Improving sexual function after treatment for gynaecological cancer
Research type
Research Study
Full title
Developing a Stepped Approach to improving sexual Function aFteR treatment fOr gyNaecological cancer (SAFFRON)
IRAS ID
138836
Contact name
Susan Gessler
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2015/01/74, UCL Data Protection Number
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
This feasibility trial will develop a “stepped care” system of interventions for psychosexual difficulties experienced by women treated for gynaecological cancer. Treatments and treatment information will be developed. The second part of the study will assess the feasibility of conducting a full scale investigation of a stepped therapy and indicate the potential benefits to the patients, their partners, and to the NHS generally.
Eligible women will be recruited from gynaecological cancer centres in London and Bristol. Women over 18 years, treated for gynaecological cancer, at least 3 months post-treatment, with sexual function difficulties identified during a usual clinic consultation with their doctor or nurse will be invited to take part. Consenting women will be randomised to enhanced treatment as usual or to the stepped system intervention arm. Stepped-care consists of 3-steps together with an algorithm for assigning treatment level. The system starts with simple methods – psychoeducational and self-help materials - moving on to low intensity interventions delivered by a study trained clinical nurse specialist (CNS). The third step is new talking treatments delivered by psychologists for more complex cases based on theories of how we treat loss and depression. An initial assessment will determine which step is a suitable start and women can be progressed from one therapy to another as appropriate using a newly developed algorithm based on international rating scale sessional scores for sexual function and self-esteem. Ongoing clinical assessment will be vital for the success of the stepped care model. Training and supervision will be delivered to enhance the skills of the CNSs.
The feasibility study will characterise the range of women and their willingness to participate in psychosexual help. It will also measure cost effectiveness. One to one follow-up interviews with participants and involved clinicians will inform the level of input required for any subsequent Randomised Control Trial (RCT).REC name
London - Queen Square Research Ethics Committee
REC reference
15/LO/0324
Date of REC Opinion
2 Mar 2015
REC opinion
Favourable Opinion