Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000238774
Ethics application status
Approved
Date submitted
26/02/2013
Date registered
27/02/2013
Date last updated
14/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Managing chemotherapy related distress
Scientific title
Comparing brief mindfulness with standard relaxation therapy on reducing distress and avoidance behaviour in cancer patients undergoing chemotherapy
Secondary ID [1] 281581 0
Nil known
Universal Trial Number (UTN)
U111-1137-2211
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy related distress 288464 0
Condition category
Condition code
Cancer 288224 288224 0 0
Any cancer
Mental Health 288834 288834 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness-based intervention in which participants will attend a total of three group sessions of 90 minutes duration, conducted once a week for three weeks. These group sessions will be facilitated by a psychologist and will be conducted alongside chemotherapy.
Intervention code [1] 286596 0
Treatment: Other
Intervention code [2] 286625 0
Behaviour
Comparator / control treatment
Active control of physical relaxation groups in which participants attend a total of three group sessions of 90 minutes duration, conducted once a week for three weeks. These relaxation sessions will be facilitated by a psychologist, conducted alongside chemotherapy, and will utilise standard relaxation exercises such as progressive muscle relaxation.
Control group
Active

Outcomes
Primary outcome [1] 288947 0
Mean distress thermometer scores
Timepoint [1] 288947 0
Baseline, at completion of intervention and 3 months after intervention is completed
Primary outcome [2] 288948 0
Mean Impact Events Scale - Modified for Cancer (IES) scores
Timepoint [2] 288948 0
Baseline, at completion of intervention and 3 months after intervention is completed
Primary outcome [3] 288949 0
Mean Memorial Symptom Assessment (MSAS-SF) scores
Timepoint [3] 288949 0
Baseline, at completion of intervention and 3 months after intervention is completed
Secondary outcome [1] 301415 0
Mean General Adherence Scale scores
Timepoint [1] 301415 0
Baseline, at completion of intervention and 3 months after intervention is completed
Secondary outcome [2] 301416 0
Mean Functional Assessment of Cancer Therapy Scale (FACT-G)
Timepoint [2] 301416 0
Baseline, at completion of intervention and 3 months after intervention is completed
Secondary outcome [3] 301417 0
Mean Five Facet Mindfulness Questionnaire (FFMQ) scores
Timepoint [3] 301417 0
Baseline, at completion of intervention and 3 months after intervention is completed
Secondary outcome [4] 301418 0
Mean Disgust Scale (DS-R) scores
Timepoint [4] 301418 0
Baseline, at completion of intervention and 3 months after intervention is completed
Secondary outcome [5] 301419 0
Mean Sexual Adjustment Questionnaire (SAQ) Scores
Timepoint [5] 301419 0
Baseline, at completion of intervention and 3 months after intervention is completed
Secondary outcome [6] 301420 0
Mean Modified Outcomes Study Social Support Scale (mMOS-SS) scores
Timepoint [6] 301420 0
Baseline, at completion of intervention and 3 months after intervention is completed

Eligibility
Key inclusion criteria
Those receiving adjuvant chemotherapy and first line treatment for metastatic disease over the age of 18. Participants must also be English-speaking.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-english speaking
Under 18

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person who will determine eligibility to this trial will be unaware of allocation to group, as the allocation decision will be made after participants have been enrolled in the study. Allocation will be concealed by randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using mixed model MANOVA to test for differences between control and experimental conditions in levels of mindfulness. Second, to investigate whether components of mindfulness predict levels of distress and avoidance behaviours, general linear model analyses will be conducted. Thirdly, to determine whether mindfulness moderates the relationship between distress and avoidance behaviours, logistic regressions will be conducted, with possible demographic confounds (age and sex) entered in the first step, measures of distress and/or avoidance behaviours, entered in the second, mindfulness entered in the third step, and finally interactions between standardised distress, avoidance and/or mindfulness components in the final step, allowing a test of whether mindfulness components moderate the link between the distress and avoidance behaviours in cancer patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/03/2013
Actual
18/03/2013
Date of last participant enrolment
Anticipated
Actual
20/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 4883 0
New Zealand
State/province [1] 4883 0
Auckland

Funding & Sponsors
Funding source category [1] 286793 0
University
Name [1] 286793 0
This trial is being conducted as part of Lisa Reynolds' doctoral study and as such is supported by the doctoral scholarship (University of Auckland Senior Health Research Scholarship) and university doctoral PReSS account that supports Ms Reynolds to conduct this research.
Country [1] 286793 0
New Zealand
Primary sponsor type
Individual
Name
Lisa Reynolds
Address
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 285584 0
Individual
Name [1] 285584 0
Associate Professor Nathan Consedine
Address [1] 285584 0
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142, New Zealand
Country [1] 285584 0
New Zealand
Secondary sponsor category [2] 285595 0
Individual
Name [2] 285595 0
Associate Professor Ian Bissett
Address [2] 285595 0
The University of Auckland
Department of Surgery
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142, New Zealand
Country [2] 285595 0
New Zealand
Other collaborator category [1] 277305 0
Individual
Name [1] 277305 0
Dr David Porter
Address [1] 277305 0
Medical Oncology Department
Regional Cancer and Blood Service
Building 7
Auckland City Hospital
Private Bag 92024
Auckland 1142, New Zealand
Country [1] 277305 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288860 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 288860 0
Ministry of Health
1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 288860 0
New Zealand
Date submitted for ethics approval [1] 288860 0
14/02/2013
Approval date [1] 288860 0
27/02/2013
Ethics approval number [1] 288860 0
12/NTB/75

Summary
Brief summary
This study is a randomised controlled trial comparing mindfulness-based therapy with standard physical relaxation in people who have had a diagnosis of cancer and who are undertaking first line chemotherapy as part of their treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34978 0
Ms Lisa Reynolds
Address 34978 0
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142, New Zealand
Country 34978 0
New Zealand
Phone 34978 0
+64 9 373 7599 x 84938
Fax 34978 0
Email 34978 0
[email protected]
Contact person for public queries
Name 18225 0
Ms Lisa Reynolds
Address 18225 0
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142, New Zealand
Country 18225 0
New Zealand
Phone 18225 0
+64 9 373 7599 x 84938
Fax 18225 0
Email 18225 0
[email protected]
Contact person for scientific queries
Name 9153 0
Ms Lisa Reynolds
Address 9153 0
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142, New Zealand
Country 9153 0
New Zealand
Phone 9153 0
+64 9 373 7599 x 84938
Fax 9153 0
Email 9153 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.