NCT02442336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

January 22, 2021

Completed
Last Updated

March 17, 2021

Status Verified

February 1, 2021

Enrollment Period

5.2 years

First QC Date

March 18, 2015

Results QC Date

November 23, 2020

Last Update Submit

February 22, 2021

Conditions

Cancer of the Head and Neck

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 6 weeks

Study Arms (1)

My Journey AHead

EXPERIMENTAL

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.

Behavioral: My Journey AHead

Interventions

My Journey AHeadBEHAVIORAL

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.

My Journey AHead

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related Publications (2)

  • 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.

    PMID: 22518350RESULT

  • 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.

    PMID: 33384959DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Results Point of Contact

Title
Carolyn Fang
Organization
Fox Chase Cancer Center
carolyn.fang@fccc.edu
215-728-4062

Study Officials

  • Carolyn Fang, PhD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

May 13, 2015

Study Start

June 15, 2012

Primary Completion

August 31, 2017

Study Completion

November 18, 2020

Last Updated

March 17, 2021

Results First Posted

January 22, 2021

Record last verified: 2021-02

Locations

US(1)