Ovarian Cancer Clinical Trial
Official title:
Developing a Stepped Approach to Improving Sexual Function After Gynaecological Cancer- a Feasibility Study and Randomized Controlled Trial
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.
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?
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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