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

Not Applicable

Recruiting

• Conditions: Sexual dysfunction post-allogeneic haematopoietic stem cell treatment; haemtological cancers; haematological malignancies; Blood - Haematological diseases; Cancer - Hodgkin's; Cancer - Leukaemia - Acute leukaemia; Cancer - Leukaemia - Chronic leukaemia; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma; Cancer - Myeloma

• Registration Number: ACTRN12620001220954
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-16
• Last Update Posted: 24 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sexual function<br>International Index of Erectile Functioning (IIEF)<br>Female Sexual Function Index (FSFI)[Baseline (pre-intervention) and 2 weeks post-completion of the intervention.];Relationship quality:<br>Perceived Relationship Quality Components Inventory (PRQC)<br>[The PRQC will be administered at baseline (pre-intervention) and 2 weeks post-completion of intervention.<br><br>];Patient and partner satisfaction with intervention will be assessed using study-specific questionnaires.<br><br>[Following each of the 4 sessions of the psychological intervention component, and 2 weeks post-completion of the intervention]