A Preliminary Randomised Clinical Trial Looking at the Impact of State-mindful Self-compassion on Sexual Function Post-breast Cancer Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- The Short Warwick-Edinburgh Mental Wellbeing Scale
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The Short Warwick-Edinburgh Mental Wellbeing Scale
时间窗: Weeks 0, 4 and 12
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. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing.
Adapted Sexual Self-efficacy Erectile Tool
时间窗: Weeks 0, 4 and 12
This is a 15-item questionnaire which focuses on sexual confidence and behaviour change associated with therapy. Participants' responses are measured by a 10-item scale ranging from 1 to 10 with 1 being the lowest level of self-efficacy and 10 is the highest. Scores range from 15 to 150 with higher levels representing higher levels of sexual self-efficacy. There is no reverse scoring.
Patients Health Questionnaire
时间窗: This is taken at week 0
Measures levels of depression for inclusion and exclusion criteria. The score ranges between 0 and 27, with a higher score representing higher levels of depression.
Female Sexual Function Index
时间窗: Weeks 0, 4 and 12
This is a 19-item questionnaire on sexual function, including sexual desire, orgasm, lubrication, sexual satisfaction and pain. It has five response categories. Scores include severe 2-7.2, moderate 7.3-14.4, mild to moderate 14.5-21.6, mild 21.7- 28.1 cut-off value, and no female sexual dysfunction 28.2 -36.The lower the score, the higher the level of sexual dysfunction.
The Brunnsviken Brief Quality of Life Scale
时间窗: Weeks 0,4 and 12
An 8-item questionnaire with five response categories looking at satisfaction with self, friends, family and creativity. The total score is calculated by summing the satisfaction ratings and summing the six products for a total score with score range between 0-96.
The Self-compassion Scale
时间窗: Weeks 0, 4 and 12
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 and self-judgement, common humanity and isolation, and mindfulness and over-identification with painful thoughts and emotions. Scores range between. An estimated score between 1-2.5 for overall self-compassion score indicates low levels of self-compassion. 2.5-3.5 indicates moderate. 3.5-5.0 means high levels of overall self-compassion.
次要结局
未报告次要终点
研究者
Samantha Banbury
Reader
London Metropolitan University