Cancer of the Head and Neck Surviors, Head and Neck Cancer Survivors
Conditions
Keywords
survivorship, quality of life, cisplatin, radiation, head and neck cancer, hearing loss, ototoxicity
Brief summary
To evaluate the effectiveness, feasibility, acceptability, and appropriateness of an ototoxicity screening protocol among head and neck (H&N) cancer patients followed in survivorship clinic that received cisplatin-based chemoradiation therapy (CRT).
Interventions
OTHEROtotoxicity Screening Protocol
The ototoxicity screening protocol contains a functional and objective component. The functional component is the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S). The objective component will be pure tone audiometry. A 2 kHz tone at 40 dB will play through over-the-ear headphones and subjects will indicate whether they heard it.
Sponsors
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Washington University School of Medicine
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
* Adult (≥ 18 years old) * H&N cancer patients will be eligible for inclusion if they have previously undergone cisplatin-based CRT or radiotherapy, including proton therapy, intensity-modulated radiation therapy, and adaptive radiotherapy-surgery with curative intent (i.e., definitive, neoadjuvant, or adjuvant) or definitive surgery with neoadjuvant or adjuvant radiation.
Exclusion criteria
* Patient has been evaluated by an audiologist within the past 12 months * Use of a hearing aid * Received a cochlear implant * Cannot complete simple forms in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of participants who complete audiologic follow-up | Through completion of follow-up (estimated to be 6 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure | Before survivorship clinic visit (Day 1) | -Contains 4 statements about the proposed intervention that are scored on a five-point Likert scale (1 indicates the participant completely disagrees, 5 indicates completely agrees). A score greater than or equal to 4 will indicate the intervention is acceptable. |
| Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure | Before survivorship clinic visit (Day 1) | -Contains 4 statements about the proposed intervention that are scored on a five-point Likert scale (1 indicates the participant completely disagrees, 5 indicates completely agrees). A score greater than or equal to 4 will indicate the intervention is appropriate. |
| Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure | Before survivorship clinic visit (Day 1) | -Contains 4 statements about the proposed intervention that are scored on a five-point Likert scale (1 indicates the participant completely disagrees, 5 indicates completely agrees). A score greater than or equal to 4 will indicate the intervention is feasible. |
| Quality of life of participants as measured by the University of Washington Quality of Life Questionnaire (UW-QOL) | After survivorship clinic visit (Day 1) | -This questionnaire contains 16 items on morbidities associated with H&N cancer treatment. Twelve items are graded on a 5-point Likert scale. One question lists treatment-related morbidities and ask participants to identify their top three most important issues. The last three questions evaluate global QoL. It is scored on a scale from 0 (worst) to 100 (best). However, UW-QOL does not include symptoms of ototoxicity. Therefore, the investigators will modify it to include tinnitus and hearing loss as additional 5-point Likert scale questions and morbidities in the rank order question. |
| Functional social support as measured by the Duke-UNC Functional Social Support Questionnaire | After survivorship clinic visit (Day 1) | It has been validated for use in populations of cancer patients and cancer survivors. 5 questions are presented using a Likert scale from 0-2, with higher scores indicating a higher level of social support. |
| Functional hearing loss of participants as measured by the Situational Management Questionnaire (SESMQ) | After survivorship clinic visit (Day 1) | -This questionnaire contains 20 situations. Participants rate each situation according to their ability to hear in the given situation (hearing ability scale; SESMQH) and their confidence in managing the given situation (confidence scale; SESMQC). The score for each situation ranges from 0 (poor hearing/low confidence) to 10 (normal hearing/high confidence), totaling 200 points for each scale. The higher the score indicates less hearing loss to the participant. |
Countries
United States
Outcome results
None listed