NCT02442336

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

Completed NA Results posted Last updated 17 March 2021

What this trial tests

NA trial testing My Journey AHead in Cancer of the Head and Neck in 80 participants. Completed in 18 November 2020.

Timeline

15 June 2012

Primary endpoint
31 August 2017

18 November 2020

Quick facts

Lead sponsor	Fox Chase Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	80
Start date	15 June 2012
Primary completion	31 August 2017
Estimated completion	18 November 2020
Sites	1 location across United States

Drugs / interventions tested

• My Journey AHead

Conditions studied

• Cancer of the Head and Neck — all drugs for Cancer of the Head and Neck →

Sponsor

Fox Chase Cancer Center — full company profile →

Who can join

18 and older, any sex, with Cancer of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Distress Primary · 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 hav

Group	Value	95% CI
Web-Based Intervention	66.16	± 4.77

Adverse events — posted to ClinicalTrials.gov

Time frame: A 3- to 6-week period during which participants were on-study (i.e. consented, completed baseline assessment, provided access to the intervention, and completed program evaluation).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

My Journey AHead

Serious: 0/55 (0%)

Deaths: 0/55

Other adverse events (1 terms — click to expand)

Reaction	System	My Journey AHead
Elevated distress	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT02442336 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development of a Web-Based Supportive Care Program for Patients With Head and Neck Cancer.
   Fang CY, Galloway TJ, Egleston BL, Bauman JR, et al · · 2020 · cited 10× · PMID 33384959 · DOI 10.3389/fonc.2020.602202