Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000624583
Ethics application status
Approved
Date submitted
26/05/2015
Date registered
16/06/2015
Date last updated
16/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The construction and experience of fertility in the context of cancer: Patient, partner and health professional perspectives.
Scientific title
The construction and experience of fertility in the context of cancer: Evaluation of the effect of a self-help booklet combined with a health professional consultation versus the self-help booklet alone on quality of life in cancer patients
Secondary ID [1] 286716 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fertility
 295077 0
Psychological wellbeing 295233 0
Quality of life 295234 0
Cancer 295235 0
Condition category
Condition code
Cancer 295328 295328 0 0
Any cancer
Reproductive Health and Childbirth 295479 295479 0 0
Fertility including in vitro fertilisation
Mental Health 295480 295480 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health professional intervention: minimal psycho-educational written information provision (self-help booklet) about fertility and cancer accompanied by a single session of counselling.
The health professional consultation consisted of the self-help booklet followed up two weeks later by a one-hour telephone or Skype consultation between the participant and a counsellor trained in discussing fertility. Concerns or questions raised as a result of reading the booklet were discussed during the consultation, and suggestions for ameliorating fertility problems, based on the specific needs of participants, were offered.
The self-help information booklet is based on accounts of fertility concerns experienced by people with cancer and their partners, consultation with health professionals, and examination of existing written resources on cancer and fertility. It consisted of 84 pages, which provided information about:reproduction and fertility, key questions, talking about fertility, Women's fertility and cancer treatment, women's options before cancer treatment, women's options after cancer treatment, men's fertility and cancer treatment, Men's options before cancer treatment, men's options after cancer treatment, assessing your fertility, preserving fertility in childern and adolescents, other paths to parenthood, being child free, the emotional impact, relatioships and sexuality, making will informed decisions, questions for reflection, and support services available.
Intervention code [1] 291872 0
Lifestyle
Intervention code [2] 291873 0
Behaviour
Comparator / control treatment
Self-help intervention: minimal psycho-educational written information provision (self-help booklet) about fertility and cancer. The self-help information booklet is based on accounts of fertility concerns experienced by people with cancer and their partners, consultation with health professionals, and examination of existing written resources on cancer and fertility. It consisted of 84 pages, which provided information about:reproduction and fertility, key questions, talking about fertility, Women's fertility and cancer treatment, women's options before cancer treatment, women's options after cancer treatment, men's fertility and cancer treatment, Men's options before cancer treatment, men's options after cancer treatment, assessing your fertility, preserving fertility in childern and adolescents, other paths to parenthood, being child free, the emotional impact, relatioships and sexuality, making will informed decisions, questions for reflection, and support services available.
Control group
Active

Outcomes
Primary outcome [1] 295072 0
Health related quality of life was measured with the Medical Outcomes Health Survey Short Form (SF-12)
Timepoint [1] 295072 0
Participants completed quantitative measures in a questionnaire preintervention at baseline and at six weeks post-intervention.
Primary outcome [2] 295073 0
Distress thermometer
Timepoint [2] 295073 0
Participants completed quantitative measures in a questionnaire preintervention at baseline and at six weeks post-intervention.
Secondary outcome [1] 314708 0
14 item Health literacy scale (HLS-14) this is a validated tool.
Timepoint [1] 314708 0
Participants completed quantitative measures in a questionnaire preintervention at baseline and at six weeks post-intervention.
Secondary outcome [2] 315056 0
Program usefulness was assessed by a questionnaire designed specifically for this study
Timepoint [2] 315056 0
Participants completed qualitativie measures in a questionnaire at six weeks post-intervention.

