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

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Brief Title

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

Official Title

Developing a Stepped Approach to Improving Sexual Function After Gynaecological Cancer- a Feasibility Study and Randomized Controlled Trial

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.
    

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

        1. Will women agree to be randomized to a sexuality intervention?

        2. Are different tumor sites, treatments, cancer stages at approach associated with
           different rates of uptake of therapy/intervention of recruitment to trial?

        3. Is stepped care operable within the NHS system as it stands?

        4. What is the likely effect of three levels of intervention on sexual function, mood and
           self-esteem as measured by standard measures?

        5. 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

Interventional


Primary Outcome

Rate of recruitment

Secondary Outcome

 Change in Female Sexual Function Index (FSFI)

Condition

Cervical Cancer

Intervention

SAFFRON stepped care

Study Arms / Comparison Groups

 SAFFRON stepped care
Description:  3 level intervention: level 1:Self help booklet level 2: CNS delivered intervention level 3: psychologist delivered intervention

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

100

Start Date

July 2015

Completion Date

March 2017

Primary Completion Date

March 2017

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Susan F Gessler, PhD, 00442034478636, [email protected]



Administrative Informations


NCT ID

NCT02458001

Organization ID

HTA 11/111/02


Responsible Party

Sponsor

Study Sponsor

University College, London


Study Sponsor

Susan F Gessler, PhD, Principal Investigator, University College, London


Verification Date

May 2015