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Clinical Trial Details

A pilot study evaluating feasibility and acceptability of a psychosexual intervention for couples post-allogeneic haematopoietic stem cell transplantation

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Trial Information

Broad Health Condition Blood
Cancer
Cancer
Cancer
Cancer
Cancer
Cancer

Specific Health ConditionHaematological diseases
Hodgkin's
Leukaemia - Acute leukaemia
Leukaemia - Chronic leukaemia
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Myeloma

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne


Postcode
3000 - Melbourne

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

This pilot study aims to examine the feasibility and acceptability of implementing a psychosexual and relationship education intervention for allogeneic haematopoietic stem cell transplantation (HSCT) survivors and their partners post-transplantation.

Who is it for?
You may be eligible for this study if you are aged 18 or older, you have received an allogeneic haematopoietic stem cell transplantation to treat a haematological malignancy (blood cancer) more than 3 months ago, you are in a sexual relationship and would like to receive assistance for identified sexual health issues.

Study details
All participants and their partners who choose to enrol in this study will receive one 60 minute educational session about medical and behavioural treatment options for sexual dysfunction delivered by a haematology nurse consultant. Enrolled couples will then also receive four 90 minute Emotionally Focused Therapy (EFT)-based relationship education sessions delivered by a clinical psychologist. Couples will be asked to complete a series of questionnaires before receiving the intervention sessions, and again after the final intervention session, 

It is hoped this research will demonstrate that a psychosexual intervention combining medical/behavioural management of sexual dysfunction and relationship education sessions will be feasible and helpful for patients with blood cancers. This may be used to improve sexual health outcomes for these and future patients and their partners.
 
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 age18 Years

GenderBoth 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
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Peter MacCallum Cancer Centre
Primary Sponsor Address: 305 Grattan Street, Melbourne, VIC 3000
Primary Sponsor Country: Australia

Trial IDACTRN12620001220954

Contact person for information and recruitmentDr
Brindha Pillay
Psychosocial Oncology Program Peter MacCallum Cancer Centre 305 Grattan Street, Melbourne VIC 3000
+61 3 85595265

Further information iconbrindha.pillay@petermac.org
Australia