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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Derby

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be over the age of 18 and have received a cancer diagnosis, including any recurrences, within the last 24 months. Eligible diagnoses can range up to, but not exceed, stage 3 cancer at the start of the study.

Participants to be available to attend weekly 2-hour sessions for 8 weeks

Due to the nature of the online course, participants must have access to the Internet and use an electronic device capable of joining a video conference.

Disqualifiers

Those with a palliative diagnosis

Those who may not speak English fluently.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Meditation Awareness Training

    Behavioral

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: MAT RCT studyExperimental treatment 1 intervention
Group B: Qualitative follow-upNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Depression, Anxiety, Stress scale (DASS)

Assesses emotional states like depression, anxiety, and stress. 4-point likert scale with 0 'Does not apply to me at all' to 3 ' Applies all the time'. Higher total scores indicate higher levels of each sub category, anxiety, depression and stress.

Time frame
From enrolment, throughout the 8-week RCT, at 9 week follow up and at 6 months follow up
2

McGill Pain Questionnaire Short-form

Evaluates pain levels. Rates 15 pain descriptors on a scale of 0-3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the descriptors

Time frame
From enrolment, throughout the 8-week RCT, at 9 week follow up and at 6 months follow up
3

The Functional Assessment of Chronic Illness Therapy - Spiritual Well-being Scale (FACIT-Sp)

To measure spiritual wellbeing and overall quality of life.scored on a 5-point Likert scale, with 0 representing "not at all" and 4 representing "very much". Possible scores range from 0 to 48, with higher scores reflecting greater spiritual well-being and QOL.

Time frame
From enrolment, throughout the 8-week RCT, at 9 week follow up and at 6 months follow up

Secondary outcomes

1

Five Facet Mindfulness Questionnaire (FFMQ)

Used to measure mindfulness. The 39 items of the FFMQ are rated on a 5-point Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true).igher scores indicate greater mindfulness

Time frame
From enrolment, throughout the 8-week RCT, at 9 week follow up and at 6 months follow up

Other outcomes

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