NCT02830061

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Status
completed

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

July 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

July 8, 2016

Last Update Submit

October 22, 2019

Conditions

Keywords

CancerTeenageYoung AdultFertilityCryopreservationExperience

Outcome Measures

Primary Outcomes (1)

  • Individual semi-structured interviews about the experiences of Teenagers and Young Adults with Cancer undergoing OTC

    up to 60 min

Study Arms (1)

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

Interventions

Individual semi-structured interviews for 30-60 minutes using an interview schedule developed from an interpretative phenomenological analysis framework.

TYAC

Eligibility Criteria

Age13 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Rebekah Tennyson, DClinPsy

    Oxford Health NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 12, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

October 24, 2019

Record last verified: 2019-10