The Impact of Mindful Compassion on Sexual Functioning Post Breast Cancer Treatment

NCT06046716 | Completed

• 1 other identifier: LMU
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Functioning

Keywords

cancer; cancer treatment; wellbeing; sexual self efficacy; quality of life

Outcome Measures

Primary Outcomes (6)

• Patients Health Questionnaire

  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.

  This is taken at week 0

• 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.

  Weeks 0, 4 and 12

• Adapted Sexual Self-efficacy Erectile Tool

  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.

  Weeks 0, 4 and 12

• 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.

  Weeks 0, 4 and 12

• The Brunnsviken 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)

Experimental mindful compassion group

EXPERIMENTAL

Experimental randomised controlled waitlist study The experimental group (n=28) will receive mindful compassion intervention at week 1 and intervention terminates at week 4

Behavioral: Mindful compassion based on behavioural change taxonomy experimental group

Waitlist mindful compassion control group

OTHER

Experimental randomised controlled waitlist study The delayed group (n=24) will receive mindful compassion intervention at week 4 and intervention terminates at week 8

Behavioral: Mindful compassion based on behavioural change taxonomy experimental group

Interventions

Mindful compassion based on behavioural change taxonomy experimental group BEHAVIORAL

Since this is a waitlist control study both groups get the same intervention. This is a mindful compassion intervention which is based on the behavioural change taxonomy techniques to support the reliability of the intervention. This will include sensate, mindful exercises, relaxation and attending to the critical voice. The intervention consists of behavioural, cognitive and mindful compassion constructs.

Experimental mindful compassion group; Waitlist mindful compassion control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Only women participated in this study post breast cancer treatment
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Metropolitan University: lead

Study Sites (1)

London Met university

London, N7 8DB, United Kingdom

Location

Related Publications (11)

• Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.

  PMID: 23512568 RESULT

• Libman E, Rothenberg I, Fichten CS, Amsel R. The SSES-E: a measure of sexual self-efficacy in erectile functioning. J Sex Marital Ther. 1985 Winter;11(4):233-47. doi: 10.1080/00926238508405450.

  PMID: 4078907 RESULT

• Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

  PMID: 18042300 RESULT

• Spector IP, Carey MP, Steinberg L. The sexual desire inventory: development, factor structure, and evidence of reliability. J Sex Marital Ther. 1996 Fall;22(3):175-90. doi: 10.1080/00926239608414655.

  PMID: 8880651 RESULT

• Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.

  PMID: 25462882 RESULT

• Feldman, G., Hayes, A., Kumar, S., Greeson, J., & Laurenceau, J. P. (2007). Mindfulness and emotion regulation: The development and initial validation of the Cognitive and Affective Mindfulness ScaleRevised (CAMS-R). Journal of Psychopathology and Behavioral Assessment, 29(3), 177-190

  RESULT

• Neff, K. D. (2003). Development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250.

  RESULT

• Vosper, J., Irons, C., Mackenzie-White, K., Saunders, F., Lewis, R., & Gibson, S. (2021). Introducing compassion focused psychosexual therapy. Sexual and Relationship Therapy, 1-33.

  RESULT

• Saunders, F., Vosper, J., Gibson, S., Jamieson, R., Zelin, J., & Barter, J. (2022). Compassion Focused Psychosexual Therapy for Women Who Experience Pain during Sex. OBM Integrative and Complementary Medicine, 7(2), 1-1.

  RESULT

• Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

  PMID: 21584907 RESULT

• 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.

  PMID: 10782451 RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

• Samantha Banbury, PhD

  London Metropolitan Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader

Model Details: Randomised control waitlist n=28 active experimental group and n=24 waitlist control delayed group

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: September 1, 2022
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)