- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02458001
Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer (SAFFRON)
Developing a Stepped Approach to Improving Sexual Function After Gynaecological Cancer- a Feasibility Study and Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Many cancer patients have sexual difficulties , gynaecologic cancer (Gyn-Onc) patients are particularly vulnerable to changes in sexual activity and lack of sexual desire with sexual difficulty rates estimated between 40 and 100% . Women undergo a range of treatments for ovarian, cervix, womb and vulval cancer with different combinations of surgery, chemotherapy, and radiation. Some treatments have a deleterious effect on women's internal and external sex organs, surrounding tissues and nerves, and render some menopausal. Following such treatments women report a wide range of difficulties including loss of libido, dyspareunia, vaginal dryness, and orgasmic difficulty. In addition, the symptom burden of gynaecologic cancers is heavy with many women reporting pain, fatigue, changes in bowel function, urinary symptoms including leakage, and depression and anxiety which interact with menopausal and sexual difficulties. The major impact of physical well-being on sexual function has been noted, as well as the lack of relationship between extent of treatment and formal scores of sexual function. Unsurprisingly, women treated for gynaecologic cancer are at high risk of emotional distress. One prevalence study found 23% satisfying criteria for major depressive disorder and another found greater depressive symptoms in gyn-onc patients than in breast, urology or gastro intestinal cancers. It is suggested that some of the depressive symptoms are related to the very high levels of sexual difficulty experienced after treatment. Some suggest that sexual self schema is an important moderator of response, finding positive sexual self schema associated with more frequent sexual activity, better sexual responsiveness, and higher global sexual satisfaction across all disease sites and confounders, suggesting it makes women more resilient to the adverse sexual impacts of gynaecologic cancer. Despite their sexual difficulties, many gynaecologic cancer survivors resume intercourse. Frequency of intercourse in one sample was comparable to available norms for similarly aged women, but these and other longitudinal data have shown sexual satisfaction and responsiveness significantly impaired following treatment. Patients report sexuality rarely addressed by physicians. It has been found that conversation with physicians about sexual effects of cancer is associated with significantly lower likelihood of complex sexual morbidity among very long-term survivors; but 62% of 221 participants reported their physician had never initiated a discussion about sexuality after cancer. Examining sexuality in palliative care, it has been found that patients consider it important to talk about sexuality and to face it with an experienced professional even though life expectancy is short. Patients in that study had not had this opportunity. Moreover, some patients were still able to maintain a sufficient sexual activity, in terms of quality and quantity.Nursing researchers found that cancer nurses were more likely to focus on the technical aspects of sexual recovery post treatment, for example vaginal dilation, and offered minimal advice or opportunities for disclosure for sexual dysfunctions, dissatisfaction with partner relationships or mood and other psychological difficulties. Clinical Nurse Specialists (CNSs) in gynaecologic cancer acknowledge that they have an important role in this aspect of care but do not always feel confident or competent to assess or manage patients psycho-sexual needs, and appropriate referral is then problematic . A recent review of specific complaints of all cancer patient referrals to the Sexual Health Program of the Memorial Sloan Kettering Cancer Center found that most sought help for painful intercourse (65%), vaginal dryness (63%), low sexual desire (46%), and orgasmic disorder (7%). The first two of these are partially managed through current best treatment, i.e. topical estrogen, vaginal dilators and lubricants. Prevalence reports by cancer site include a comparison of crude prevalence (66.67%) with age-standardized prevalence (55%) in cervical cancer. Many other studies report ranges from 83% sexual difficulties, to 66% significant and 46% moderate difficulties. In early stage cervix cancer treated with radical hysterectomy, 65.8% were reported to have sexual difficulties. In contrast with most sexual therapy interventions where anxiety reduction is often key, management of low sexual desire in the context of gynaecologic cancer requires an intervention which additionally addresses the wider range of mediating factors, including loss, life-threat, trauma, change of body image, pre-existing psychological outlook, mood, depression and anxiety symptoms as well as the relationship within which the woman finds herself. A wide range of non-controlled trials of sexual therapy interventions are reported in reviews across a range of interventions. All show small effect sizes, but are accompanied by patient satisfaction. A Cochrane Review of RCTs for psycho-sexual dysfunction in women treated for gynaecologic cancer concluded, 'there is insufficient evidence to support or refute the use of any interventions for psychosexual dysfunction after gynaecologic cancer.' Further, they suggested that future trials required multi-center RCTs with outcome measures validated in gynaecologic cancer patients. 'When considering interventions to trial, the investigators would suggest that investigators should focus on interventions that can be delivered by existing members of the multidisciplinary team treating women with gynaecologic cancers. It is more likely that such measures, if found effective, will be affordable and capable of being integrated into standard care. An international consensus on outcome measures would greatly facilitate the comparison of interventions in the future.' This study attempts to address this for the NHS by using the existing multi-disciplinary team to deliver a stepped care approach. This involves CNS delivered interventions at step 1 and step 2 as the major treatment delivery, and only a small minority of more complex psychological issues being treated at step 3 by a level 4 practitioner to whom patients should have access according to peer review.From the evidence above, it is often the case that women affected by gynaecologic cancer are not aware of basic information about the sexual consequences of their gynaecologic cancer and its treatment, and do not receive appropriate advice or help to recover sexual function, and adapt to their changed body and relationships. It is generally recognized by two Cochrane reviews that new interventions are needed for sexual dysfunction in gynaecological cancer and these need to be examined in multi-center RCTs with agreed outcome measures. There is a sizable population with these problems to be addressed as there are currently 1.8 million people in England living with and beyond cancer, and 2 million across the UK as a whole. This number is likely to grow by over 3% per year, reflecting the increasing incidence of cancer and better survival rates. By 2030 there are likely to be around 3 million cancer survivors in England. Since the investigators have the ability to develop suitable treatments, the investigators have a duty to explore them. The current acceptance of the worth of well-being, and conversely the cost of depression, anxiety or unwillingness to engage with the healthcare system - all potential long term effects for the patient group concerned - are drivers for this research. Better awareness of mental health issues and depression in general and in cancer patients plus greater acceptance that these symptoms have causes which can be treated or addressed is relevant too. In addition the work is planned at a time when there is more awareness of sexual health, and evidence from cancer user groups, policy makers) and research of more openness to discuss these matters as a medical need. The potential of CNSs to deliver interventions to help with the consequences of cancer treatment has been recognized by the UK Department of Health yet little is known about CNS's training or supervisory needs to provide interventions for psycho-sexual dysfunction to work alongside psychologists. If care pathways exist for addressing sexual dysfunction in cancer they are currently unique to individual units; providing the evidence for pathways which better meet the requirements of the population will facilitate clinical application of more appropriate and consistent practice. What is needed is a study to develop interventions and test them to facilitate best practice in treatment of sexual dysfunction for all relevant women in gynaecologic cancer centres.
