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Sexual Function DisturbancesNCT07296796

The Impact of Mindful Compassion on Sexual Functioning and Quality of Life in Home Hospice Care

A study testing Mindful compassion in people with Sexual Function Disturbances and End of Life, run by London Metropolitan University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 100 years, women only
What is being tested?
Mindful compassion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited Kingdom
Study dates
8 Aug 2023to 1 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • School of Social Sciences and Professions

    London, N7 8DB

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Mindful compassion
Medical subject headings
Sexual Dysfunctions, Psychological, Death, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful compassionBehavioural

    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.

Study groups in NCT07296796
Study groupRoleWhat they receive
Active groupExperimentalMindful compassion group provided over 4 weeks
Receives: Behavioral: Mindful compassion
Delayed groupActive comparatorMindful compassion group commences at week 4 when the active group intervention terminates.
Receives: Behavioral: Mindful compassion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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. 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.

    Measured: 0, 4 and 12 weeks

  2. 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. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing.

    Measured: 0, 4 and 12 weeks

  3. Brief Quality of Life Scale

    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.

    Measured: Weeks 0, 4 and 12

  4. The 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 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.

    Measured: Weeks 0, 4 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2025
  2. Study start8 Aug 2023
  3. Primary completion8 Aug 2025
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Waitlist controlled study with an active and delayed group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07296796
Sponsor's protocol ID
LondonsMU
Status last verified
Dec 2025
First submitted
25 Nov 2025
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 3438201
  • 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.

    PubMed 27592509
  • Davison SL. Hypoactive sexual desire disorder. Curr Opin Obstet Gynecol. 2012 Aug;24(4):215-20. doi: 10.1097/GCO.0b013e328355847e.

    PubMed 22729093
  • 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.

    PubMed 35652779
  • 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.

    PubMed 39768900
  • 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.

    PubMed 36575482
  • 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.

    PubMed 14511167
  • 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.

    PubMed 36573823
  • 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.

    PubMed 2222612
  • 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.

    PubMed 10782451

Questions about this trial

What is this clinical trial studying?

A study testing Mindful compassion in people with Sexual Function Disturbances and End of Life, run by London Metropolitan University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Female Sexual Function Index (time frame: 0, 4 and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07296796, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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