The Impact of Mindful Compassion on Sexual Functioning Post Breast Cancer Treatment

Study Overview
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Brief Summary
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Sexual dysfunction is commonly reported post cancer treatments. Sexual desire and body image are interrelated. Indeed, sexual wellbeing can be affected by diagnosis, medication and cancer treatments which can damage body tissues such as the vagina or penis owing to radiation therapy, or insufficient lubrication caused by chemotherapy. Additionally, feeling sore, exhausted, anxious, depressed and 'not in the mood' further contribute to changes in sexual desire Very few evidence-based online interventions have been developed to address sexual difficulties post cancer treatments. This extends to well-being, sexual self efficacy and quality of life. It is imperative that mindful compassion interventions are based on a behavioural taxonomy to support the reliability in the delivery of these interventions. Indeed, this study has set out to identify and describe the key components and BCTs as part of the online intervention. These have been mapped to the BCTTv1 taxonomy with the view of supporting standardisation for future trial implementation. Therefore, the aim of this study is to examine the effectiveness of an online mindful-compassion intervention using the 3-system model of emotions based on the behavioural taxonomy among a post cancer treatment group with the view of improving quality of life. The study intends to provide preliminary estimates of pre-post intervention on a waitlist controlled RCT looking at sexual self-efficacy, well-being, sexual desire, mindfulness, self-compassion, and body image. Quantitatively, the research is structured so that participants will be randomized to either the active experimental or delayed group. This intervention will be weekly for approximately 1 to 2 hours over 4 weeks. This A follow-up at 8 weeks will be taken to determine the sustainability of this intervention.

Detailed Description
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Psychosocial interventions have varied in supporting post cancer treatments. An intervention gaining momentum in NHS practices is mindfulness. Mindfulness can mitigate negative self-thoughts and instead increase wellbeing and sexual self-efficacy which supports sexual functioning. Its applications are diverse and have extended to pre and post cancer treatment interventions. Benefits of mindfulness among post cancer treatment patients include lower levels of anxiety, depression and concerns regarding recurrence. Mindful compassion is gaining popularity in health care. Mindful compassion consists of mindfulness, humanity, and self-kindness. Mindful compassion has been used in psychosexual services including varied sexual presentation such as sexual pain disorder. Indeed, the three systems model can be used to map out validate and normalise different emotional experiences - as well as map out how they can impact sexual arousal and enjoyment. The intervention will be delivered by a qualified practitioner specialised in mindful compassion. Participants will be encouraged to engage with at home exercises including sensate, breathing exercises, sexual desire and fantasy diaries, mindfulness and self-compassion exercise including working with body image. This will be guided by the 3-system model of emotions where focus on mind and body will identify physiological changes to a perceived threat, to cognitively identify and attend to internal and external triggers and to incorporate mindful acceptance and compassion to address the critical inner voice. This will be applied to day to day living as well as applying this to sex, intimacy and body image. The foundation of the intervention will be based on a behavioural change taxonomy. This consists of 93 behaviour change techniques taxonomy in which the relevant taxonomies will be selected for this intervention. Table 1 outlines the foundation of the intervention. In total, 12 domains have been included in the development of this intervention. Of these, 20 out of the 93 Behaviour Change Techniques listed in the behaviour change techniques taxonomy were identified. Table 1 Cognition Psychosexual education - sex and cancer 1.1, 1.2, 1.3, 1.4 Understanding sexual well-being, efficacy, desire, fantasy and intimacy 1.1, 1.2, 1.3, 1.4, 4.1 Understanding mindful compassion- the threat and drive systems (inner critic) 4.1, 6.1, 7.1, 8.1, 8.7,11.2 Cognitive recognition of the internal and external triggers in relation to threat and drive 2.3, 7.1, 12.1, 13.2, 15.4 Recognition and reframe with acceptance (mind and body- soothing) 13.2, 13.4, 15.2, 15.4, 16.2 Mental rehearsal of fantasy, sensate or sex whether literal or imagery 11.2,15.2, 15.4, 16.2 Behavioural Self-care Behaviours 3.3, 12.6, 13.1, 13.4 Self-monitoring towards goals 1.1, 1.3, 2.3 Graded tasks towards sensate, sexual fantasy or sexual practice 8.1, 8.7 Restructuring the physical environment (sex furniture, use of porn etc) 12.1 Breathing exercises to minimise distress and increase calmness and safety 8.1, 8.7, 16.2 Self-acceptance/compassion towards feeling soothed and nurtured Valued self-identity (mind and body) 11.2, 13.1, 13.4 Using sensate to identify body change with acceptance 12.6, 13.1, 13.4 Understanding emotions, feelings and intimacy 3.3, 11.2, 13.1, 13.2, 13.4, 15.2, 15.4, 16.2 Self-directed meditation 4.1, 6.1,8.1, 11.2,15.2 Body scan - better awareness of mind and body (top to toe) 4.1, 6.1, 8.1, 11.2, 15.2 Mindfulness practices and being aware of the present moment 16.2 Mindfulness stretching focusing on mind and body connection 4.1, 6.1, 8.1, 11.2, 15.2 Self-compassion with positive self-identity and sexual embodiment post cancer treatments 11.2, 13.1, 13.2, 13.4, 13.5, 15.3, 15.4 Structuring of intervention (online once a week for 1 to 2 hours) Week 0 (baseline measurements taken) Week 1 Introduction - psychosexual education Week 2 The three-model system of emotions and sexual functioning Week 3 Sexual intimacy and the inner critic Week 4 Embracing life and embodied sexuality post-cancer (commencement of the delayed group)

