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

Not Applicable

Completed

• Conditions: Cancer of the Head and Neck
• Interventions: Behavioral: My Journey AHead

• Registration Number: NCT02442336
• Lead Sponsor: Fox Chase Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-06-15
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-05-10
• Study First Posted: 2015-05-13
• Primary Completion: 2017-08-31
• Study Completion: 2020-11-18
• Results First Submitted: 2020-11-23
• Results First Submitted QC: 2020-12-28
• Results First Posted: 2021-01-22
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
My Journey AHead	My Journey AHead	Several internet modules will be developed to address mouth and swallowing concerns, oral care, healthy eating, speech problems, coping with cancer, pain management, and physical therapy.

Primary Outcome Measures

Name	Time	Method
Patient Distress	Up to 6 weeks	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.

Trial Locations

Locations (1)

Fox Chase Cancer Center - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States