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

NCT02458001 | Unknown DMC

• 1 other identifier: HTA 11/111/02
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer; Ovarian Cancer; Uterine Cancer; Vaginal Cancer; Vulval Cancer; Psychosexual Dysfunctions

Outcome Measures

Primary Outcomes (6)

• Rate of recruitment

  measure of feasibility

  24 months

• Consent rate to randomization and treatment

  measure of feasibility

  24 months

• Proportion of women stepping up from level 1 to 2, and level 2 to 3

  measure of feasibility

  24 months

• Proportion of women dropping out of therapy

  measure of feasibility

  24 months

• Number of usable data points from all measures at all time points

  measure of feasibility

  24 months

• Proportion of women lost to follow-up on trial measures

  measure of feasibility

  24 months

Secondary Outcomes (1)

• Change in Female Sexual Function Index (FSFI)

  24 months

Study Arms (2)

SAFFRON stepped care

EXPERIMENTAL

3 level intervention: level 1:Self help booklet level 2: CNS delivered intervention level 3: psychologist delivered intervention

Behavioral: SAFFRON stepped care

enhanced treatment as usual (ETU)

NO INTERVENTION

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

Interventions

SAFFRON stepped care BEHAVIORAL

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)

SAFFRON stepped care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead

Related Publications (1)

• Gessler S, King M, Lemma A, Barber J, Jones L, Dunning S, Madden V, Pilling S, Hunter R, Fonagy P, Summerville K, MacDonald N, Olaitan A, Lanceley A. Stepped approach to improving sexual function after gynaecological cancer: the SAFFRON feasibility RCT. Health Technol Assess. 2019 Feb;23(6):1-92. doi: 10.3310/hta23060.

  PMID: 30798790 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Ovarian Neoplasms; Uterine Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms; Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Vaginal Diseases; Vulvar Diseases; Mental Disorders

Study Officials

• Susan F Gessler, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan F Gessler, PhD

CONTACT

00442034478636; s.gessler@ucl.ac.uk

Anne Lanceley, PhD

CONTACT

00442076796807; a.lanceley@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: May 29, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 29, 2015

Record last verified: 2015-05