Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue (PACTT)
Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue (PACTT)
Cancer treatment can cause infertility. Fertility preservation is possible for many populations through, egg, sperm or ovarian tissue freezing prior to cancer treatment. However, there is no established technology to protect the fertility of pre-pubertal boys.
Outcomes: Primary outcome is to identify whether male (assigned male at birth) oncology survivors who had prior testicular tissue cryopreservation would be willing to undergo testicular tissue grafting. The secondary outcomes identify what factors influence decision for testicular grafting including demographics factors, fertility related knowledge, reproductive goals and concerns, unmet fertility needs, decisional conflict and regret about fertility care, patient reported outcome measures (stress and anxiety), attempted or actual parenthood or natural fertility restoration
Participants: 105 Male aged 18 years and over who completed oncology treatment at the Royal Children's Hospital (RCH) at least one year prior and had testicular tissue cryopreservation for fertility preservation.
Sites: Murdoch Children Research Institute (MCRI)
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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 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 COM-B (Capability, Opportunity, Motivation - Behaviour) model.
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Diana Navarro - Perez, PhD
- Telefonszám: 03 8345 3721
- E-mail: d.navarroperez@unimelb.edu.au
Tanulmányi helyek
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Victoria
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Parkville, Victoria, Ausztrália, 3052
- Murdoch Children's Research Institute
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Kapcsolatba lépni:
- Diana Navarro -Perez, PhD
- Telefonszám: 03 8345 3721
- E-mail: d.navarroperez@unimelb.edu.au
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Alkutató:
- Debra Gook, PhD, Senior Investigator
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Alkutató:
- Margaret Zacharin, MBBS, FRACP, PhD
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Alkutató:
- Michael Assis, PhD, Postdoc Research Fellow
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Alkutató:
- Hossam Elzeiny, MB ChB, AMC Certificate, FRANZ
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Alkutató:
- Zobaida Edib, PhD, Postdoc Research Fellow
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Alkutató:
- Apoorva Bhargava, MPH, Research Fellow
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Alkutató:
- Diana Navarro - Perez, PhD, MSc
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Participants are identified from the Melbourne Oncofertility Registry (MORE Registry) as patients who had testicular tissue cryopreservation at the Royal Children's Hospital as part of their cancer treatment.
Leírás
Inclusion Criteria:
- Assigned male at birth who have completed oncology treatment of childhood oncology treatment (they may have had malignant or benign disease)
- Who are 18 years and over
- Who had testicular tissue cryopreservation as part of their childhood oncology care
- Who have completed curative gonadotoxic treatment.
- Can communicate in English.
- Can provide a signed written informed consent
Exclusion Criteria:
- Deceased patients
- Patients currently undergoing active gonadotoxic cancer treatment.
- Patients who are palliative
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: COHORT
- Időperspektívák: PROSPECTIVE
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
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105 males aged 18 years and above who had testicular tissue cryopreservation at the RCH
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No intervention |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Willingness to consider testicular tissue grafting as measured by responses to a likert scale on the study survey
Időkeret: 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. |
Baseline
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Willingness to consider testicular tissue grafting within a specified time period (1 year) as measured by responses to a likert scale on the study survey
Időkeret: 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. |
Baseline
|
|
Willingness to consider testicular tissue grafting within a specified time period (5 year) as measured by responses to a likert scale on the study survey
Időkeret: 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. |
Baseline
|
|
Willingness to consider testicular tissue grafting within a specified time period (10 year) as measured by responses to a likert scale on the study survey
Időkeret: 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. |
Baseline
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Willingness to consider testicular tissue grafting according to perceived potential beneficial outcomes as measured by responses to a likert scale on the study survey
Időkeret: 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. |
Baseline
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Willingness to consider testicular tissue grafting according to perceived safety as measured by responses to a likert scale on the study survey
Időkeret: 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. |
Baseline
|
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Perceived social pressure from partners, parents, general practitioners (GP) and religious leaders as measured by responses to the Theory of Planned Behaviour questionnaire.
Időkeret: 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) |
Baseline
|
|
Perceived behavioural control as measured by responses to the Theory of Planned Behaviour questionnaire.
Időkeret: Baseline
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Responses to either disagree or agree. |
Baseline
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Unmet fertility information needs as measured by The Unmet Needs Survey (as used/adapted from Benedicts et al., 2023).
Időkeret: Baseline
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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. |
Baseline
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Decisional Conflict as measured by the Decisional Conflict Scale (DCS).
Időkeret: Baseline
|
The decisional conflict scale ranges between 0 to 100.Higher scores on the scale indicate greater decisional conflict. |
Baseline
|
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Cancer impact and information as measured by The Cancer Impact and Information Needs survey (as used by the AYA HOPE Study Collaborative Group - Harlan et al., 2011).
Időkeret: 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). |
Baseline
|
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Financial toxicity survey as measured by the Comprehensive Score for Financial Toxicity (COST).
