CancerNCT02830061
The Experience of TYAC Offered Ovarian Tissue Cryopreservation
An observational study of Cancer and Fertility, run by University of Oxford.
Trial summary
This study looks at the experiences of teenagers and young adults who have been offered ovarian tissue cryopreservation prior to cancer treatment as a result of their cancer and/or cancer treatment putting them at moderate-to-high risk of premature ovarian failure. Read more about this study
- Who is it for?
- Ages 13 to 25 years, women only
- What is being tested?
- Interviews
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Sep 2018
- 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 13 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: TYAC who have been offered OTC due to moderate-to-high risk of premature ovarian failure due to their cancer and/or cancer treatment.
Who may be able to join
- Aged 11-25 at time of procedure and aged 13+ at time of interview. Due to the short amount of time OTC has been available, there will be no time limit on how long ago the procedure took place.
- Received a cancer diagnosis carrying a moderate-high risk of premature ovarian failure as a result of the cancer and/or treatment.
- Have been offered ovarian cryopreservation by the ovarian cryopreservation service (participants will be included whether or not they have accepted the procedure).
- Has been confirmed as appropriate to approach by the consultant oncologist.
Who cannot join
- Under the age of 11 or over the age of 25 at time of procedure.
- Under the age of 13 at time of interview.
- Received a terminal diagnosis.
- The young person is unable to understand their diagnosis and/or fertility options, e.g. those with significant learning disabilities (guidance on this will be sought from the consultant oncologist as part of their approval).
- The young person is unaware that the procedure has taken place (guidance on this will be sought from the consultant oncologist as part of their approval).
About this study
Official title: An Interpretative Phenomenological Analysis Study Into the Experience of Teenagers and Young Adults Who Have Been Offered Ovarian Tissue Cryopreservation Prior to Cancer Treatment.
This study looks at the experiences of teenagers and young adults who have been offered ovarian tissue cryopreservation prior to cancer treatment as a result of their cancer and/or cancer treatment putting them at moderate-to-high risk of premature ovarian failure.
Read the detailed description
In the UK, around 2,200 teenagers and young adults (TYA) are diagnosed with cancer every year, and due to advances in treatments, survival rates have improved, with a current 5-year survival rate of more than 80%. This means there is a growing population of long-term survivors of childhood/adolescent cancer who may experience late effects of cancer and/or treatment. One such late effect is fertility impairment, which is a key issue for TYA with cancer. There are few clinical options currently available for the preservation of women's fertility in the UK; however, ovarian tissue cryopreservation (OTC) has been offered clinically at one primary treatment centre in the UK for the past 2-3 years. In an attempt to understand what it is like to be faced with potential infertility alongside a cancer diagnosis, previous studies have been conducted looking at young people's experiences of receiving, processing and living with this information, as well as their experiences of other FP techniques. However, no studies have looked at the experiences of cancer patients undergoing OTC. OTC differs to other FP options previously studied in several key ways, notably in that cancer treatment need not be delayed for it to go ahead, and it can be carried out with pre-pubertal females. This may mean that aspects of the process surrounding OTC are experienced differently to other FP options, and that OTC needs to be understood as a separate phenomenon. Although OTC is currently offered to women from birth to the age of 40 in the UK, the different experience of cancer and infertility across the lifespan necessitates a more specific focus for this study. TYA have been chosen as an understudied population, with more research needed to increase understanding of their unique psychosocial needs and their experience of health systems. Further, focusing on TYAC may capture individuals who have not started puberty and would therefore benefit from the introduction of this new technique by being unable to undergo other FP options.
The purpose of this research is therefore to take into account gaps in the literature and attempt to better understand the issues surrounding undergoing OTC for TYAC from the subjective experience of the individual.
- Being tested
- Interviews
- Keywords
- Cancer, Teenage, Young Adult, Fertility, Cryopreservation, Experience
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsOther
Individual semi-structured interviews for 30-60 minutes using an interview schedule developed from an interpretative phenomenological analysis framework.
| Study group | Role | What they receive |
|---|---|---|
| TYAC | Teenagers and young adults who have received a cancer diagnosis which puts them at moderate-to-high risk of fertility impairment. Semi-structured interviews will take place with each individual participant. Receives: Other: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual semi-structured interviews about the experiences of Teenagers and Young Adults with Cancer undergoing OTC
Measured: up to 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Rebekah Tennyson, DClinPsy, Principal investigator, Oxford Health NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830061
- Sponsor's protocol ID
- 12019
- Status last verified
- Oct 2019
- First submitted
- 8 Jul 2016
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interpretative Phenomenological Analysis Study Into the Experience of Teenagers and Young Adults Who Have Been Offered Ovarian Tissue Cryopreservation Prior to Cancer Treatment.
