- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07296796
The Impact of Mindful Compassion on Sexual Functioning and Quality of Life in Home Hospice Care
The Impact of Mindful Compassion on Supporting Women Post-cancer Treatment's Sexual Functioning and Quality of Life in Home Hospice Care: A Preliminary Randomised Controlled Trial.
Sexual dysfunction is commonly reported post cancer treatments. Indeed, sexual wellbeing can be affected by diagnosis, medication and cancer treatments, which can damage body tissues such as the vagina 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 and in hospice at home care. This extends to well being and quality of life. Mindful compassion interventions has been based on a behavioural taxonomy to support the reliability of their delivery. Indeed, this study aims 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 among a post cancer treatment group in hospice care, at the end of life, to improve quality of life. The study intends to provide preliminary estimates of pre-post intervention on a waitlist controlled randomised controlled trial looking at well being, sexual function, 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. Feedback questions will also be given during the delivery of the intervention.
Study Overview
Status
Intervention / Treatment
Detailed Description
Hospice care is a specialised form of palliative care provided during the later stages of life. Although these two types of care share some similarities, they can differ in timing, location, and available treatments. Hospice care can be delivered at home or in a hospice healthcare centre. While the main treatments are generally discontinued, pain management and support for other health issues, such as high blood pressure or psychological distress like anxiety or depression, may continue. Hospice care, as a component of palliative care, prioritises quality of life and overall well being. Additionally, hospice support can be provided at any point during the patient's condition, not solely in its final stages. A combination of in-home and healthcare support, as well as inpatient care, is also available. Among women, lung cancer, followed by breast cancer, is the most reported cancer in hospice.
The quality of life in palliative care and hospice is vital, given the challenges faced by patients, caregivers, practitioners, families, and partners. It includes overall well being, covering physical, psychological, social, and spiritual aspects. Palliative care provides essential support when addressing the biopsychosocial components of quality of life. However, issues emerge when discussing sex. Despite recognition by organisations such as Marie Curie and Macmillan, there seems to be a reluctance to raise awareness or support research on this topic.
A range of psychosocial interventions is available for individuals after cancer treatment. An increasingly popular approach involves using mindfulness and mindful compassion to support psychosexual functioning. Mindful compassion has been utilised in psychosexual services, including various sexual issues 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 to illustrate how they can influence sexual arousal and enjoyment.
Research on mindfulness and mindful compassion for women after cancer treatments is limited and remains scarce among those in hospice end of life care. This is a sensitive but vital area, as sexual intimacy should not cease with a prognosis. The sense of connection to others is essential at the end of life, and this does not exclude sexual intimacy. This study aimed to assess the effectiveness of an online mindful compassion intervention, based on the 3 system model of emotions, among women with cancer and those receiving hospice care at home.
It was hypothesised that mindful compassion would improve sexual functioning, mindfulness, well-being, and quality of life among women following cancer treatment and in palliative care. Questionnaires were limited because the team did not want to overburden these women, as the focus was on the experience of brief mindful compassion.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, N7 8DB
- School of Social Sciences and Professions
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Were in hospice care with a cancer diagnosis/terminal
- We're receiving support and care
- Identified as female
- Registered with a healthcare service or charity
- Self-perceived satisfactory sexual intimacy before cancer diagnosis (Acquired)
- Aged 18 years or older
- Had a computer, laptop, mobile phone- intervention was online.
- Read and wrote English, as the intervention was delivered in English
- Patient Health Questionnaire 9 screening (score range from minimal to moderate, 0-14).
- Mental Capacity Mini Cog outcomes 3,4,5 (cognitive comprehension)
Exclusion Criteria:
- Were not in hospice care with a cancer diagnosis/terminal
- Did not identify as female
- Were very late-stage palliative/hospice care in which capacity (medication) may be compromised, or discomfort is experienced
- Were aged below 18 years old
- Had reading and writing difficulties in English
- Had a moderate to severe to high Patient Health Questionnaire 9 screening score (ranging from moderate to severe 15-27).
- Mental Capacity Mini Cog outcomes 0,1,2 (problematic cognitive comprehension)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active group
Mindful compassion group provided over 4 weeks
|
Participants were encouraged to engage in at home exercises, including breathing exercises, diaries for sexual desire and fantasies, and mindfulness and self-compassion practices such as working on body image.
