Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001192572
Ethics application status
Approved
Date submitted
28/10/2015
Date registered
4/11/2015
Date last updated
4/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fertility Understanding Through Registry and Evaluation (FUTuRE Fertility): exploring the fertility-related quality of life and psychological distress in young people with cancer, their parents and aged matched controls.
Scientific title
To explore the psychosocial function, fertility related quality of life, and the meaning of parenthood in young people with and without cancer as well as parents of cancer patients: A prospective study.
Secondary ID [1] 287743 0
NIL
Universal Trial Number (UTN)
Trial acronym
FUTuRE Fertility Psychological Health study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fertility-related distress 296610 0
Fertility-related grief 296662 0
Fertility-related sadness 296663 0
Fertility-related depression 296664 0
Fertility-related anger 296665 0
Fertility-related disappointment 296666 0
Condition category
Condition code
Mental Health 296849 296849 0 0
Depression
Cancer 296850 296850 0 0
Any cancer
Reproductive Health and Childbirth 296886 296886 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cancer survivors who are actively trying to have a baby or who have been referred for fertility preservation (FP)/Assisted Reproductive Technologies (ART) will be recruited from the Australasian Oncofertility Registry (AOFR). Cancer patients will be asked to complete one questionnaire and two sixty-minute semi-structured telephone interviews with the FUTuRE Fertility study clinical psychologist, at three different time points (diagnosis, 12 months and 3 years post treatment). The questionnaire will be used to collect information on cancer diagnosis and treatment, time from cancer treatment, fertility preservation and treatment before or after cancer treatment as well as collecting information on the psychological distress experienced by patients who are rendered infertile as a direct result of their cancer treatment. The patients will be matched to non-cancer control participants by age group and sex who have experienced infertility for other reasons unrelated to cancer. Parents of cancer patients will also be asked to complete one questionnaire a three different time points (diagnosis, 12 months and 3 years post treatment) as well as two sixty-minute semi-structured telephone interviews with the FUTuRE Fertility Study Clinical Psychologist to: (i) determine the challenges of fertility preservation that parents of cancer patients aged 15-25 years’ experience; (ii) compare the differences in fertility related quality of life that parents of cancer patients aged 15-25 years whom have had a fertility preservation consultation and possible fertility preservation procedures experience compared to those parents whose child either did not have an opportunity for consultation or fertility preservation procedures; (iii) explore the fertility related psychological distress faced by parents of cancer patients aged 15-25 year old at different time points.
Intervention code [1] 293140 0
Not applicable
Comparator / control treatment
The aged matched controls will comprise of 15-25 year olds, who have not been diagnosed with cancer and consent to participate on the study will be recruited to participate on the research study in order to compare their fertility related quality of life and psychological issues prior to starting a family. Aged matched controls will be important to recruit as the research group are interested in comparing the cancer experience of 15-25 year old patients with the thoughts and feelings of aged matched controls (for example experiences associated with future parenthood, dating, relationships, sexuality, reproductive health). The duration of the follow-up period for this group, where a questionnaire will be administered and two sixty minute semi structured interviews will be conducted will be at: enrolment, 12 months and 3 years

The control group will consist of male and female non-cancer patients who have or are having a consultation with a fertility specialist with the intention of trying to conceive a baby or looking for options of having a family such as using donor egg or sperm as a result of infertility that is not related to a cancer diagnosis. These patients may have proven infertility from a number of causes such as polycystic ovarian syndrome, primary ovarian insufficiency, endometriosis, autoimmune disease, hormonal insufficiency, and structural abnormalities in male and female gonadal tissue and azoospermia.
Control group
Active

Outcomes
Primary outcome [1] 296459 0
To prospectively explore the short-term fertility concerns that cancer patients aged 15-25 years and their families have (medical, psychological and practical). Outcomes will be assessed from the questionnaire and semi-structure phone interview specifically designed for this study.
Timepoint [1] 296459 0
12 months
Secondary outcome [1] 318492 0
To document the fertility related quality of life and psychological distress of cancer patients aged 15-25 years prior to starting a family compared to age matched controls. Outcomes will be assessed from the questionnaire and semi-structure phone interview specifically designed for this study.
Timepoint [1] 318492 0
Diagnosis (baseline)
Secondary outcome [2] 318591 0
To prospectively explore the long-term fertility concerns that cancer patients aged 15-25 years and their families have (medical, psychological and practical). Outcomes will be assessed from the questionnaire and semi-structure phone interview specifically designed for this study.
Timepoint [2] 318591 0
3 years
Secondary outcome [3] 318594 0
To document the fertility related quality of life and psychological distress of cancer patients aged 15-25 years prior to starting a family compared to age matched controls. Outcomes will be assessed from the questionnaire and semi-structure phone interview specifically designed for this study.
Timepoint [3] 318594 0
12 months
Secondary outcome [4] 318595 0
To document the fertility related quality of life and psychological distress of cancer patients aged 15-25 years prior to starting a family compared to age matched controls. Outcomes will be assessed from the questionnaire and semi-structure phone interview specifically designed for this study.
Timepoint [4] 318595 0
3 years

Eligibility
Key inclusion criteria
*Patients who consent to participate in the research study and are enrolled on the Australasian Oncofertility Registry
*Parents or carers who have a child with cancer enrolled on the Australasian Oncofertility Registry
*Aged matched controls aged 15-25 years who consent to participate on the research study

For inclusion in this study, patients will be aged 15-25 years, who have agreed to have their data stored on the Australasian Oncofertility Registry and have ticked on their consent form that they wish to participate in future studies and are happy to be contacted to participate on the FUTuRE Fertility Psychological Health Research study. Patients eligible to participate will be enrolled on the registry from between 0-90 days from their cancer diagnosis. Partners/parents/carers of a participant in the cancer group will also be contacted separately to say that their child/partner has agreed to participate in this study and will offer them the opportunity at this stage, via letter to the parent/partner/carer, by the FUTuRE Fertility Clinical Psychologist, to participate in this study.

