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

NCT07296796 | Completed DMC

• 1 other identifier: LondonsMU
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sexual Function Disturbances; End of Life; Quality of Life; Well-Being, Psychological

Outcome Measures

Primary Outcomes (4)

• 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.

  0, 4 and 12 weeks

• 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.

  0, 4 and 12 weeks

• 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.

  Weeks 0, 4 and 12

• 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.

  Weeks 0, 4 and 12

Study Arms (2)

Active group

EXPERIMENTAL

Mindful compassion group provided over 4 weeks

Behavioral: Mindful compassion

Delayed group

ACTIVE COMPARATOR

Mindful compassion group commences at week 4 when the active group intervention terminates.

Behavioral: Mindful compassion

Interventions

Mindful compassion BEHAVIORAL

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 group; Delayed group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Identify as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• London Metropolitan University: lead

Study Sites (1)

School of Social Sciences and Professions

London, N7 8DB, United Kingdom

Location

Related Publications (10)

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MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Death; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Samantha Banbury

  London Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Waitlist controlled study with an active and delayed group

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 22, 2025
• Study Start: August 8, 2023
• Primary Completion: August 8, 2025
• Study Completion: October 1, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)