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Trial registered on ANZCTR


Registration number
ACTRN12620001220954
Ethics application status
Approved
Date submitted
12/09/2020
Date registered
16/11/2020
Date last updated
16/11/2020
Date data sharing statement initially provided
16/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study evaluating feasibility and acceptability of a psychosexual intervention for couples post-allogeneic haematopoietic stem cell transplantation
Scientific title
A pilot study evaluating feasibility and acceptability of a psychosexual intervention for couples post-allogeneic haematopoietic stem cell transplantation
Secondary ID [1] 302290 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual dysfunction post-allogeneic haematopoietic stem cell treatment 319033 0
haemtological cancers 319364 0
haematological malignancies 319365 0
Condition category
Condition code
Blood 316987 316987 0 0
Haematological diseases
Cancer 317322 317322 0 0
Hodgkin's
Cancer 317323 317323 0 0
Leukaemia - Acute leukaemia
Cancer 317324 317324 0 0
Leukaemia - Chronic leukaemia
Cancer 317325 317325 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 317326 317326 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 317327 317327 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention
The pilot intervention will comprise two components:
1) Psychosexual education about medical and behavioural treatment options for sexual dysfunction
2) EFT-based relationship education program for couples
Psychosexual Education
A 60-minute individual psychosexual education session will be delivered to couple participants by a specialist nurse. This session will include information about medical and behavioural management of sexual dysfunction (including the use of hormone treatment, topical treatments, lubricants and vaginal dilators for women, and PDE5 inhibitors). The session will be delivered using the PLISSIT model (i.e., Permission, Limited information, Specific Suggestions and Intensive Therapy model).

Emotionally Focused Therapy (EFT) -based relationship education program for couples

The couples’ relationship education program will comprise four 90-minute sessions and be delivered fortnightly over 8 weeks to each couple by a clinical psychologist. It will use an EFT framework, aimed to assist couples in building and enhancing the attachment bond to improve the quality of their relationship and enhance sexual intimacy. The intervention material was adapted from three EFT resources developed for couples (listed below), and modified to make it relevant to the HSCT population.

In Session 1, the goal will be to establish an alliance with the couple, to introduce the program and to allow each of them the opportunity to talk about the different ways that cancer and the HSCT has affected their relationship.

Session 2 will focus on identifying negative interactional cycles and attachment vulnerabilities within the dyad that trigger such interactional patterns. The session will help couples to access underlying emotions supporting the reactive moves in the cycle and then reframe the problem in terms of the negative cycle (rather than each other). The couples will also be taken through an explanation about different types of vulnerable emotions that can trigger negative interactions as well as ways to communicate more effectively.

Session 3 will assist the couple in sharing fears and needs with each other in a manner that helps their partners respond to them. This will facilitate the deeper expression of attachment emotions and needs, creating more open emotional engagement within the couple. In addition, psychoeducation regarding the impact of cancer and HSCT on the sexual relationship will be provided.

Session 4 will aim to elicit discussion about the couple’s sexual relationship, including previously formed perceptions of self, other and the relationship, and how this can be related to sexual intimacy. Other topics of discussion will include adopting a flexible view of sexual intimacy after disease and treatment stressors and practical ways to continue to nurture the relationship moving forward. Finally, an overview of sessions will be provided. This EFT intervention aims to equip couples with skills to establish a more secure bond and create new positive interactions within the dyad, in the context of living with a haematological cancer and undergoing an intense treatment.

Participants will be provided with written information to support the interventions sessions. The information was adapted from “Hold Me Tight: Conversations for Connection” by Sue Johnson and “Healing Hearts Together Relationship Education Program” by Dr Heather Tulloch, Dr Paul Greenman, Dr Natasha Demidenko, and Dr Sue Johnson and “An Emotionally Focused Workbook for Couples: The two of us” by Veronica Kallos-Lilly and Jennifer Fitzgerald.

A Case Report Form will be used by the project team to assess referral rates into the study, uptake of the intervention and patient adherence to the intervention. In particular, data will be collected regarding number of patients who were referred to the study, those that refused intervention despite meeting eligibility criteria, and number of intervention sessions completed. The clinician administering the treatment will also complete a session checklist after each session.


Intervention code [1] 318795 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325097 0
Sexual function
International Index of Erectile Functioning (IIEF)
Female Sexual Function Index (FSFI)
Timepoint [1] 325097 0
Baseline (pre-intervention) and 2 weeks post-completion of the intervention.
Primary outcome [2] 325098 0
Relationship quality:
Perceived Relationship Quality Components Inventory (PRQC)
Timepoint [2] 325098 0
The PRQC will be administered at baseline (pre-intervention) and 2 weeks post-completion of intervention.
Primary outcome [3] 325099 0
Patient and partner satisfaction with intervention will be assessed using study-specific questionnaires.
Timepoint [3] 325099 0
Following each of the 4 sessions of the psychological intervention component, and 2 weeks post-completion of the intervention
Secondary outcome [1] 386838 0
Fidelity of the intervention will be assessed through 1) a review of each of the 5 sessions using session checklists to ascertain if all relevant topics were discussed 2) recording all sessions and then reviewing 10% of therapy sessions to check compliance with protocols.
Timepoint [1] 386838 0
After each session of the intervention (5 sessions in total)
Secondary outcome [2] 387694 0
Feasibility will be measured by calculating enrolment rate for eligible patients and the adherence rate to the intervention.

