The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life
NCT Number: NCT06551857
Acronym: CaSPiN
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cancer|Hearing Loss Ototoxic|Cognitive Decline|Quality of Life
Interventions: OTHER: Chemotherapy, chemoradiation, radiation therapy
Sponsor: Turku University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2030-12-31
Locations: Turku University Hospital, Turku, Varsinais-Suomi, 20521, Finland

Summary:
The study will assess the effect of cancer treatments on speech perception in noise, cognition, and hearing-related quality of life by monitoring 200 cancer patients receiving standard care for their underlying malignancy.

Primary Outcome Measures: Speech perception in noise, The treatment-related change in speech perception in noise (in decibel signal-to-noise ratio (db SNR)) from baseline to first follow-up at 3-4 months after the end of the treatment., 4 months
Secondary Outcome Measures: Long-term effects on speech perception in noise, Treatment-related long-term changes in speech perception in noise (in decibel signal-to-noise ratio (dB SNR)) measured with the Finnish matrix sentence test, 3 years|Short- and long-term effects on high frequency hearing, Treatment-related changes in high frequency (8-16kHz) hearing thresholds, 3 years|Hearing-related quality of life - Sound quality, Treatment-related changes in hearing related quality of life measured using the total score from Speech, Spatial, and Qualities 12 question questionnaire (SSQ-12). Responses are given with a VAS scale from 0 to 10, with 10 indicating perfect hearing performance and 0 worst possible performance. Range for total scores is 0-120, and decrease in scores indicates deterioration in hearing-related quality of life., 3 years|Hearing-related quality of life - Fatigue, Treatment-related changes in hearing-related fatigue are measured using the total score from Vanderbilt Fatigue Scale for Adults (10 question version, VFS-A-10). Responses are given in a 5-point Likert scale. The range for total scores is 0-40 with higher scores indicating more fatigue / worse score. An increase in the total score indicates increased listening-related fatigue., 3 years|Hearing-related quality of life - Tinnitus, Treatment-related changes in tinnitus symptoms are measured using the total score from Tinnitus Handicap Inventory (THI). The questionnaire provides a total score between 0 and 100, with larger score indicating more tinnitus-related handicap. An increase in the total score indicates increased tinnitus-related handicap., 3 years|Treatment-related changes in brain glucose metabolism, Treatment-related brain changes are evaluated from the FDG PET by assessing the voxel-wise mean change in the standardized uptake value ratios (SUVRs) from baseline to follow-up. Decrease in SUVRs indicates treatment-related decrease in brain glucose metabolism., 3 years
Other Outcome Measures: Treatment-related changes in cognition, Treatment-related changes in cognition are evaluated using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire. Responses are given in a five-point Likert-type scale and are presented as subscale scores for four domains: perceived cognitive impairments, impact of perceived cognitive impairments on quality of life, comments from others, and perceived cognitive abilities. Higher score indicates better perceived performance., 3 years