Eligibility
Key inclusion criteria
Self-nominated person with cancer, or the partner of a person with cancer who had experienced fertility concerns.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None applied. No restrictions according cancer type, stage, treatments, time since diagnosis.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
In response to a study invitation, participants indicated whether they would like to be considered to take part in the evaluation of anintervention providing information about cancer related sexual changes. Those who agreed to take part were then randomly allocated to one of two conditions: self-help information only (SH), or information plus health
professional consultation (HP). Randomization was stratified according to gender and cancer classification.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-toss.
Allocation was not concealed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The SH and HP interventions were offered on an individual basis.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using stratified random sampling of participants in Stage one (survey) of the of the ARC project who agree to take part in stage three (intervention), 160 participants, respectively (proportionally allocated per cancer type stratum) were allocated to each condition. Based upon 0.8 power calculations using a significance level of 0.01 to adjust for multiple comparisons, a sample size of 80 per condition is sufficient to allow forthe detection of moderate clinical differences. Strata differentiated by cancer type, including both reporductive and non-reproductive cancers.
Univariate analyses were conducted to compare participants in the two intervention conditions for each of the socio-demographic variables of interest. For continuous variables, one-way ANOVA were conducted with intervention, gender used as the grouping variable, and the chi square test for independence used for frequency data. Descriptive frequency analyses were used to examine baseline/follow-up retention rates across intervention conditions. Descriptive analyses examined program evaluation measures. To allow for dichotomous analysis and facilitate interpretation,
ratings of program usefulness were recoded into ‘not useful’ and ‘useful(a little > extremely)’, reflecting the direction and meaning of the original Likert scales. The Fisher’s Exact Test (FET) was performed upon the categorical data associated with the perceived usefulness of the booklet in managing fertility changes across the SH and HP intervention conditions. In these analyses, the FET calculates the exact probability of significant differences in the reported assignments of participants in the two intervention conditions. Independent sample t-tests were performed on outcome variables to assess baseline differences between the SH and HP intervention conditions. A series of separate mixed repeated measures ANOVA were conducted on scores on each outcome variable across the three time conditions, pre-test, post-test and followup as the within-subjects variables, with intervention condition (SH or
HP), gender (men or women) and cancer type (reproductive or non-reproductive) as the between-subjects factors. An
alpha level of .05 was used for all statistical tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2014
Actual
9/08/2014
Date of last participant enrolment
Anticipated
1/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291277 0
Government body
Name [1] 291277 0
Australian Research Council
Country [1] 291277 0
Australia
Primary sponsor type
Individual
Name
Professor Jane Ussher
Address
Centre for Health Research
School of Medicine
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 289966 0
Individual
Name [1] 289966 0
Janette Perz
Address [1] 289966 0
Centre for Health Research
School of Medicine
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country [1] 289966 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292854 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 292854 0
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 292854 0
Albania
Date submitted for ethics approval [1] 292854 0
Approval date [1] 292854 0
08/12/2011
Ethics approval number [1] 292854 0
H9360

Summary
Brief summary
Fertility is a key aspect of quality of life detrimentally affected by cancer, resulting in significant reductions in well-being for people with cancer and their partners. However, health professionals rarely address this important health problem. This study will examine the experience and construction of fertility post-cancer, from the perspective of people with cancer, their partners, and health professionals, and elucidate pathways to difficulty or re-negotiation. Based on these findings, interventions will be developed, and evaluated in a randomised controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57210 0
Prof Jane Ussher
Address 57210 0
Centre for Health Research, School of Medicine University of Western Sydney Locked Bag 1797 Penrith NSW 2751
Country 57210 0
Australia
Phone 57210 0
+61246203953
Fax 57210 0
Email 57210 0
[email protected]
Contact person for public queries
Name 57211 0
Jane Ussher
Address 57211 0
Centre for Health Research, School of Medicine University of Western Sydney Locked Bag 1797 Penrith NSW 2751
Country 57211 0
Australia
Phone 57211 0
+61246203953
Fax 57211 0
Email 57211 0
[email protected]
Contact person for scientific queries
Name 57212 0
Jane Ussher
Address 57212 0
Centre for Health Research, School of Medicine University of Western Sydney Locked Bag 1797 Penrith NSW 2751
Country 57212 0
Australia
Phone 57212 0
+61246203953
Fax 57212 0
Email 57212 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized controlled evaluation of an educational resource to address fertility concerns after cancer.2021https://dx.doi.org/10.1002/pon.5703
EmbaseEvaluating Maybe Later Baby, a Fertility Information Resource for Adolescents and Young Adults Diagnosed with Cancer: A Randomized, Controlled Pilot Study.2023https://dx.doi.org/10.1089/jayao.2021.0206
N.B. These documents automatically identified may not have been verified by the study sponsor.