Specifically, feasibility criteria are:
At least 39% of eligible patients (and their partners) will be enrolled.

At least 67% of patients (and their partners) enrolled in the study will attend 4 intervention sessions.
Timepoint [2] 387694 0
At completion of the intervention (after 5 sessions or at point of patient withdrawal from intervention)
Secondary outcome [3] 387695 0
General Anxiety Disorder-7 (GAD-7)
Timepoint [3] 387695 0
Baseline (Pre-intervention) and 2 weeks post-completion of intervention
Secondary outcome [4] 387696 0
Patient Health Questionnaire-9 (PHQ 9)
Timepoint [4] 387696 0
Baseline (pre-intervention) and 2 weeks post-completion of intervention

Eligibility
Key inclusion criteria
- Age: At least 18 years of age (both patient and partner)
- More than 3 months post-haematopoietic transplantation to treat a haematological malignancy
- Patient has not relapsed since transplant
- In a sexual relationship (same sex couples included) of at least 1 year (as reported by the patient) but couples do not need to be currently sexually active to participate in the study
- Able to give informed consent (i.e. no psychiatric/cognitive condition that would impact informed consent, as based on clinical judgment)
- Patient states that they have sexual health problems and would like help with these issues
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently receiving couples counselling from a therapist not involved in the study;
- Partner is not willing to participate in the intervention
- Patient has had a relapse of disease and/or has been readmitted to hospital
- Patient is suffering from significant ongoing side effects that might impede their participation

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic, clinical and feasibility data (including time measures) and survey responses will be analysed descriptively (count/percentage, mean/standard deviation, median/interquartile range as appropriate). Patient- and partner-reported outcomes will be scored according to their manuals, and will be presented descriptively. One measure, the Experiences in Close Relationship Scale (short form) will be administered only pre-intervention to inform delivery of the intervention.

Preliminary analyses comparing pre- and post-intervention outcomes will be conducted using paired t-tests. Feasibility criteria (and data collected will be based on previous studies. The Patient/Partner Satisfaction Surveys will also be used to assess the impact of the intervention and its feasibility, by reporting frequency data for each item.

Data will be managed through REDCap and quantitative data will be analysed using SPSS (version 24). Free text items from the patient satisfaction surveys will be analysed using summarising content analysis using NVivo software. A deductive content analysis approach will be used for coding data. Pre-defined categories will be formulated based on the research questions informing the study. Additional inductive codes will be identified from the survey responses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2020
Date of last participant enrolment
Anticipated
1/06/2021
Actual
Date of last data collection
Anticipated
1/09/2021
Actual
Sample size
Target
15
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17517 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 31247 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 306716 0
Hospital
Name [1] 306716 0
Peter MacCallum Cancer Centre
Country [1] 306716 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street, Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 307264 0
None
Name [1] 307264 0
Address [1] 307264 0
Country [1] 307264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306886 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 306886 0
Ethics committee country [1] 306886 0
Australia
Date submitted for ethics approval [1] 306886 0
25/03/2019
Approval date [1] 306886 0
25/06/2019
Ethics approval number [1] 306886 0
HREC/53351/PMCC-2019; Project number: 19/54

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105346 0
Dr Brindha Pillay
Address 105346 0
Psychosocial Oncology Program
Peter MacCallum Cancer Centre
305 Grattan Street,
Melbourne
VIC 3000
Country 105346 0
Australia
Phone 105346 0
+61 3 85595265
Fax 105346 0
Email 105346 0
brindha.pillay@petermac.org
Contact person for public queries
Name 105347 0
Brindha Pillay
Address 105347 0
Psychosocial Oncology Program
Peter MacCallum Cancer Centre
305 Grattan Street,
Melbourne
VIC 3000
Country 105347 0
Australia
Phone 105347 0
+61 3 85595265
Fax 105347 0
Email 105347 0
brindha.pillay@petermac.org
Contact person for scientific queries
Name 105348 0
Brindha Pillay
Address 105348 0
Psychosocial Oncology Program
Peter MacCallum Cancer Centre
305 Grattan Street,
Melbourne
VIC 3000
Country 105348 0
Australia
Phone 105348 0
+61 3 85595265
Fax 105348 0
Email 105348 0
brindha.pillay@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.