Condition category
Cancer
Date applied
04/06/2015
Date assigned
04/06/2015
Last edited
13/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review with external organization

Trial website

Contact information

Type

Public

Primary contact

Dr Sue Gessler

ORCID ID

http://orcid.org/0000-0001-9434-8718

Contact details

UCLH Gynaecological Cancer Centre
Honorary Senior Lecturer
Institute for Women's Health
University College London
2nd Floor North
250 Euston Road
London
NW1 2PG
United Kingdom
+44 (0)203 447 8636
s.gessler@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02458001

Protocol/serial number

HTA 11/111/02; v12

Study information

Scientific title

Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer: a feasibility pilot study two-arm, parallel-group, randomized controlled trial

Acronym

SAFFRON

Study hypothesis

Feasibility pilot study with research questions as follows:
1. To establish whether women treated for gynaecological cancer with moderate to severe sexual dysfunction are willing to participate in a randomised trial model and adhere to treatment
2. To indicate likely rates of recruitment to a future evaluation of the SAFFRON intervention
3. To pilot a stepped care psychosexual intervention (SAFFRON) on the IAPT model
4. To establish whether the SAFFRON intervention is acceptable to patients
5. To establish whether SAFFRON is deliverable by a Gynae-Oncology cancer centre multi-disciplinary team
6. To indicate the most appropriate outcome measures for use in a larger trial
7. To inform estimates of the likely effect size, which will assist sample size calculations for a larger trial

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1111102
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0008/98765/PRO-11-111-02.pdf

Ethics approval

NRES Committee London - Queen Square, 12/03/2015, REC ref: 15/LO/0324, IRAS project ID: 138836

Study design

A feasibility pilot study two-arm, parallel-group, randomized controlled trial to gain appropriate information to inform a decision about progressing to a full randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Psycho-sexual difficulties following treatment for gynaecological cancer

Intervention

Intervention Arm: SAFFRON stepped care. Stepped care (Improving Access to Psychological Therapies, 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)

Control Arm: Enhanced Treatment as Usual 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

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Primary endpoints – measures of feasibility:
1. Rate of recruitment
2. Consent rate to randomization and treatment
3. Proportion of women stepping up from level 1 to 2, and level 2 to 3
4. Proportion of women dropping out of therapy
5. Number of usable data points from all measures at all time points
6. Proportion of women lost to follow-up on trial measures

Secondary outcome measures

At all 5 time-points (baseline, 6 weeks, 3 months, 6 months, 12 months) the following will be recorded:
1. Change in Female Sexual Function Index (FSFI) (Rosen et al 2000), an internationally recognized rating scale which allows women to describe their sexual experience in a range of domains - desire, arousal, lubrication, orgasm, pain and satisfaction. Cut-off scores FSFI ≤ 26 signifies sexual dysfunction (lower scores signify worse sexual function (Rosen et al, 2000, Baser et al 2012).
2. Change in mood and other measures:
2.1. Economics: EQ 5D to measure cost effectiveness.
2.2. Depression: Patient Health Questionnaire (PHQ-9). ≤ 20 signifies moderate to severe depression (Kroenke et al, 2001).

Preference will be given to face-to-face administration of questionnaire measures in clinic, or if necessary, at home. Data will be maximised by posting questionnaires if necessary with a telephone interview to follow up.

At 6 and 12 months we will also record:
Client Services Receipt Inventory (CSRI) short form to assess use of health and social services (Beecham and Knapp 1992)

At baseline (randomisation) the following additional demographic and clinical information will be recorded on a Case Report Form (CRF) by the RA, including:
1. Demographics: ethnicity, current relationship status, occupation, education.
2. Personal history: within a relationship: gender of partner; self-rated quality of relationship measure.
Disease information: cancer diagnosis (cervix, ovarian, endometrial, other), stage of disease at diagnosis, time since end of primary treatment in months, stage of disease at last appointment (relapse or first line treatment), treatment modality.
3. ECOG/WHO Performance status (0-5) assessed by clinician where 0 = fully active, able to carry on all pre-disease performance without restriction, 5 = dead (Oken et al 1982)
All cancer disease information will be gathered by the RA on each site from electronic records and crosschecked against the hospital database on all Gyn-Onc patients.

Process Measures:
1. Qualitative feedback from patients about their experience of participating in the trial
2. Qualitative feedback from staff about implementation of study within clinics

Overall trial start date

01/04/2014

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women over 18 (with partners at their choice) treated for any gynaecological malignancy with surgery and/or chemotherapy and/or radiation at UCLH Gynaecological Cancer Centre or University Hospitals Bristol Gynaecological Cancer Centre
2. 3 months minimum post end of treatment
3. Any sexual orientation
4. With sexual function difficulties identified by initial screen (3 clinical questions within clinical interview posed by doctor or nurse)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

1. Poor English
2. Current drug or alcohol abuse
3. Current sexual therapy or psychotherapy

Recruitment start date

01/07/2015

Recruitment end date

21/03/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UCLH Gynaecological Cancer Centre
2nd Floor North 250 Euston Road
London
NW1 2PG
United Kingdom

Trial participating centre

University Hospitals Bristol Gynaecological Oncology Centre
University Hospitals Bristol Gynaecological Oncology Centre St Michael's Hospital
 Southwell Street
Bristol
BS2 8EG
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Joint Research Office
University College London
Gower Street
London
WC1E 6BT
United Kingdom
+44 (0)203 447 7430
Suzanne.Emerton@uclh.nhs.uk

Sponsor type

University/education

Website

www.ucl.ac.uk/jro

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The main outputs from this research will be:
1. New therapeutic materials and therapeutic intervention
2. A new format of delivery (stepped care) which will raise the issue of sexuality more widely in follow-up for all women treated for gynaecological cancer. However, we shall not be able to provide evidence of effectiveness from this pilot trial. Rather we are developing a promising and empirically based intervention whose evaluation we shall pilot. Although services may be interested in it, we shall stress that further evidence on its effectiveness will be needed before it can be recommended more generally.
3. We will publish the protocol of the study initially, together with papers describing the process of developing the 3 levels of intervention.
4. The ultimate aim of this study – and any subsequent RCT – is to evaluate the effectiveness of a stepped intervention delivery model within NHS clinics to improve sexual outcome in women treated for gynaecological cancer. We will therefore use a variety of approaches, some London and Bristol based and some national, to disseminate our findings.
5. Results will be presented to both cancer centres that participated in the research. Participating patients will also be offered the opportunity to receive a summary of the findings or to view the results on the study web pages described above. Other forms of dissemination will include the publication of peer-reviewed articles, and presentation at conferences and seminars for practitioners, researchers, national policy makers, and users. The quantitative and qualitative study outputs will be assembled to inform the main randomised controlled trial. This will be the subject of a subsequent grant application. For example, the qualitative interviews will help to identify deficits and gaps in the treatment manuals, current practices, training and supervisory arrangements which will be revised for the main trial evaluation.
6. The patient and carer organisations who have been fully involved in the research will also assist with the wider dissemination of the results through their consumer networks. Macmillan Cancer Support are supportive of this endeavour and Julie Latimer, Education Lead of Macmillan London has engaged to roll out any findings. In addition, we will collaborate with the UCLH/UCL Patient and Public Involvement (PPI) in Research Co-ordinator and with the UCLH/UCL press offices to develop contacts with local and national media and to contribute material for the UCL/UCLH websites (including to the dedicated pages on the Research Patients Support Network and PPI in Research). Training courses in Communicating Science to the Public will be completed by the researchers.

Intention to publish date

01/01/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/07/2016: Internal review.