Trial objectives:Aims: To establish whether women treated for gynaecologic cancer with moderate to severe sexual dysfunction are willing to participate in a randomized trial model and adhere to treatment 1)To indicate likely rates of recruitment to a future evaluation of the SAFFRON intervention2)To pilot a stepped care psycho-sexual intervention (SAFFRON) on the IAPT model3)To establish whether the SAFFRON intervention is acceptable to patients4)To establish whether SAFFRON is deliverable by a Gyn-Onc cancer center multidisciplinary team;5)To indicate the most appropriate outcome measures for use in a larger trial6)To inform estimates of the likely effect size, which will assist sample size calculations for a larger trial Research questions:To establish whether women treated for gynaecological cancer with moderate to severe sexual dysfunction are willing to participate in a randomized trial model and adhere to treatment
- Will women agree to be randomized to a sexuality intervention?
- Are different tumor sites, treatments, cancer stages at approach associated with different rates of uptake of therapy/intervention of recruitment to trial?
- Is stepped care operable within the NHS system as it stands?
- What is the likely effect of three levels of intervention on sexual function, mood and self-esteem as measured by standard measures?
- What is the rate of attrition from each treatment modality? Purpose of Research a)Is it possible to improve sexual functioning for women treated for gynaecological cancer within the current clinical setting of NHS gynaecological cancer treatment?b)Can a suitable intervention be developed and evaluated in a feasibility trial?c)Can a suitable intervention be developed and evaluated in a feasibility trial?d)Is a stepped approach acceptable and practical?e)Can it be done within NHS settings?
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susan F Gessler, PhD
- Phone Number: 00442034478636
- Email: s.gessler@ucl.ac.uk
Study Contact Backup
- Name: Anne Lanceley, PhD
- Phone Number: 00442076796807
- Email: a.lanceley@ucl.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of recruitment
Time Frame: 24 months
|
measure of feasibility
|
24 months
|
Consent rate to randomization and treatment
Time Frame: 24 months
|
measure of feasibility
|
24 months
|
Proportion of women stepping up from level 1 to 2, and level 2 to 3
Time Frame: 24 months
|
measure of feasibility
|
24 months
|
Proportion of women dropping out of therapy
Time Frame: 24 months
|
measure of feasibility
|
24 months
|
Number of usable data points from all measures at all time points
Time Frame: 24 months
|
measure of feasibility
|
24 months
|
Proportion of women lost to follow-up on trial measures
Time Frame: 24 months
|
measure of feasibility
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Female Sexual Function Index (FSFI)
Time Frame: 24 months
|
shows whether interventions have changed sexual functioning
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan F Gessler, PhD, University College, London
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HTA 11/111/02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on SAFFRON stepped care
-
Peter Lindenauer, MDBerkshire Medical CenterRecruitingChronic Obstructive Pulmonary Disease | Angina, Stable | Congestive Heart FailureUnited States
-
Seattle Children's HospitalUniversity of WashingtonCompleted
-
Children's National Research InstituteBaylor College of Medicine; National Institute of Diabetes and Digestive and... and other collaboratorsCompletedDiabetes Mellitus, Type 1
-
University of LeipzigCompleted
-
Baylor College of MedicineCompletedObsessive-Compulsive Disorder | Anxiety Disorders | Generalized Anxiety Disorder | Autism Spectrum Disorder | Social Anxiety Disorder | Specific Phobia | Cognitive Behavioral TherapyUnited States
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Not yet recruitingChronic Pain | Posttraumatic Stress DisorderUnited States
-
Massachusetts General HospitalTerminated
-
Children's Hospital of PhiladelphiaCenters for Disease Control and PreventionCompletedStress Disorders, PosttraumaticUnited States
-
Stanford UniversityCompleted
-
University of WashingtonPatient-Centered Outcomes Research InstituteCompletedPost Traumatic Stress Disorder | Post Traumatic Concerns | Depression and Suicide Ideation | Alcohol and Drug UseUnited States