Clinical trial NCT06046716: The Impact of Mindful Compassion on Sexual Functioning Post Breast Cancer Treatment
Official title: A Preliminary Randomised Clinical Trial Looking at the Impact of State-mindful Self-compassion on Sexual Function Post-breast Cancer Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Functioning
Keywords: cancer
cancer treatment
wellbeing
sexual self efficacy
quality of life
Lead sponsor: London Metropolitan University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomised control waitlist n=28 active experimental group and n=24 waitlist control delayed group
Primary purpose: TREATMENT

Brief 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 behaviour change techniques as part of the online intervention. These have been mapped to a behaviour change 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 randomised controlled trial looking at sexual self-efficacy, well-being, sexual desire, mindfulness and self-compassion.

Quantitatively, the research is structured so that participants will be randomised 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 12 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 National Health Service 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)

Eligibility criteria: Inclusion Criteria:

* Must be registered with a General Practitioner
* Must be registered with a healthcare service which supports post-cancer treatment
* Have sexual desire before cancer diagnosis
* Must be aged 18 years or older
* Must be able to read and write English
* Clinical diagnosis of cancer diagnosis via the National Health Service Services
* The Patient Health Questionnaire screening score would be between minimal to mild, 0-9.

Exclusion Criteria:

* Currently receiving cancer treatments
* Completed cancer treatments within six months
* Are not registered with a General Practitioner
* Are not registered with healthcare services providing post-cancer support
* Aged below 18 years old
* Reading and writing English difficulties
* Self-perceived low/minimal sexual desire before cancer diagnosis (lifelong)
* A terminal illness/end-of-life
* The Patient Health Questionnaire score range would be between moderate to severe, 10-27.

Primary outcomes:
measure: Patients Health Questionnaire
timeFrame: This is taken at week 0
measure: Female Sexual Function Index
timeFrame: Weeks 0, 4 and 12
measure: Adapted Sexual Self-efficacy Erectile Tool
timeFrame: Weeks 0, 4 and 12
measure: The Short Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: Weeks 0, 4 and 12
measure: The Brunnsviken Brief Quality of Life Scale
timeFrame: Weeks 0,4 and 12
measure: The Self-compassion Scale
timeFrame: Weeks 0, 4 and 12
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London Met university
Study officials:
affiliation: London Metropolitan Univeristy
name: Samantha Banbury, PhD
role: PRINCIPAL_INVESTIGATOR
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