Cancer of the Head and Neck
Conditions
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.
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.
Interventions
BEHAVIORALMy 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.
Sponsors
Fox Chase Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| My Journey AHead Participants were provided access to a web-base intervention that included several modules on oral care, stress and coping, nutrition, and pain management. | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 6 patients assisted with the intervention development only. | 6 |
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Of the 74 who consented, 19 did not complete baseline assessment and were withdrawn from the study. | 19 |
Baseline characteristics
| Characteristic | My Journey AHead |
|---|---|
| Age, Continuous | 61.1 Years STANDARD_DEVIATION 9.76 |
| Brief Symptom Inventory-18 | 67.04 units on a scale STANDARD_DEVIATION 4.123 |
| Cancer Behavior Inventory (CBI-B) | 92.25 units on a scale STANDARD_DEVIATION 12.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 50 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
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.
Time frame: Up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Web-Based Intervention | Patient Distress | 66.16 units on a scale | Standard Deviation 4.77 |