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

Primary Purpose

Cancer of the Head and Neck

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
My Journey AHead
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer of the Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fox Chase Cancer Center - Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

My Journey AHead

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2015
Last Updated
February 22, 2021
Sponsor
Fox Chase Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02442336
Brief Title
A Web-Based Multimedia Intervention for Head and Neck Cancer Patients
Official Title
A Web-based Multimedia Intervention for Head and Neck Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2012 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
November 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Head and Neck

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
My Journey AHead
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
My Journey AHead
Intervention Description
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 Outcome Measure Information:
Title
Patient Distress
Description
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.
Time Frame
Up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Fang, PhD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22518350
Citation
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. doi: 10.1007/s12553-012-0020-9. Epub 2012 Feb 14.
Results Reference
result
PubMed Identifier
33384959
Citation
Fang CY, Galloway TJ, Egleston BL, Bauman JR, Ebersole B, Chwistek M, Buhler JG, Longacre ML, Ridge JA, Manne SL, Manning C. Development of a Web-Based Supportive Care Program for Patients With Head and Neck Cancer. Front Oncol. 2020 Dec 15;10:602202. doi: 10.3389/fonc.2020.602202. eCollection 2020.
Results Reference
derived

Learn more about this trial

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

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