Quality of LifeNCT04281953
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
An observational study of Quality of Life and Cancer, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Cancer, Hearing Loss, Sensorineural
- What is being tested?
- High frequency audiometry, Short-Form 36-Item Questionnaire (SF-36) and Hearing handicap inventory for adults/elderly (HHIA/HHIE)
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2019to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People who have received platinum-based chemotherapy 0-5 years ago.
Who may be able to join
- 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
Who cannot join
- Pre-existing hearing issues
- Radiotherapy to the head and neck area
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
About this study
Official title: Long-term Ototoxicity in Cancer Survivors Treated With Chemotherapy and the Impact on Quality of Life
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.
Read the detailed description
The medical and technological advances in cancer research have caused a decline in cancer deaths in recent decades. For example, the 5-year survival rate now is above 80% for many adult cancers, including breast and testicular cancers. In breast cancer alone, the mortality rate has reduced 39% since 1989 and currently has a 5 year survival rate over 90%. Due to this increase in survival rates and the intensity of treatment, many face long-term physical and psychological challenges in survivorship. Cancer survivors may experience altered body image and changes in sexual health and energy levels in addition to distress, anxiety, the fear of recurrence and the chronic side effects of their treatment. The need to research the long-term effects of chemotherapy and the impact they have on quality of life is crucial.
There is a need to broaden research beyond the survival rates and address the need for support for those who are adapting to a life after cancer. Survivors are left with often permanent and possible life-debilitating effects from treatment. To date, there has been little research on the specific late effects of chemotherapy and the associated impact on quality of life.
Platinum-based chemotherapy, although highly effective, is known to cause ototoxicity, presenting often as permanent high frequency hearing loss and tinnitus. Hearing loss and tinnitus are associated with a higher risk of depression, social isolation and anxiety. The quality of social interactions for a person with hearing loss and tinnitus is diminished as taking part in conversations becomes challenging. This is particularly problematic as it means that the quality of life of these cancer survivors is reduced.
The impact hearing loss and tinnitus has on quality of life in cancer survivors remains unclear and under-studied. Because cancer therapies can potentially cause life-threatening side effects such as cardiotoxicity and nephrotoxicity, these become the priority. However, once these side acute effects subside, other long-term side effects remain and can permanently reduce quality of life. Cancer survivors may have already experienced a difficult journey from the diagnosis itself, the physical challenges of treatment and finally, remission. Re-adapting back to their previous life whilst in remission, but with added permanent side effects, both physically and psychologically, can be extremely difficult for some survivors.
Currently, there is little information and support offered to these patients who suffer from ototoxicity, potentially leading to many being undiagnosed and untreated. These patients can be affected by this toxicity for the rest of their lives, which can have a detrimental impact on their quality of life. It is essential that a deeper understanding and increased awareness of how hearing loss and tinnitus affects the quality of life of cancer survivors is sought to improve long-term symptoms management and support offered. This study aims to develop this and improve the support given to cancer survivors.
- Being tested
- High frequency audiometry, Short-Form 36-Item Questionnaire (SF-36), Hearing handicap inventory for adults/elderly (HHIA/HHIE), Tinnitus handicap inventory (THI)
- Medical subject headings
- Neoplasms, Hearing Loss, Sensorineural, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency audiometryDiagnostic test
Simple hearing test
Short-Form 36-Item Questionnaire (SF-36)Other
Questionnaire on quality of life (Short Form 36 Item- SF-36)
Hearing handicap inventory for adults/elderly (HHIA/HHIE)Other
Questionnaire on Hearing loss (Hearing handicap inventory for adults/elderly- HHIA/HHIE)
Tinnitus handicap inventory (THI)Other
Questionnaire on Tinnitus (Tinnitus Handicap Inventory)
| Study group | Role | What they receive |
|---|---|---|
| People with ototoxicity | People living with and beyond who experience ototoxicity as a result of chemotherapy Receives: Diagnostic Test: High frequency audiometry; Other: Short-Form 36-Item Questionnaire (SF-36); Other: Hearing handicap inventory for adults/elderly (HHIA/HHIE); Other: Tinnitus handicap inventory (THI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hearing loss
High frequency audiogram
Measured: Between 0-5 years
Secondary outcomes (3)
Quality of life Questionnaire SF-36 (short-form 36 item)
Questionnaire on quality of life, scale between 0-100 with 0 being bad quality of life and 100 being good
Measured: Between 0-5 years
Hearing Questionnaire HHIA/HHIE (hearing handicap inventory for adults/elderly)
Questionnaire on hearing loss scale from 0-100, 0 being no handicap and 100 being a big handicap
Measured: Between 0-5 years
Tinnitus Questionnaire THI (tinnitus handicap inventory)
Questionnaire on Tinnitus from 0-100, 0 being no handicap and 100 being a bit handicap
Measured: Between 0-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start5 Sep 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, International Stem Cell Forum
- Responsible party
- Sponsor
- Investigators
- David Baguley, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281953
- Sponsor's protocol ID
- 18074
- Status last verified
- Mar 2020
- First submitted
- 20 Feb 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be anonymised and made confidential, statistical analysis will be performed before data is shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Ototoxicity in Cancer Survivors Treated With Chemotherapy and the Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT04281953
- Acronym / sponsor ID
- 18074
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, International Stem Cell Forum
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The medical and technological advances in cancer research have caused a decline in cancer deaths in recent decades. For example, the 5-year survival rate now is above 80% for many adult cancers, including breast and testicular cancers. In breast cancer alone, the mortality rate has reduced 39% since 1989 and currently has a 5 year survival rate over 90%. Due to this increase in survival rates and the intensity of treatment, many face long-term physical and psychological challenges in survivorship. Cancer survivors may experience altered body image and changes in sexual health and energy levels in addition to distress, anxiety, the fear of recurrence and the chronic side effects of their treatment. The need to research the long-term effects of chemotherapy and the impact they have on quality of life is crucial.
