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The Experience of TYAC Offered Ovarian Tissue Cryopreservation

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ClinicalTrials.gov Identifier: NCT02830061
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
University of Oxford

Brief 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.

Condition or disease Intervention/treatment
Cancer Fertility Other: Interviews

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.

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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.
Actual Study Start Date : July 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : September 2018

Group/Cohort Intervention/treatment
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.
Other: Interviews
Individual semi-structured interviews for 30-60 minutes using an interview schedule developed from an interpretative phenomenological analysis framework.




Primary Outcome Measures :
  1. Individual semi-structured interviews about the experiences of Teenagers and Young Adults with Cancer undergoing OTC [ Time Frame: up to 60 min ]


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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830061


Sponsors and Collaborators
University of Oxford
Oxford University Hospitals NHS Trust
Investigators
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Principal Investigator: Rebekah Tennyson, DClinPsy Oxford Health NHS Foundation Trust

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02830061    
Other Study ID Numbers: 12019
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Keywords provided by University of Oxford:
Cancer
Teenage
Young Adult
Fertility
Cryopreservation
Experience