- ClinicalTrials.gov ID
- NCT02830061
- Acronym / sponsor ID
- 12019
- Keywords
- Cancer, Teenage, Young Adult, Fertility, Cryopreservation, Experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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 study looks at the experiences of teenagers and young adults who have been offered ovarian tissue cryopreservation prior to cancer treatment as a result of their cancer and/or cancer treatment putting them at moderate-to-high risk of premature ovarian failure.
Detailed description
In the UK, around 2,200 teenagers and young adults (TYA) are diagnosed with cancer every year, and due to advances in treatments, survival rates have improved, with a current 5-year survival rate of more than 80%. This means there is a growing population of long-term survivors of childhood/adolescent cancer who may experience late effects of cancer and/or treatment. One such late effect is fertility impairment, which is a key issue for TYA with cancer. There are few clinical options currently available for the preservation of women's fertility in the UK; however, ovarian tissue cryopreservation (OTC) has been offered clinically at one primary treatment centre in the UK for the past 2-3 years. In an attempt to understand what it is like to be faced with potential infertility alongside a cancer diagnosis, previous studies have been conducted looking at young people's experiences of receiving, processing and living with this information, as well as their experiences of other FP techniques. However, no studies have looked at the experiences of cancer patients undergoing OTC. OTC differs to other FP options previously studied in several key ways, notably in that cancer treatment need not be delayed for it to go ahead, and it can be carried out with pre-pubertal females. This may mean that aspects of the process surrounding OTC are experienced differently to other FP options, and that OTC needs to be understood as a separate phenomenon. Although OTC is currently offered to women from birth to the age of 40 in the UK, the different experience of cancer and infertility across the lifespan necessitates a more specific focus for this study. TYA have been chosen as an understudied population, with more research needed to increase understanding of their unique psychosocial needs and their experience of health systems. Further, focusing on TYAC may capture individuals who have not started puberty and would therefore benefit from the introduction of this new technique by being unable to undergo other FP options.
The purpose of this research is therefore to take into account gaps in the literature and attempt to better understand the issues surrounding undergoing OTC for TYAC from the subjective experience of the individual.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TYAC | – | Other: InterviewsTeenagers and young adults who have received a cancer diagnosis which puts them at moderate-to-high risk of fertility impairment. Semi-structured interviews will take place with each individual participant. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- TYAC who have been offered OTC due to moderate-to-high risk of premature ovarian failure due to their cancer and/or cancer treatment.
Key inclusion criteria (4 listed)
- Aged 11-25 at time of procedure and aged 13+ at time of interview. Due to the short amount of time OTC has been available, there will be no time limit on how long ago the procedure took place.
- Received a cancer diagnosis carrying a moderate-high risk of premature ovarian failure as a result of the cancer and/or treatment.
- Have been offered ovarian cryopreservation by the ovarian cryopreservation service (participants will be included whether or not they have accepted the procedure).
- Has been confirmed as appropriate to approach by the consultant oncologist.
Key exclusion criteria (5 listed)
- Under the age of 11 or over the age of 25 at time of procedure.
- Under the age of 13 at time of interview.
- Received a terminal diagnosis.
- The young person is unable to understand their diagnosis and/or fertility options, e.g. those with significant learning disabilities (guidance on this will be sought from the consultant oncologist as part of their approval).
- The young person is unaware that the procedure has taken place (guidance on this will be sought from the consultant oncologist as part of their approval).
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 |
|---|---|---|
| InterviewsIndividual semi-structured interviews for 30-60 minutes using an interview schedule developed from an interpretative phenomenological analysis framework. | Other | TYAC |
Primary outcome
Individual semi-structured interviews about the experiences of Teenagers and Young Adults with Cancer undergoing OTC
Time frame: up to 60 min
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 24 Oct 2019.
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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.
Rebekah Tennyson, DClinPsy principal investigator
Oxford Health NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Fertility, run by University of Oxford.
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 4 inclusion and 5 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 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Individual semi-structured interviews about the experiences of Teenagers and Young Adults with Cancer undergoing OTC (time frame: up to 60 min). 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 24 Oct 2019.