There is a need to broaden research beyond the survival rates and address the need for support for those who are adapting to a life after cancer. Survivors are left with often permanent and possible life-debilitating effects from treatment. To date, there has been little research on the specific late effects of chemotherapy and the associated impact on quality of life.
Platinum-based chemotherapy, although highly effective, is known to cause ototoxicity, presenting often as permanent high frequency hearing loss and tinnitus. Hearing loss and tinnitus are associated with a higher risk of depression, social isolation and anxiety. The quality of social interactions for a person with hearing loss and tinnitus is diminished as taking part in conversations becomes challenging. This is particularly problematic as it means that the quality of life of these cancer survivors is reduced.
The impact hearing loss and tinnitus has on quality of life in cancer survivors remains unclear and under-studied. Because cancer therapies can potentially cause life-threatening side effects such as cardiotoxicity and nephrotoxicity, these become the priority. However, once these side acute effects subside, other long-term side effects remain and can permanently reduce quality of life. Cancer survivors may have already experienced a difficult journey from the diagnosis itself, the physical challenges of treatment and finally, remission. Re-adapting back to their previous life whilst in remission, but with added permanent side effects, both physically and psychologically, can be extremely difficult for some survivors.
Currently, there is little information and support offered to these patients who suffer from ototoxicity, potentially leading to many being undiagnosed and untreated. These patients can be affected by this toxicity for the rest of their lives, which can have a detrimental impact on their quality of life. It is essential that a deeper understanding and increased awareness of how hearing loss and tinnitus affects the quality of life of cancer survivors is sought to improve long-term symptoms management and support offered. This study aims to develop this and improve the support given to cancer survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with ototoxicity | – | Diagnostic Test: High frequency audiometry, Other: Short-Form 36-Item Questionnaire (SF-36), Other: Hearing handicap inventory for adults/elderly (HHIA/HHIE), Other: Tinnitus handicap inventory (THI)People living with and beyond who experience ototoxicity as a result of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who have received platinum-based chemotherapy 0-5 years ago.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Pre-existing hearing issues
- Radiotherapy to the head and neck area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High frequency audiometrySimple hearing test | Diagnostic test | People with ototoxicity |
| Short-Form 36-Item Questionnaire (SF-36)Questionnaire on quality of life (Short Form 36 Item- SF-36) | Other | People with ototoxicity |
| Hearing handicap inventory for adults/elderly (HHIA/HHIE)Questionnaire on Hearing loss (Hearing handicap inventory for adults/elderly- HHIA/HHIE) | Other | People with ototoxicity |
| Tinnitus handicap inventory (THI)Questionnaire on Tinnitus (Tinnitus Handicap Inventory) | Other | People with ototoxicity |
Primary outcome
Prevalence of hearing loss
Time frame: Between 0-5 years
High frequency audiogram
3 secondary outcomes
Quality of life Questionnaire SF-36 (short-form 36 item)
Time frame: Between 0-5 years
Hearing Questionnaire HHIA/HHIE (hearing handicap inventory for adults/elderly)
Time frame: Between 0-5 years
Tinnitus Questionnaire THI (tinnitus handicap inventory)
Time frame: Between 0-5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No. Data will be anonymised and made confidential, statistical analysis will be performed before data is shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Baguley, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Cancer, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hearing loss (time frame: Between 0-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.