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Trial registered on ANZCTR


Registration number
ACTRN12615000399594
Ethics application status
Approved
Date submitted
1/04/2015
Date registered
29/04/2015
Date last updated
29/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized trial of a minimal psycho-educational intervention for sexual concerns after cancer: A comparison of self-help and professionally delivered modalities
Scientific title
A randomized trial of a minimal psycho-educational intervention for sexual concerns after cancer: A comparison of self-help and professionally delivered modalities
Secondary ID [1] 286450 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual functioning 294623 0
Psychological wellbeing 294624 0
Quality of life 294625 0
Condition category
Condition code
Cancer 294925 294925 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health professional intervention: minimal psycho-educational written information provision (self-help booklet) about cancer related sexual changes 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 sexuality. Concerns or questions raised as a result of reading the booklet were discussed during the consultation, and suggestions for ameliorating sexual problems, based on the specific needs of participants, were offered.
The self-help information booklet is based on accounts of sexual concerns experienced by people with cancer and their partners, consultation with health professionals, and examination of existing written resources on cancer related sexual concerns. It consisted of 68 pages, which provided information about: what is sexuality and intimacy; how cancer and cancer treatment affects sexuality; the body and sex; sexuality across different stages of cancer; talking about sex and intimacy; information for partners and for single people; same-sex relationships; strategies for overcoming sexual concerns, including exploration of non-coital practices and intimacy; and support services available.
Intervention code [1] 291528 0
Lifestyle
Intervention code [2] 291649 0
Behaviour
Comparator / control treatment
Self-help intervention: minimal psycho-educational written information provision about cancer related sexual changes. The self-help information booklet is based on accounts of sexual concerns experienced by people with cancer and their partners, consultation with health professionals, and examination of existing written resources on cancer related sexual concerns. It consisted of 68 pages, which provided information about: what is sexuality and intimacy; how cancer and cancer treatment affects sexuality; the body and sex; sexuality across different stages of cancer; talking about sex and intimacy; information for partners and for single people; same-sex relationships; strategies for overcoming sexual concerns, including exploration of non-coital practices and intimacy; and support services available.
Control group
Active

Outcomes
Primary outcome [1] 294681 0
Health related quality of life was measured with the Medical Outcomes Study Health Survey Short Form (SF-12)
Timepoint [1] 294681 0
Participants completed quantitative measures in a questionnaire pre-intervention at baseline, six weeks post-intervention and at three months follow-up.
Primary outcome [2] 294682 0
Psychological wellbeing was measured with the Hospital Anxiety and Depression Scale (HADS).
Timepoint [2] 294682 0
Participants completed quantitative measures in a questionnaire pre-intervention at baseline, six weeks post-intervention and at three months follow-up.
Primary outcome [3] 294683 0
Sexual function was measured with the Changes in Sexual Functioning Questionnaire (CSFQ-14).
Timepoint [3] 294683 0
Participants completed quantitative measures in a questionnaire pre-intervention at baseline, six weeks post-intervention and at three months follow-up.
Secondary outcome [1] 313860 0
Relationship satisfaction was measured with the Brief Dyadic Adjustment Scale (DAS).
Timepoint [1] 313860 0
Participants completed quantitative measures in a questionnaire pre-intervention at baseline, six weeks post-intervention and at three months follow-up.
Secondary outcome [2] 313861 0
Sexual communication was assessed with the Dyadic Sexual Communication Scale (DSCS).
Timepoint [2] 313861 0
Participants completed quantitative measures in a questionnaire pre-intervention at baseline, six weeks post-intervention and at three months follow-up.
Secondary outcome [3] 313862 0
Satisfaction with Sexual Relationship was assessed with a one-item measure that asked participants ‘how satisfied are you with your sexual relationship?’, on a 5-point Likert scale
Timepoint [3] 313862 0
Participants completed quantitative measures in a questionnaire pre-intervention at baseline, six weeks post-intervention and at three months follow-up.

Eligibility
Key inclusion criteria
Self-nominated person with cancer, or the partner of a person with cancer who had experienced cancer related sexual concerns.
Minimum age
18 Years
Maximum age
No limit
Gender
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 an intervention 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 a couple basis for those in a relationship, following previous suggestions that couple based interventions are most effective. However, in order to meet the needs of those who were single, or those who had partners who did not want to participate, the two interventions were also 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 for the detection of moderate clinical differences. Strata differentiated by cancer type, including both sexual and non-sexual cancers (prostrate/testicular; breast; gynaecological; other cancers).
Univariate analyses were conducted to compare participants in the two intervention conditions for each of the socio-demographic variables of interest separately for people with cancer (PWC) and partners of people with cancer (PPWC). For continuous variables, one-way ANOVA were conducted with intervention, participant type, or 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 and participate type. 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 sexual changes and communication about sexual 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 according to participant type. 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 follow-up as the within-subjects variables, with intervention condition (SH or HP), participant type (PWC or PPWC), gender (men or women) and cancer type (sexual or non-sexual) as the between-subjects factors. An alpha level of .05 was used for all statistical tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291018 0
Government body
Name [1] 291018 0
Australian Research Council
Address [1] 291018 0
GPO Box 2702. Canberra ACT 2601.
Country [1] 291018 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] 289695 0
Individual
Name [1] 289695 0
Professor Janette Perz
Address [1] 289695 0
Centre for Health Research
School of Medicine
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country [1] 289695 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292601 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 292601 0
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 292601 0
Australia
Date submitted for ethics approval [1] 292601 0
Approval date [1] 292601 0
30/10/2008
Ethics approval number [1] 292601 0
H6545

Summary
Brief summary
Sexuality and intimacy are key aspects 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, and little is known about the factors which predict difficulties or re-negotiation of sexuality post-cancer This study will examine the experience and construction of intimacy and sexuality 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, programs of targeted couple interventions will be developed, and evaluated in a randomised controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56170 0
Prof Jane Ussher
Address 56170 0
Centre for Health Research, School of Medicine
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country 56170 0
Australia
Phone 56170 0
+61246203953
Fax 56170 0
Email 56170 0
j.ussher@uws.edu.au
Contact person for public queries
Name 56171 0
Prof Jane Ussher
Address 56171 0
Centre for Health Research, School of Medicine
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country 56171 0
Australia
Phone 56171 0
+61246203953
Fax 56171 0
Email 56171 0
j.ussher@uws.edu.au
Contact person for scientific queries
Name 56172 0
Prof Jane Ussher
Address 56172 0
Centre for Health Research, School of Medicine
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country 56172 0
Australia
Phone 56172 0
+61246203953
Fax 56172 0
Email 56172 0
j.ussher@uws.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary