Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000647437
Ethics application status
Approved
Date submitted
11/05/2016
Date registered
18/05/2016
Date last updated
11/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness, acceptance and meaning of life for adults with advanced cancer.
Scientific title
Mindfulness training including acceptance and meaning of life for adults coping with advanced cancer: One-group pre-test post-test study with mixed methods approach.
Secondary ID [1] 289178 0
Nil known
Universal Trial Number (UTN)
U1111-1182-7972
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced cancer/stage III (as well as Stage IV). 298718 0
Condition category
Condition code
Cancer 298773 298773 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness therapeutic training.
20 - 30 minutes of a one-to-one session with the researcher occur once a week for four weeks. A digital recording containing the trainingwill be developed as an easy device for participants to keep and practice should they wish.
Sessions content:
Session 1 contains guided meditation ( breathing and relaxation techniques, the body scan) awareness, focus on the present moment and mindful coping skills.
Session 2 contains guided meditation ( breathing and relaxation techniques) and reflections about attitudes to acceptance through mindfulness practice.
Session 3 contains guided meditation ( breathing and relaxation techniques) and reflections about meaning in life through mindfulness practice.
Session 4 contains a closure involving mindfulness of breath and body sensations, mindfulness of thoughts and feelings, the practice review and reflections about meaning in life.
All sessions are 20 - 30 minutes in length.
The facilitator is a Psychology graduate trained in Mindfulness-Based Stress Reduction.
To monitor adherence a register of attendance at sessions will be conducted.
Intervention code [1] 294707 0
Treatment: Other
Comparator / control treatment
This is a single group pre-test and post-test study with no comparator treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298241 0
Meaning in life: concerning the participants' responses to the pre-intervention semi-structure qualitative interview regarding meaning in life.
Timepoint [1] 298241 0
Week 2 pre-intervention.
Primary outcome [2] 298345 0
Meaning in life: concerning the participants' responses to the post-intervention semi-structure qualitative interview regarding meaning in life.
Timepoint [2] 298345 0
Week 5 post-intervention.
Secondary outcome [1] 323648 0
Efficacy of the mindfulness training in improving patients’ mindful coping skills: assessed using the Mindful Coping Scale.
Timepoint [1] 323648 0
Week 2 pre-intervention and week 5 post-intervention.
Secondary outcome [2] 323841 0
Efficacy of the mindfulness training in improving patients’ attitudes to acceptance: assessed using the Acceptance Action Questionnaire-II
Timepoint [2] 323841 0
Week 2 pre-intervention and week 5 post-intervention.
Secondary outcome [3] 323842 0
Efficacy of the mindfulness training in encouraging patients’ reflections about their meaning in life: assessed using the Meaning of Life Questionnaire.
Timepoint [3] 323842 0
Week 2 pre-intervention and week 5 post-intervention.

Eligibility
Key inclusion criteria
Adults with a diagnosis of advanced cancer (stage III and stage IV), which is any type of cancer that cannot be cured and is life-threatening.
Non-Maori or Maori, age > 18 years old, no upper age limit. Have a clear understanding of written and spoken English and commitment to regular attendance to participate in the intervention program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently compromised breathing conditions, hospitalization, acute exacerbation or debilitating event, advanced level of neurological and auditory impairment, and or psychiatric disorders likely to affect the ability to participate in the intervention program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. This is a single group pre-test and post-test study with no control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample: 30 adults with advanced cancer who meet the inclusion criteria, will be invited to participate in this study by the Oncology Research Nurse coordinator from the Oncology department at the Christchurch Hospital.
Sample size calculation: The sample size has been set by the qualitative aspect of the study. The quantitative aspect is viewed as a ‘pilot’ study. The small sample size is acknowledged to unlikely to be able to find statistically significant differences on the primary outcome measure but is included to give establish effect sizes on this measure and therefore samples sizes needed for future research. A sample size of 30 participants could detect only a large effect size (.8 or above), with 80% power and a p-value of <0.05. Pilot studies by their nature, will not produce significant (i.e P<0.05) results (Arain et al., 2010).
As the aim of this study is to demonstrate intervention efficacy in a single group, a sample in the range of 20–25 will probably be adequate when population effect sizes are likely to be moderate or larger (Hertzog, 2008). A sample of 30 participants was established as adequate for this study, considering dropout rates and the possibility to go for a larger study in the future. For clinical trials of 80–250 participants, total pilot sample sizes of 20–40 would be adequate (Hertzog, 2008). This intervention study is grounded in the Mindfulness-Based Stress Reduction training, the traditional MBSR training is applied in group sessions with up to 30 participants and one or two instructors (Carlson, 2013)
Qualitative data will be collected using semi-structured pre and post-interview questionnaires and the quantitative data will be collected using three measurement instruments: Acceptance and Action Questionnaire-II (AAQ II), Mindful Coping Scale (MCS) adapted version and the Meaning of Life Questionnaire (MLQ). Paired t-tests will be used to assess the group improvement on all outcomes for each group after completing the four (4) weeks of intervention. Paired t-tests were chosen to compare the means of data from the two related samples with observations before and after the intervention on the same participants (McDonald, 2014). A SPSS version will be used.
The interviews will be audio recorded. Recordings will be transcribed word for word; analysis will begin immediately.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2016
Actual
9/01/2017
Date of last participant enrolment
Anticipated
14/08/2017
Actual
4/01/2018
Date of last data collection
Anticipated
Actual
8/02/2018
Sample size
Target
30
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 7869 0
New Zealand
State/province [1] 7869 0
Canterbury

Funding & Sponsors
Funding source category [1] 293564 0
University
Name [1] 293564 0
University of Otago - Christchurch.
Country [1] 293564 0
New Zealand
Primary sponsor type
Individual
Name
Primary supervisor, Dr Beverley Burrell.
Address
Centre for Postgraduate Nursing Studies - University of Otago.
72 Oxford Terrace, Level 3,
PO Box 4345,
Christchurch. 8140
Country
New Zealand
Secondary sponsor category [1] 292382 0
None
Name [1] 292382 0
Address [1] 292382 0
Country [1] 292382 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295008 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 295008 0
Ethics Department
Freyberg Building office
20 Aitken Street
Thorndon
Ground Floor, Reception
Wellington 6011
Ethics committee country [1] 295008 0
New Zealand
Date submitted for ethics approval [1] 295008 0
20/05/2016
Approval date [1] 295008 0
06/09/2016
Ethics approval number [1] 295008 0
ref. 16/NTA/75

Summary
Brief summary
Training individuals gravely ill in mindfulness practice can assist them in to become less reactive in the face of difficulties such as pain, the loss of capacities, managing relationships and facing death. This study aims to expand previous findings by using one-group pre-test post-test design to research the efficacy of a therapeutic intervention grounded on Mindfulness-Based Stress Reduction to help adults with advanced cancer to cope with their life-threatening illness. A further aim of this intervention study is to assess the value of assisting people with advanced cancer to think about and discuss their own meaning in life and acceptance of their current situation. This study design is one-group pre-test post-test with mixed methods approach. Data collection and analysis will be carried out on the basis of this methodology. A sample of 30 adults with advanced cancer who meet the inclusion criteria, will be invited to participate in this study by the Oncology Research Nurse coordinator from the Oncology department at the Christchurch Hospital. One 30 minutes’ session for 4 weeks will be conducted face-to-face with the researcher. As part of the intervention a digital audio recording containing the therapeutic intervention sessions, will be developed as an easy device for adults coping with advanced cancer. Participants will be asked to complete a small number of questionnaires and one interview once before and once after the 4 weeks of the therapeutic program, to find out changes in levels of mindful coping skills, attitudes to acceptance and reflections about meaning in life. Data analysis will commence during the data collection and after carrying out the study. Accordingly to the converged mixed methods design, qualitative and quantitative data will be analyzed separately, and then merged to investigate variances in mindful coping skills of the participants as well as acceptance attitude and meaning in life.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1666 1666 0 0
/AnzctrAttachments/370673-HDEC Approval letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 65750 0
Mrs Fernanda Fernandez Zimmermann
Address 65750 0
Centre for Postgraduate Nursing Studies - University of Otago, Christchurch.
72 Oxford Terrace. Level 3,
PO Box 4345, Christchurch 8140
Country 65750 0
New Zealand
Phone 65750 0
+64 226419956
Fax 65750 0
Email 65750 0
fernanda.zimmermann@postgrad.otago.ac.nz
Contact person for public queries
Name 65751 0
Dr Beverley Burrell
Address 65751 0
Centre for Postgraduate Nursing Studies - University of Otago, Christchurch.
72 Oxford Terrace. Level 3,
PO Box 4345, Christchurch 8140
Country 65751 0
New Zealand
Phone 65751 0
+64 3643860
Fax 65751 0
Email 65751 0
beverley.burrell@otago.ac.nz
Contact person for scientific queries
Name 65752 0
Mrs Fernanda Fernandez Zimmermann
Address 65752 0
Centre for Postgraduate Nursing Studies - University of Otago, Christchurch.
72 Oxford Terrace. Level 3,
PO Box 4345, Christchurch 8140
Country 65752 0
New Zealand
Phone 65752 0
+64 226419956
Fax 65752 0
Email 65752 0
fernanda.zimmermann@postgrad.otago.ac.nz

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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