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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
55
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.
Washington University School of Medicine
St Louis, Missouri, United States
Rate of participants who complete audiologic follow-up
Time frame: Through completion of follow-up (estimated to be 6 months)
Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure
-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.
Time frame: Before survivorship clinic visit (Day 1)
Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure
-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.
Time frame: Before survivorship clinic visit (Day 1)
Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure
-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.
Time frame: Before survivorship clinic visit (Day 1)
Functional hearing loss of participants as measured by the Situational Management Questionnaire (SESMQ)
-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.
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Time frame: After survivorship clinic visit (Day 1)
Quality of life of participants as measured by the University of Washington Quality of Life Questionnaire (UW-QOL)
-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.
Time frame: After survivorship clinic visit (Day 1)
Functional social support as measured by the Duke-UNC Functional Social Support Questionnaire
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.
Time frame: After survivorship clinic visit (Day 1)