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

• Sponsor: Fox Chase Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02442336
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arm: 1
• Actual Duration (Months): 101.1
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of the Head and Neck	Behavioral: My Journey AHead	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Web-based Multimedia Intervention for Head and Neck Cancer Patients
• Actual Study Start Date: Jun 15, 2012
• Actual Primary Completion Date: Aug 31, 2017
• Actual Study Completion Date: Nov 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: My Journey AHead 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; 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.

Outcome Measures

Primary Outcome Measures

1. Patient Distress [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497

Sponsors and Collaborators

• Fox Chase Cancer Center

Investigators

• Principal Investigator: Carolyn Fang, PhD, Fox Chase Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 3, 2015

More Information

Publications

None provided.

• Responsible Party: Fox Chase Cancer Center
• ClinicalTrials.gov Identifier: NCT02442336
• Other Study ID Numbers: IRB11822
• First Posted: May 13, 2015
• Last Update Posted: Mar 17, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

Participant Flow

Arm/Group Title	My Journey AHead
Arm/Group 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. My Journey AHead: 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.
Period Title: Overall Study
STARTED	80
Developmental Phase	6
Evaluation Phase	74
Provided Access to Intervention	55
COMPLETED	44
NOT COMPLETED	36

Baseline Characteristics

Arm/Group Title	My Journey AHead
Arm/Group Description	Participants were provided access to a web-base intervention that included several modules on oral care, stress and coping, nutrition, and pain management.
Overall Participants	55
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61.1 (9.76)
Sex: Female, Male (Count of Participants)
Female	14 25.5%
Male	41 74.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 10.9%
White	49 89.1%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	55 100%
Brief Symptom Inventory-18 (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	67.04 (4.123)
Cancer Behavior Inventory (CBI-B) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	92.25 (12.70)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Web-Based Intervention
Arm/Group Description	Participants were provided access to a web-base intervention that included several modules on oral care, stress and coping, nutrition, and pain management.
Measure Participants	44
Mean (Standard Deviation) [units on a scale]	66.16 (4.77)

Adverse Events

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).
Adverse Event Reporting Description	Adverse events due to clinical treatment or medical management of the patient's disease were not specifically collected in this behavioral study, unless the patient reported it to the study team. We did not obtain IRB approval to conduct a medical chart review for incidence of treatment-related adverse events.
Arm/Group Title	My Journey AHead
Arm/Group 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. My Journey AHead: 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.
All Cause Mortality
	My Journey AHead
	Affected / at Risk (%)	# Events
Total	0/55 (0%)
Serious Adverse Events
	My Journey AHead
	Affected / at Risk (%)	# Events
Total	0/55 (0%)
Other (Not Including Serious) Adverse Events
	My Journey AHead
	Affected / at Risk (%)	# Events
Total	50/55 (90.9%)
Psychiatric disorders
Elevated distress	50/55 (90.9%)	50

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.