Official Title
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A Preliminary RCT Looking at the Impact of State-mindful Self-compassion on Sexual Function Post-breast Cancer Treatments

Conditions
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Sexual Functioning

Intervention / Treatment
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* Behavioral: Mindful compassion based on behavioural change taxonomy experimental group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ALL PARTICIPANTS WILL BE AT LEAST 6 MONTHS OR MORE POST CANCER TREATMENTS and be cancer free at the time of the study. Registered with a GP Registered with a healthcare service with access to oncology (GP, cancer doctor or specialist nurse to confirm that there is no risk of infection/radiation through sex/intimacy owing to cancer treatment) Self-perceived satisfactory sexual desire prior to cancer diagnosis (acquired) Age 18 years or older Read and write English Any cancer diagnosis which received treatment via NHS services PHQ-9 screening (score range between minimal to mild 0-9) Exclusion Criteria: Are currently receiving cancer treatments Completed cancer treatments within 6 months Confirmation not sought from the GP, cancer doctor or specialised nurse confirming individual is not susceptible to infection through sex as a consequence of cancer treatment Are not registered with a GP Are not registered with healthcare service (oncology) Aged below 18 years old Reading and writing English difficulties Self-perceived low/minimal sexual desire prior to cancer diagnosis (lifelong) Those with a terminal illness/end of life PHQ-9 screening (score range between moderate to severe - 10-27)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomized control waitlist n=28 active experimental group and n=24 waitlist control delayed group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental mindful compassion group<br>Experimental randomised controlled waitlist study The experimental group (n=28) will receive mindful compassion intervention at week 1 and intervention terminates at week 4 | Behavioral: Mindful compassion based on behavioural change taxonomy experimental group<br>* Since this is a waitlist control study both groups get the same intervention. This is a mindful compassion intervention which is based on the behavioural change taxonomy techniques to support the reliability of the intervention. This will include sensate, mindful exercises, relaxation and attending to the critical voice. The intervention consists of behavioural, cognitive and mindful compassion constructs.<br>|
| Other: Waitlist mindful compassion control group<br>Experimental randomised controlled waitlist study The delayed group (n=24) will receive mindful compassion intervention at week 4 and intervention terminates at week 8 | Behavioral: Mindful compassion based on behavioural change taxonomy experimental group<br>* Since this is a waitlist control study both groups get the same intervention. This is a mindful compassion intervention which is based on the behavioural change taxonomy techniques to support the reliability of the intervention. This will include sensate, mindful exercises, relaxation and attending to the critical voice. The intervention consists of behavioural, cognitive and mindful compassion constructs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary screening tool PHQ-9 | Measures levels of depression for inclusion and exclusion criteria | This is taken at week 1 | 
| Demographic information Demographic Information | Demographic information will include ethnicity, partnered status, sexuality, age, employment status, children, cancer type, cancer treatment used, other health concerns, sexual difficulties, prescription medications and substance use including alcohol consumption and smoking, and levels of exercise. | This will be taken at week 0 | 
| Female Sexual Function Index | This is a 19-item questionnaire on sexual function including sexual desire, orgasm, lubrication, sexual satisfaction and pain. It has five response categories. Example questions include, Over the past four weeks, how often did you feel sexual desire or interest? The higher the score, the higher the level of sexual difficulties. Questions will be adapted and include masturbation. An example question is, During this last month, how often would you have liked to engage in sexual activity with a partner or with yourself | Weeks 0, 4 and 8 | 
| Adapted Sexual Self-efficacy | The Sexual Self-Efficacy Erectile tool is a 15-item questionnaire which focuses on sexual confidence and behaviour change associated with therapy. Participants' responses are measured via a 10-item scale ranging from 1 to 10. Here, 1 is the lowest level of self-efficacy and 10 is the highest. There are no reverse questions. Cronbach's alpha is α =0.88 (high). This questionnaire has been adapted to reflect the participants in a study looking at sexual self-efficacy and sexual dysfunction. Less than 5% of the original questionnaires remain. An example question is, Do you feel sexually desirable to your partner? or others if single? | Weeks 0, 4 and 8 | 
| The Short Warwick-Edinburgh Mental Wellbeing Scale | A 7-item questionnaire with 5 response categories looking at functioning and feeling aspects of well-being. The response categories include 1=none of the time to 5=all of the time. Cronbach alpha- 0.89-0.91. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing. Example questions include, I've been feeling close to other people and I've been feeling relaxed. | Weeks 0, 4 and 8 | 
| Brunnsviken Brief Quality of Life Scale | An 8-item questionnaire with five response categories looking at satisfaction with self, friends, family and creativity. Example responses include how I view my life as necessary for my quality of life, and I am satisfied with my friends and friendship: I have friends I associate with and support me. The Cronbach's alpha α =.760. | Weeks 0,4 and 8 | 
| The Cognitive and Affective Mindfulness Scale-Revised | This is a 10-item measure with 4 response categories 1= rarely/not at all to 4 = almost always, with higher scores indicating higher levels of mindfulness (scores 4-40). An example question is, I can accept things I cannot change. Cronbach's alphas range between 0.82 and 0.84. | Weeks 0, 4 and 8 | 
| Self-compassion Scale | This is a 12-item measure with five response categories, 1 = almost never to 5= almost always, with higher scores indicating higher levels of self-compassion. The questionnaire measures self-kindness vs. self-judgement, common humanity vs. isolation, and mindfulness vs. over-identification with painful thoughts and emotions. Reliability Cronbach's alphas range between .680 and .780. | Weeks 0, 4 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, cancer treatment, wellbeing, sexual self efficacy, quality of life