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Clinical Trials/NCT02442336
NCT02442336
Completed
Not Applicable

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

Fox Chase Cancer Center1 site in 1 country80 target enrollmentJune 15, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer of the Head and Neck
Sponsor
Fox Chase Cancer Center
Enrollment
80
Locations
1
Primary Endpoint
Patient Distress
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2012
End Date
November 18, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Patient Distress

Time Frame: 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.

Study Sites (1)

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