Expired Study
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Philadelphia, Pennsylvania 19111


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

IRB11822


NCT ID:

NCT02442336


Secondary ID:


Study Acronym:


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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Fox Chase Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

80


Enrollment Type:

Actual


Overall Contact Information

Official Name:Carolyn Fang, PhD
Principal Investigator
Fox Chase Cancer Center

Study Dates

Start Date:June 15, 2012
Completion Date:December 2018
Completion Type:Anticipated
Primary Completion Date:August 30, 2016
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 6, 2018
First Received Date:March 18, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Patient Distress
Time Frame:Up to 26 weeks
Safety Issues:False
Description:Psychological distress will be assessed using the Brief Symptom Inventory and the Impact of Events Scale

Study Interventions

Intervention Type:Behavioral
Name:My Journey AHead
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.
Arm Name:My Journey AHead

Study Arms

Study Arm Type:Experimental
Arm Name:My Journey AHead
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Fox Chase Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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. Epub 2012 Feb 14.
PMID:22518350

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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