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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02458001
Other study ID # HTA 11/111/02
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 20, 2015
Last updated May 28, 2015
Start date July 2015
Est. completion date March 2017

Study information

Verified date May 2015
Source University College, London
Contact Susan F Gessler, PhD
Phone 00442034478636
Email s.gessler@ucl.ac.uk
Is FDA regulated No
Health authority United Kingdom: National Institute for Health Research
Study type Interventional

Clinical Trial Summary

Women affected by gynaecologic cancers are often not aware of sexual consequences of cancer and its treatment. Most do not receive appropriate advice or help to recover sexual function, and the impact on their sexuality may be profound. Despite this several potential therapies can be effective in helping recovery. A major challenge is informing and involving the patients in an appropriate and sensitive manner, and a further issue is the delivery of such therapies in busy and medically driven gynaecologic oncology clinics. It will use and adapt existing evidence based therapies for improving sexual function after cancer treatment and develop a model for delivering these in the NHS (United Kingdom National Health Service) setting. The model of 'stepped care' is adapted from that used nationally and successfully in the Increasing Access to Psychological Therapies (IAPT) programme. Assessment allows for 'stepping up and down', i.e. calibrating the type of help a woman receives according to need and her response to treatment already given.This study will develop and evaluate a 'stepped' system of interventions using elements of best available evidence, adapting existing interventions to help women recover their sexual feelings and activity, starting with simple methods, moving on to new talking treatments for more complex cases. The investigators address all gynaecologic cancers on the principle that sexual difficulty is the problem the investigators are treating, not the cancer of origin. Ongoing clinical assessment will be vital for the success of the stepped care model. The investigators will deliver training and supervision to enhance the skills needed by the Clinical Nursing Specialist (CNS). An important part of this study will be characterising the range of women and their willingness to participate in psychosexual help. One-to-one follow up interviews will inform the level of input required for any subsequent Randomised Control Trial (RCT). The investigators will use internationally recognised rating scales for rating sexual function, assess how illness and treatment affect mood and self esteem. The investigators will also measure the overall cost-effectiveness to the public sector of providing this treatment, compared to costs of subsequent use of health and social services. This pilot 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.


Description:

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Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
SAFFRON stepped care
Behavioral: SAFFRON stepped care Stepped care (Improving Access to Psychological Therapies, 2012; Richards et al., 2012) adapted for the gynaecological cancer setting to produce a 3-step model including a clinical assessment and treatment algorithm. Assessment Algorithm FSFI Interventions Level 1: Best available self-help literature on psychosexual difficulties after cancer as judged by the project team and two patient advocates. Level 2: A 3-5 session manualised psycho-educational intervention delivered fortnightly by study trained CNSs with taping and supervision for adherence to protocol and manual. Level 3: 16 weekly session manualised brief psychotherapy adaptation of InterPersonal Therapy, IPT (Interpersonal Psychotherapy for Sexual Adjustment post Gynaecological Cancer, IPT-APGyC)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University College, London

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of recruitment measure of feasibility 24 months No
Primary Consent rate to randomization and treatment measure of feasibility 24 months No
Primary Proportion of women stepping up from level 1 to 2, and level 2 to 3 measure of feasibility 24 months No
Primary Proportion of women dropping out of therapy measure of feasibility 24 months No
Primary Number of usable data points from all measures at all time points measure of feasibility 24 months No
Primary Proportion of women lost to follow-up on trial measures measure of feasibility 24 months No
Secondary Change in Female Sexual Function Index (FSFI) shows whether interventions have changed sexual functioning 24 months No
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