Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue

Cancer treatment can cause infertility. Fertility preservation is possible for many populations through egg, sperm or ovarian tissue freezing prior to cancer treatment. There is no established technology to protect the fertility of prepubertal boys. Many centres internationally, including the Royal Children's Hospital, have offered freezing of testis tissue as a new technology, in the hope that technology will develop to be able to mature the tissue into sperm so that it can be used for parenthood. In animals, grafting of the testis tissue back into the body has resulted in successful births. This has paved the way for testicular tissue grafting in humans as a novel technology. The primary aim of this study is to identify whether male (assigned male at birth) patients who have completed oncology treatment who had prior testicular tissue cryopreservation would be willing to undergo testicular tissue grafting. Predictive factors and barriers will also be assessed. We will ask participants to complete a survey which will take 15 minutes. Participants will be reimbursed for their time. They will be referred to reproductive counsellors if participation causes emotional discomfort or distress

Study Question: What are the factors influencing intention to autograft previously stored cryopreserved testicular tissue for the purposes of fertility restoration?

Study Objectives: To identify barriers, enablers and facilitators for testicular tissue grafting in adult who have completed oncology treatment who had previously undergone testicular tissue cryopreservation in childhood.

Primary Objective: To identify whether patients who have completed oncology treatment who had testicular tissue cryopreservation would be willing to undergo testicular tissue grafting.

Secondary Objective: to identify what factors influence decisions for testicular tissue grafting including demographic factors, fertility-related knowledge, reproductive goals and concerns, unmet fertility needs, decisional conflict patient reported outcome measures (stress and anxiety), attempted or actual parenthood or natural fertility restoration.

Design: Cross-sectional survey of patients who have completed oncology treatment who had prior testicular tissue cryopreservation at The Royal Children's Hospital (RCH) as part of their oncology treatment. Validated and purposively designed surveys (by clinician scientists) and utilised in previous studies of Adolescent and Young Adult (AYA) Oncofertility will identify barriers and enablers. Qualitative data will be grouped according to The Theory of Planned Behaviour and the Capability, Opportunity, Motivation - Behaviour (COM-B) model.

No informado en este registro.

Other: No intervention

No intervention

Plazo: Baseline

Willingness to undergo testicular tissue grafting as measured by the likert scale will range from 1 (strongly agree) to 7 (strongly disagree). Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.

Plazo: Baseline

Willingness to undergo testicular tissue grafting as measured by the likert scale will range from 1 (strongly agree) to 7 (strongly disagree). Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.

Plazo: Baseline

Willingness to undergo testicular tissue grafting as measured by the likert scale will range from 1 (strongly agree) to 7 (strongly disagree). Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.

Plazo: Baseline

Willingness to undergo testicular tissue grafting as measured by the likert scale will range from 1 (strongly agree) to 7 (strongly disagree). Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.

Plazo: Baseline

Willingness to undergo testicular tissue grafting in the hope that it will contribute to \[parenthood as soon as possible\] \[mature sperm that can be frozen\] \[improved guidelines for testicular grafting\].

Responses from 1 strongly agree to 7 strongly disagree. Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.

Plazo: Baseline

Willingness to undergo testicular tissue grafting because it is \[safe\] \[acceptable\] \[within my right to do so\] responses as percentages 0, 1, 5, 10, 20% or more.

Responses from 1 strongly agree to 7 strongly disagree. Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing); or agree/disagree.

Plazo: Baseline

Responses from 1 strongly agree to 7 strongly disagree. Responses will be assessed where 4 will be designated neutral. Survey responses will be dichotomised (\<4 = not willing and \>4 = willing)

Plazo: Baseline

Responses to either disagree or agree.

Plazo: Baseline

Unmet fertility information needs is assessed on a 6-point scale, ranging from 0 to 5, higher scores indicate greater unmet information needs. Unmet fertility information needs will be summarised as a mean score.

Plazo: Baseline

The decisional conflict scale ranges between 0 to 100.Higher scores on the scale indicate greater decisional conflict.

Plazo: Baseline

Assess opportunity of making a decision measured by cancer impact and information needs. Cancer impact and information needs are assessed on a 6 point Likert scale (1 = Very negative impact and 6 = Does not apply).

Plazo: Baseline

Financial toxicity scale is evaluated using an 11 items survey where scores range from 0 to 44 with lower scores indicating a higher cancer-related financial impact.

Plazo: Baseline

PROMIS anxiety is assessed using their short form with 6 items (PROMIS 6a) items in a 5 Likert scale (1 = never and 5 = always) raw scores are transformed using PROMIS T-score tables, higher T score means worse health.

Plazo: Baseline

PROMIS depression is assessed using their short form with 6 items (PROMIS 6a) items in a 5 Likert scale (1 = never and 5 = always) raw scores are transformed using PROMIS T-score tables, higher T score means worse health.

Plazo: Baseline

PROMIS stress is assessed using its short form (PROMIS 8a) 8 items in a 5 Likert scale (1 = never and 5 = always) raw scores are transformed using PROMIS T-score tables, higher T score means worse health.

Plazo: Baseline

Optimism (Life Orientation) scale is used in the reduced form with only the optimistic measures (3-item Life Orientation Test-Revised (LOT-R) optimism subscale) with responses assessed in a 5-point Likert scale ranging from 1 = strongly disagree and 5 = strongly agree, higher scores indicate higher dispositional optimism.

Plazo: Baseline

Medical Decision-Making preference is evaluated following the Control Preference Scale, where 5 items are ranked from the most preferred to the least preferred option, the highest rank item will determine if the chosen role is active, passive or collaborative.

Plazo: Baseline

Reproductive goals are assessed using 5 items categorising responses between yes, no or unsure.

Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue (PACTT)