The Impact of Mindful Compassion on Sexual Functioning Post Breast Cancer Treatment
Condition: Sexual Functioning
Study type: Interventional

Summary: 
      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: 
      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)
    

Intervention name(s): Mindful compassion based on behavioural change taxonomy experimental group
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized control waitlist n=28 active experimental group and n=24 waitlist control delayed group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cancer; cancer treatment; wellbeing; sexual self efficacy; quality of life