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

NCT06046716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-05-23

No results posted yet for this study

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

Interventions

BEHAVIORAL

Mindful compassion based on behavioural change taxonomy experimental group

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.

Sponsors & Collaborators

  • London Metropolitan University

    lead OTHER

Principal Investigators

  • Samantha Banbury, PhD · London Metropolitan Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-09-13
Completion
2023-09-13

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06046716 on ClinicalTrials.gov