Trial record 15 of 197 for:    Vaginal Cancer: Clinical Trials

Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer (SAFFRON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02458001
Recruitment Status : Unknown
Verified May 2015 by University College, London.
Recruitment status was:  Not yet recruiting
First Posted : May 29, 2015
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
University College, London

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Ovarian Cancer Uterine Cancer Vaginal Cancer Vulval Cancer Psychosexual Dysfunctions Behavioral: SAFFRON stepped care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Developing a Stepped Approach to Improving Sexual Function After Gynaecological Cancer- a Feasibility Study and Randomized Controlled Trial
Study Start Date : July 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: SAFFRON stepped care
3 level intervention: level 1:Self help booklet level 2: CNS delivered intervention level 3: psychologist delivered 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)

No Intervention: enhanced treatment as usual (ETU)
level 1 intervention: self help booklet Non study trained CNS will offer assessment, advice, vaginal dilator training where appropriate, arrange topical oestrogens or other creams

Primary Outcome Measures :
  1. Rate of recruitment [ Time Frame: 24 months ]
    measure of feasibility

  2. Consent rate to randomization and treatment [ Time Frame: 24 months ]
    measure of feasibility

  3. Proportion of women stepping up from level 1 to 2, and level 2 to 3 [ Time Frame: 24 months ]
    measure of feasibility

  4. Proportion of women dropping out of therapy [ Time Frame: 24 months ]
    measure of feasibility

  5. Number of usable data points from all measures at all time points [ Time Frame: 24 months ]
    measure of feasibility

  6. Proportion of women lost to follow-up on trial measures [ Time Frame: 24 months ]
    measure of feasibility

Secondary Outcome Measures :
  1. Change in Female Sexual Function Index (FSFI) [ Time Frame: 24 months ]
    shows whether interventions have changed sexual functioning

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women over 18 (with partners at their choice) treated for any gynaecological malignancy with surgery and/or chemotherapy and/or radiation at UCLH (University College London Hospitals) Gynaecological Cancer Centre or University Hospitals Bristol Gynaecological Cancer Centre
  • 3 months minimum post end of treatment
  • any sexual orientation
  • with sexual function difficulties identified by initial screen (3 clinical questions within clinical interview posed by doctor or nurse)

Exclusion Criteria:

  • Poor English
  • Current drug or alcohol abuse
  • Current sexual therapy or psychotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02458001

Contact: Susan F Gessler, PhD 00442034478636
Contact: Anne Lanceley, PhD 00442076796807

Sponsors and Collaborators
University College, London
Principal Investigator: Susan F Gessler, PhD University College, London

Responsible Party: University College, London Identifier: NCT02458001     History of Changes
Other Study ID Numbers: HTA 11/111/02
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vaginal Diseases
Sexual Dysfunctions, Psychological
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Mental Disorders
Vulvar Diseases