Controls aged 15-25 years will be recruited via social media as well as from participating fertility sites enrolled on the Australasian Oncofertility Registry, to which ethics approval has been received for this study. The controls maybe visiting their fertility specialist for a number of different medical conditions such as: ovulation disorders (polycystic ovaries), uterine or cervical abnormalities, including problems with the opening of the cervix or cervical mucus, or abnormalities in the shape or cavity of the uterus (uterine fibroids), endometriosis, primary ovarian insufficiency, thyroid problems, abnormal sperm production or function due to various problems, such as undescended testicles, prior infections , trauma or prior surgeries on the testicles,

Both male and female non-cancer consenting participants aged 15-25 years will be matched by 5 year age-periods and gender to consenting cancer survivors who are actively trying to have a family.

Once a patient, parent or partner, matched control consents to participate, they will be contacted by either the study psychologist or a member of the research team who will explain the research study in detail in order to verify the participant's willingness to participate. An interpreter will be made available if required by the hospital, at a cost incurred by the FUTuRE Fertility research steering group. It will also be explained to the participant that if at any stage of the research study (questionnaire/telephone interview) that a participant decides to decline or stop participation with either the questionnaire or telephone interview, they will be able to do so immediately without any repercussions.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Patients who do not consent to participate in the research study
*Parents or carers who do not have a child with cancer enrolled on the Australasian Oncofertility Registry
*Aged matched controls aged 15-25 years who do not consent to participate on the research study who have or have previously had a cancer

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/10/2015
Date of last participant enrolment
Anticipated
30/11/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292286 0
Other Collaborative groups
Name [1] 292286 0
Australian and New Zealand Children's Haematology/Oncology Group
Country [1] 292286 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Prince of Wales Foundation Grant
Address
The Prince of Wales Foundation
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 290971 0
None
Name [1] 290971 0
None
Address [1] 290971 0
None
Country [1] 290971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293759 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 293759 0
Research Support Office
G71 East Wing, Edmund Blacket Building
Prince of Wales Hospital
High Street, Randwick NSW 2031
Ethics committee country [1] 293759 0
Australia
Date submitted for ethics approval [1] 293759 0
20/10/2015
Approval date [1] 293759 0
28/10/2015
Ethics approval number [1] 293759 0
AU/1/D03E114

Summary
Brief summary
The primary purpose of this study is to examine the fertility-related quality of life and psychological distress in young cancer patients and their parents/carers compared to individuals of the same age receiving a fertility consultation for fertility problems which are not related to cancer. Who is it for? You may be eligible to participate in this study if you are aged 15-25 and have been diagnosed with any cancer in the previous [0-90 days from diagnosis], or are receiving a fertility consultation for fertility problems which are not related to cancer. Parents/carers/partners of enrolled cancer patients may also participate. Study details: Cancer patients and non-cancer related fertility problem groups will complete one questionnaire at enrolment into the study, and then the same questionnaire at 12 months and three years’ post-treatment. Participants will also complete two sixty-minute semi-structured telephone calls at the enrolment, 12 months and 3 year time points. Parents/partners of cancer patients will complete one questionnaire and two-sixty minute semi-structured telephone interviews at three different time points which will include: at the patient’s cancer diagnosis, 12 months and three years post-treatment. All participants will be asked about their quality of life and psychological distress related to their infertility or their child's/partner’s infertility. Researchers will use the data collected from questionnaires and interviews to investigate the short and long term effects on mental health, quality of life and meaning of parenthood in these young adults. It is hoped that the findings of this study will inform healthcare providers of the psychological effects of cancer-related infertility in young people.
Trial website
www.futurefertility.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61210 0
Dr Antoinette Anazodo
Address 61210 0
Kids Cancer Centre
Sydney Children Hospital
High Street
Randwick NSW 2031
Country 61210 0
Australia
Phone 61210 0
+61447 017 444
Fax 61210 0
+612 9382 1789
Email 61210 0
[email protected]
Contact person for public queries
Name 61211 0
Ms Brigitte Gerstl
Address 61211 0
Kids Cancer Centre
Sydney Children Hospital
High Street
Randwick NSW 2031
Country 61211 0
Australia
Phone 61211 0
+61 404 082 190
Fax 61211 0
+612 9382 1789
Email 61211 0
[email protected]
Contact person for scientific queries
Name 61212 0
Dr Antoinette Anazodo
Address 61212 0
Kids Cancer Centre
Sydney Children Hospital
High Street
Randwick NSW 2031
Country 61212 0
Australia
Phone 61212 0
+61 447 017 444
Fax 61212 0
+612 9382 1789
Email 61212 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23398Study protocol  [email protected]
23399Statistical analysis plan  [email protected]
23400Informed consent form  [email protected]
23401Ethical approval  [email protected]

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.