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Trial registered on ANZCTR


Registration number
ACTRN12618001751268
Ethics application status
Approved
Date submitted
11/10/2018
Date registered
24/10/2018
Date last updated
24/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Meaning and Purpose (MaP) Therapy in Patients with Advanced Cancer: A Randomised Controlled Trial targeting psychological wellbeing
Scientific title
Meaning and Purpose (MaP) Therapy in Advanced Cancer Patients:
A Randomised Controlled Trial targeting psychological wellbeing
Secondary ID [1] 296409 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MaPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced cancer 310033 0
Distress 310034 0
Demoralization 310098 0
Condition category
Condition code
Cancer 308784 308784 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 x 1-hour weekly sessions of the manualised Meaning and Purpose Therapy delivered by a mental health clinician in the clinic in face to face sessions in addition to usual care. The counselling seeks to understand who each person is, review sources of meaning, potential directions with new goals, the meaning that can be derived from relating to others, any new priorities, choices or ways of appreciating life, so that life is lived with renewed purpose, commitment and value. The mental health clinician could be a psychologist, social worker or psychiatrist who has been specifically trained to deliver this model of therapy. Sessions are audio-recorded so that the clinician's adherence to the intervention can be checked for fidelity to the manualised model of intervention. No physical material is used in this study. The mental health clinician delivering the intervention will provide homework sheets to the patient at the conclusion of each session to guide the patient's preparation for the next session. Clinician's will monitor attendance on a study checklist.
Intervention code [1] 312651 0
Treatment: Other
Intervention code [2] 312652 0
Lifestyle
Intervention code [3] 312653 0
Behaviour
Comparator / control treatment
Usual oncological care is prescribed by the patient's treating oncologist or other physicians involved in the patient's care. There are no specific guidelines that guide this, as the study does not focus on a particular cancer. The patient will complete a demographic form that describes their basic social details and types of medical treatment received in broad terms. The study assumes that this oncological care will always be chosen by the oncologist and patient to be in the best interests of the patient. The medical record will be checked to confirm accuracy of this information.
Control group
Active

Outcomes
Primary outcome [1] 307766 0
Post Traumatic Growth Inventory; subscales of appreciation of life and new possibilities
Timepoint [1] 307766 0
3 months post intervention
Secondary outcome [1] 352812 0
Life Attitudes (LAP-R) (subscales of choice and goal seeking),
Timepoint [1] 352812 0
3 months post intervention
Secondary outcome [2] 353030 0
FACIT-SP Spiritual wellbeing
Timepoint [2] 353030 0
3 months post intervention
Secondary outcome [3] 353031 0
McGill Existential Quality of Life (existential wellbeing and quality f life)
Timepoint [3] 353031 0
3 months post intervention
Secondary outcome [4] 353032 0
DS-II (Demoralization)
Timepoint [4] 353032 0
3 months post intervention
Secondary outcome [5] 353033 0
PHQ-9 (depression)
Timepoint [5] 353033 0
3 months post intervention
Secondary outcome [6] 353034 0
DADDS (Death and dying distress scale)
Timepoint [6] 353034 0
3 month post intervention

Eligibility
Key inclusion criteria
• aged 18 years or older; No upper age limit
• advanced cancer with a prognosis of 2 years or less;
• Distress Thermometer score greater tan or equal to 4
• fluent in spoken and written English; and
• ability to give written informed consent
• willingness to participate in and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• known cognitive impairment that would interfere with participation;
• too unwell or frail (e.g., impairment associated with co-morbid conditions) to participate as determined by treating clinicians.

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)
Following completion of baseline measures, eligible participants will be randomised on a 1:1 ratio to one of the two conditions using central randomisation by phone/fax/computer, and stratified by level of distress between DT 4-6 and DT 7-10 and by sites. In addition to this initial blinding of participants, staff involved in the recruitment process will also be blinded to group allocation until randomisation occurs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A technique of concealed block allocations will be used
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention to treat analysis will be employed. Outcome differences between the 2 trial arms at post-intervention and 3 months follow-up will be tested with analysis of covariance, controlling for baseline scores. Impact of missing data will be assessed through complete case analysis and multiple imputations. Per protocol analysis will also be conducted. To test for group differences over time from baseline to 3-month follow up, linear mixed effects modelling will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2019
Actual
Date of last participant enrolment
Anticipated
10/01/2022
Actual
Date of last data collection
Anticipated
11/04/2022
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 12160 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [2] 12161 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 24329 0
3144 - Malvern
Recruitment postcode(s) [2] 24330 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 300918 0
Charities/Societies/Foundations
Name [1] 300918 0
Cabrini Foundation
Country [1] 300918 0
Australia
Funding source category [2] 300922 0
Charities/Societies/Foundations
Name [2] 300922 0
Cunningham Centre for Palliative Care
Country [2] 300922 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia
Address
160 Oxford Street, Darlinghurst, NSW, 2010
Country
Australia
Secondary sponsor category [1] 300483 0
None
Name [1] 300483 0
Monash University
Address [1] 300483 0
Wellington Road, Clayton VIC 3800
Country [1] 300483 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301692 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 301692 0
Ethics committee country [1] 301692 0
Australia
Date submitted for ethics approval [1] 301692 0
02/10/2018
Approval date [1] 301692 0
23/10/2018
Ethics approval number [1] 301692 0
Cabrini Human Research Ethics ID 15-17-09-18

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3167 3167 0 0
/AnzctrAttachments/376183-Protocol_Template_MaP Therapy.doc (Protocol)

Contacts
Principal investigator
Name 87790 0
Prof David Kissane
Address 87790 0
Cabrini Health, Haematology and Oncology Centre, Level 2, Area E, 183 Wattletree Road, Malvern, VIC, 3144
Country 87790 0
Australia
Phone 87790 0
+61 427011168
Fax 87790 0
Email 87790 0
david.kissane@nd.edu.au
Contact person for public queries
Name 87791 0
David Kissane
Address 87791 0
Cabrini Health, Haematology and Oncology Centre, Level 2, Area E, 183 Wattletree Road, Malvern, VIC, 3144
Country 87791 0
Australia
Phone 87791 0
+61 427011168
Fax 87791 0
Email 87791 0
david.kissane@nd.edu.au
Contact person for scientific queries
Name 87792 0
David Kissane
Address 87792 0
Cabrini Health, Haematology and Oncology Centre, Level 2, Area E, 183 Wattletree Road, Malvern, VIC, 3144
Country 87792 0
Australia
Phone 87792 0
+61 427011168
Fax 87792 0
Email 87792 0
david.kissane@nd.edu.au

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.