This approach was guided by the 3 system model of emotions, where focusing on the mind and body helps identify physiological changes related to a perceived threat, cognitively recognising and attending to internal and external triggers, and incorporating mindful acceptance and compassion to address the critical inner voice.
These techniques will be applied both to daily life and sexual intimacy.
|
|
Active Comparator: Delayed group
Mindful compassion group commences at week 4 when the active group intervention terminates.
|
Participants were encouraged to engage in at home exercises, including breathing exercises, diaries for sexual desire and fantasies, and mindfulness and self-compassion practices such as working on body image.
This approach was guided by the 3 system model of emotions, where focusing on the mind and body helps identify physiological changes related to a perceived threat, cognitively recognising and attending to internal and external triggers, and incorporating mindful acceptance and compassion to address the critical inner voice.
These techniques will be applied both to daily life and sexual intimacy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Female Sexual Function Index
Time Frame: 0, 4 and 12 weeks
|
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.
|
0, 4 and 12 weeks
|
|
The Short Warwick Edinburgh Mental Wellbeing Scale
Time Frame: 0, 4 and 12 weeks
|
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.
|
0, 4 and 12 weeks
|
|
Brief Quality of Life Scale
Time Frame: 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.
|
Weeks 0, 4 and 12
|
|
The Self compassion Scale
Time Frame: 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.
|
Weeks 0, 4 and 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samantha Banbury, London Metropolitan University
Publications and helpful links
General Publications
- Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
- Smith EJ, Palevsky S. Salt poisoning in a two-year-old child. Am J Emerg Med. 1990 Nov;8(6):571-2. doi: 10.1016/0735-6757(90)90183-z. No abstract available.
- Banbury S, Tharmalingam H, Lusher J, Erridge S, Chandler C. A Preliminary Investigation into the Use of Cannabis Suppositories and Online Mindful Compassion for Improving Sexual Function Among Women Following Gynaecological Cancer Treatment. Medicina (Kaunas). 2024 Dec 7;60(12):2020. doi: 10.3390/medicina60122020.
- Wislawski J, Kasperlik-Zaluska A, Bonicki W, Piotrowska B. [Microadenomas of the pituitary treated by a microsurgical method using the approach through the sphenoid sinus]. Pol Tyg Lek. 1987 Oct 5-12;42(40-41):1266-8. No abstract available. Polish.
- Brotto LA, Dunkley CR, Breckon E, Carter J, Brown C, Daniluk J, Miller D. Integrating Quantitative and Qualitative Methods to Evaluate an Online Psychoeducational Program for Sexual Difficulties in Colorectal and Gynecologic Cancer Survivors. J Sex Marital Ther. 2017 Oct 3;43(7):645-662. doi: 10.1080/0092623X.2016.1230805. Epub 2016 Sep 3.
- Davison SL. Hypoactive sexual desire disorder. Curr Opin Obstet Gynecol. 2012 Aug;24(4):215-20. doi: 10.1097/GCO.0b013e328355847e.
- Jurin T, Sostaric M, Jokic-Begic N, Lauri Korajlija A. mSexHealth: An Overview of Mobile Sexual Health Applications. J Sex Marital Ther. 2023;49(2):129-140. doi: 10.1080/0092623X.2022.2079576. Epub 2022 Jun 2.
- Bagherzadeh R, Sohrabineghad R, Gharibi T, Mehboodi F, Vahedparast H. Effects of mindfulness-based stress reduction training on rumination in patients with breast cancer. BMC Womens Health. 2022 Dec 28;22(1):552. doi: 10.1186/s12905-022-02124-y.
- Borson S, Scanlan JM, Chen P, Ganguli M. The Mini-Cog as a screen for dementia: validation in a population-based sample. J Am Geriatr Soc. 2003 Oct;51(10):1451-4. doi: 10.1046/j.1532-5415.2003.51465.x.
- Sears C, Millman R, Brotto LA, Walker LM. Feasibility and Acceptability of a Group-Based Mindfulness Intervention for Sexual Interest/Arousal Disorder Following Breast Cancer Treatment. J Sex Marital Ther. 2023;49(5):533-549. doi: 10.1080/0092623X.2022.2154296. Epub 2022 Dec 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LondonsMU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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