significant symptoms. Other studies have used a lower cutoff, with a GSI t-score = 57 recommended as a cutoff for clinically significant symptoms in a study of cancer patients.	Up to 6 weeks