Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer (SAFFRON)
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Ovarian Cancer Uterine Cancer Vaginal Cancer Vulval Cancer Psychosexual Dysfunctions||Behavioral: SAFFRON stepped care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
Best available self-help literature on psychosexual difficulties after cancer as judged by the project team and two patient advocates.
A 3-5 session manualised psycho-educational intervention delivered fortnightly by study trained CNSs with taping and supervision for adherence to protocol and manual.
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
- Rate of recruitment [ Time Frame: 24 months ]measure of feasibility
- Consent rate to randomization and treatment [ Time Frame: 24 months ]measure of feasibility
- Proportion of women stepping up from level 1 to 2, and level 2 to 3 [ Time Frame: 24 months ]measure of feasibility
- Proportion of women dropping out of therapy [ Time Frame: 24 months ]measure of feasibility
- Number of usable data points from all measures at all time points [ Time Frame: 24 months ]measure of feasibility
- Proportion of women lost to follow-up on trial measures [ Time Frame: 24 months ]measure of feasibility
- Change in Female Sexual Function Index (FSFI) [ Time Frame: 24 months ]shows whether interventions have changed sexual functioning
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 ClinicalTrials.gov identifier (NCT number): NCT02458001
|Contact: Susan F Gessler, PhDemail@example.com|
|Contact: Anne Lanceley, PhDfirstname.lastname@example.org|
|Principal Investigator:||Susan F Gessler, PhD||University College, London|