Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Long-term Ototoxicity in Cancer Survivors Treated With Chemotherapy and the Impact on Quality of Life
1 other identifier
observational
20
1 country
1
Brief Summary
This project aims to explore, in depth, the burden of hearing loss and tinnitus on cancer survivors. Using semi-structured interviews, audiograms and a variety of validated questionnaires, the specific impact ototoxicity has on quality of life will be investigated. From this, we can identify the specific needs of patients experiencing hearing loss and tinnitus following chemotherapy and develop a tailored and personalised support system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 5, 2019
CompletedFirst Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
February 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedMarch 25, 2020
March 1, 2020
6 months
February 20, 2020
March 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of hearing loss
High frequency audiogram
Between 0-5 years
Secondary Outcomes (3)
Quality of life Questionnaire SF-36 (short-form 36 item)
Between 0-5 years
Hearing Questionnaire HHIA/HHIE (hearing handicap inventory for adults/elderly)
Between 0-5 years
Tinnitus Questionnaire THI (tinnitus handicap inventory)
Between 0-5 years
Study Arms (1)
People with ototoxicity
People living with and beyond who experience ototoxicity as a result of chemotherapy
Interventions
Questionnaire on quality of life (Short Form 36 Item- SF-36)
Questionnaire on Hearing loss (Hearing handicap inventory for adults/elderly- HHIA/HHIE)
Questionnaire on Tinnitus (Tinnitus Handicap Inventory)
Eligibility Criteria
People who have received platinum-based chemotherapy 0-5 years ago.
You may qualify if:
- Has had platinum-based chemotherapy between 0-5 years ago
- Has had at least 1 cycle- Was an adult (over 18) at the time of cancer diagnosis
You may not qualify if:
- Pre-existing hearing issues
- Radiotherapy to the head and neck area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nottinghamlead
- National Institute for Health Research, United Kingdomcollaborator
- International Stem Cell Forumcollaborator
Study Sites (1)
University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Baguley, PhD
University of Nottingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2020
First Posted
February 24, 2020
Study Start
September 5, 2019
Primary Completion
February 28, 2020
Study Completion
February 28, 2020
Last Updated
March 25, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
Data will be anonymised and made confidential, statistical analysis will be performed before data is shared.