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Completed

NCT Number: NCT02442336

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

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.

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Key information

Conditions

Cancer of the Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

My Journey AHead

Behavioral

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2020
First posted
May 13, 2015
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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