Trial Outcomes & Findings for A Web-Based Multimedia Intervention for Head and Neck Cancer Patients (NCT NCT02442336)

Last Updated: 2021-03-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

Up to 6 weeks

Results posted on

2021-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	80
Overall Study Developmental Phase	6
Overall Study Evaluation Phase	74
Overall Study Provided Access to Intervention	55
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.
Overall Study 6 patients assisted with the intervention development only.	6
Overall Study Of the 74 who consented, 19 did not complete baseline assessment and were withdrawn from the study.	19
Overall Study Lost to Follow-up	11

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	My Journey AHead n=55 Participants Participants were provided access to a web-base intervention that included several modules on oral care, stress and coping, nutrition, and pain management.
Age, Continuous	61.1 Years STANDARD_DEVIATION 9.76 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants
Brief Symptom Inventory-18	67.04 units on a scale STANDARD_DEVIATION 4.123 • n=5 Participants
Cancer Behavior Inventory (CBI-B)	92.25 units on a scale STANDARD_DEVIATION 12.70 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks

Outcome measures

Outcome measures
Measure	Web-Based Intervention n=44 Participants Participants were provided access to a web-base intervention that included several modules on oral care, stress and coping, nutrition, and pain management.
Patient Distress	66.16 units on a scale Standard Deviation 4.77

Adverse Events

My Journey AHead

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	My Journey AHead n=55 participants at risk 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.
Psychiatric disorders Elevated distress	90.9% 50/55 • Number of events 50 • 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 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.

Additional Information

Carolyn Fang

Fox Chase Cancer Center

Phone: 215-728-4062

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place