Effects of a Second-generation Mindfulness-based Intervention on Quality of Life, Pain Management, and Psycho-spiritual Wellbeing in Cancer Patients: A Randomised Controlled Trial

NCT06695234 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-11-19

No results posted yet for this study

Summary

Background This study explores the effectiveness of Meditation Awareness Training (MAT), a second-generation mindfulness-based intervention, in enhancing quality of life, pain management, and psycho-spiritual wellbeing among cancer patients. Existing research underscores the benefits of mindfulness-based interventions (MBIs) in alleviating psychological distress and improving overall quality of life for cancer patients. However, first-generation MBIs often exclude traditional Buddhist concepts such as impermanence and emptiness, Consequently, this can result in a superficial application that may not fully engage with the underlying causes of psychological distress or promote long-term spiritual and psychological growth.

In contrast, second-generation MBIs like MAT aim to reintegrate these wisdom principles, potentially offering deeper psycho-spiritual benefits. By incorporating concepts like impermanence and emptiness, these interventions encourage a more holistic understanding and acceptance of life's challenges, fostering meaningful perspectives on illness and enhancing both spiritual and psychological wellbeing. This approach seeks to provide a more comprehensive and transformative experience for individuals, particularly those facing serious health challenges such as cancer.

Aims

The primary aim is to understand the effectiveness of MAT in individuals diagnosed with cancer. The study focuses on:

Evaluating the impact of MAT on reducing psychological distress and enhancing pain management and quality of life.

Exploring whether practising Buddhist wisdom concepts can foster meaningful perspectives on illness and life, thereby increasing spiritual wellbeing.

Determining if MAT participation leads to the establishment of new daily practices and habits among cancer patients.

Method

The study employs a mixed-methods approach across three phases:

Phase 1: A quantitative study using a randomised controlled trial (RCT) design. Participants will be divided into an intervention group (MAT) and a treatment-as-usual (TAU) control group. The effectiveness of MAT will be assessed using psychometric scales at multiple time points (baseline, week 4, week 9 post-intervention, and six-month follow-up). Importantly, participants in the TAU group will be offered the MAT intervention after the completion of the RCT, ensuring that all participants have access to the potential benefits of the intervention.

Phase 2: A qualitative exploration using Interpretative Phenomenological Analysis (IPA) to gain insights into participants' lived experiences post-MAT intervention. This phase involves semi-structured interviews conducted at one month and six months post-intervention.

Phase 3: A content analysis of diary entries collected from participants during the intervention to capture real-time reflections and experiences.

Expected Outputs The study aims to provide empirical evidence on the effectiveness of MAT in improving psychological and spiritual wellbeing among cancer patients. It is expected to offer insights into how Buddhist wisdom can be integrated back into clinical mindfulness practices to enhance their impact. The findings could inform clinical practices and contribute to the development of more holistic mindfulness-based interventions for cancer care.

Project Timelines Recruitment: Began in November 2024. Phase 1: The RCT is aimed to begin in the first quarter of 2025, with the intervention lasting 8 weeks, followed by data collection at specified time points.

Phase 2: Conduct interviews at one month and six months post-intervention. Phase 3: Collect and analyse diary entries throughout the 8-week intervention. The entire study is structured to ensure comprehensive data collection and analysis, allowing for both quantitative and qualitative insights into the MAT intervention's impact on cancer patients.

Conditions

  • Cancer
  • Mindfulness-based Intervention
  • Meditation
  • Psychological Well-Being
  • Spiritual Wellbeing

Interventions

BEHAVIORAL

Meditation Awareness Training

A second-generation mindfulness-based intervention that reincorporates Buddhist wisdom concepts into mindfulness-based intervention.

Sponsors & Collaborators

  • University of Derby

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT06695234 on ClinicalTrials.gov