Időkeret: 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. |
Baseline
|
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Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 6a
Időkeret: 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. |
Baseline
|
|
Depression as measured by PROMIS 6a
Időkeret: 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. |
Baseline
|
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Stress as measured by PROMIS 8a
Időkeret: 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. |
Baseline
|
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Optimism as measured by the adapted Life Orientation Scale.
Időkeret: Baseline
|
Optimism (Life Orientation) scale is used in the reduced form with only the optimistic measures (3-item 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. |
Baseline
|
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Medical Decision-Making preferences as measured by the Control Preferences Scale
Időkeret: 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. |
Baseline
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Reproductive Goals (as adapted from Lehmann et al., 2017).
Időkeret: Baseline
|
Reproductive goals are assessed using 5 items categorising responses between yes, no or unsure. |
Baseline
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Yasmin Jayasinghe, MBBS, FRANZCOG, PhD, University of Melbourne
Publikációk és hasznos linkek
Általános kiadványok
- Lehmann V, Keim MC, Nahata L, Shultz EL, Klosky JL, Tuinman MA, Gerhardt CA. Fertility-related knowledge and reproductive goals in childhood cancer survivors: short communication. Hum Reprod. 2017 Nov 1;32(11):2250-2253. doi: 10.1093/humrep/dex297.
- Benedict C, Stal J, Davis A, Zeidman A, Pons D, Schapira L, Diefenbach M, Ford JS. Greater fertility distress and avoidance relate to poorer decision making about family building after cancer among adolescent and young adult female survivors. Psychooncology. 2023 Oct;32(10):1606-1615. doi: 10.1002/pon.6212. Epub 2023 Sep 11.
- Harlan LC, Lynch CF, Keegan TH, Hamilton AS, Wu XC, Kato I, West MM, Cress RD, Schwartz SM, Smith AW, Deapen D, Stringer SM, Potosky AL; AYA HOPE Study Collaborative Group. Recruitment and follow-up of adolescent and young adult cancer survivors: the AYA HOPE Study. J Cancer Surviv. 2011 Sep;5(3):305-14. doi: 10.1007/s11764-011-0173-y. Epub 2011 Jan 28.
- Fayomi AP, Peters K, Sukhwani M, Valli-Pulaski H, Shetty G, Meistrich ML, Houser L, Robertson N, Roberts V, Ramsey C, Hanna C, Hennebold JD, Dobrinski I, Orwig KE. Autologous grafting of cryopreserved prepubertal rhesus testis produces sperm and offspring. Science. 2019 Mar 22;363(6433):1314-1319. doi: 10.1126/science.aav2914.
- Safrai M, Goossens E, Mitchell RT, Orwig KE, Mulder CL, van Pelt AMM, Gook DA, Feraille A, Delgouffe E, Ginsberg JP, Stukenborg JB, Duffin K, Jahnukainen K, Andersen CY, van de Wetering MD, Rimmer MP, Barraud-Lange V, Neuhaus N, Lane S, Sadri-Ardekani H, Rives N, Wyns C. Is the time right for transplanting immature testicular tissue or cells to restore male fertility? Expert perspectives on clinical implementation of autotransplantation of cryopreserved testicular tissue or cells for fertility restoration. Best Pract Res Clin Obstet Gynaecol. 2025 Sep;102:102638. doi: 10.1016/j.bpobgyn.2025.102638. Epub 2025 Jul 11.
- Khattak H, Malhas R, Craciunas L, Afifi Y, Amorim CA, Fishel S, Silber S, Gook D, Demeestere I, Bystrova O, Lisyanskaya A, Manikhas G, Lotz L, Dittrich R, Colmorn LB, Macklon KT, Hjorth IMD, Kristensen SG, Gallos I, Coomarasamy A. Correction to: Fresh and cryopreserved ovarian tissue transplantation for preserving reproductive and endocrine function: a systematic review and individual patient data meta-analysis. Hum Reprod Update. 2022 May 2;28(3):455. doi: 10.1093/humupd/dmac015. No abstract available.
- Rozen G, Sii S, Agresta F, Gook D, Polyakov A, Stern C. Ovarian tissue grafting: Lessons learnt from our experience with 55 grafts. Reprod Med Biol. 2021 May 12;20(3):277-288. doi: 10.1002/rmb2.12380. eCollection 2021 Jul.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- HREC 130619
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
De- identified individual participant data (IPD) will be shared with study collaborators upon request and as necessary to facilitate research collaborations and study publications.
Individual participant data that underlie the results reported after de-identification (text, tables, figures and appendices), participant information and consent form (PICF).
IPD megosztási időkeret
Following analysis and article publication.
IPD-megosztási hozzáférési feltételek
Only authorised study site staff will have access to de-identified information. De-identified IPD will be shared with collaborators only in specific circumstances where sharing the data will benefits and extend research collaborations.
Az IPD megosztását támogató információ típusa
- ICF
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
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