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Trial registered on ANZCTR


Registration number
ACTRN12618001663246
Ethics application status
Approved
Date submitted
28/09/2018
Date registered
9/10/2018
Date last updated
21/04/2021
Date data sharing statement initially provided
16/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a 5-Session Cognitive Behaviour Therapy Intervention Improve Emotional Distress and Quality of Life for Allogeneic Hematopoietic Stem Cell Transplant Survivors?
Scientific title
Can a 5-Session Cognitive Behaviour Therapy Intervention Improve Emotional Distress and Quality of Life for Allogeneic Hematopoietic Stem Cell Transplant Survivors?
Secondary ID [1] 295982 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of Life in Allogeneic Bone Marrow Transplant Recipients 309493 0
Condition category
Condition code
Cancer 308325 308325 0 0
Leukaemia - Chronic leukaemia
Cancer 308326 308326 0 0
Leukaemia - Acute leukaemia
Cancer 308327 308327 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 308328 308328 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 308329 308329 0 0
Hodgkin's
Cancer 308330 308330 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behavioural Therapy (CBT) for Allogeneic Hematopoetic Stem-Cell Transplantation (HSCT) Survivors is an intervention designed to provide brief and focused psychotherapeutic CBT treatment for psychological distress and HRQoL through specifically targeting recipients’ mental adjustment and coping responses. The intervention will consists of face-to-face or telehealth delivered individual counselling sessions of 1 hour a week for 5 sessions with a psychology trainee within a Doctorate of Clinical Psychology program at Monash University. Content of these sessions is broadly focused on the following, Defining Values and Goals Setting, Understanding and Managing Your Emotions, Enhancing Personal Control and Mastery, Developing More Constructive Thinking, Changing Your Thinking. Homework is scheduled following each session of approximately 10 minutes a day. Homework following each session broadly consists of the following, Defining Values & Goals, Practising Deep Breathing, Engaging in Pleasurable Activities, and completing Dysfunctional Though Records. The intervention will be delivered at both The Alfred Hospital and The Peter MacCallum Cancer Centre.
Intervention code [1] 312309 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307305 0
Global subjective health related quality of life as measured by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant Scale Version 4.
Timepoint [1] 307305 0
Immediately pre-intervention and immediately post-intervention.
Secondary outcome [1] 351430 0
Global subjective psychological distress as measured by The Brief Symptom Inventory-18.
Timepoint [1] 351430 0
Immediately pre-intervention and immediately post-intervention.

Eligibility
Key inclusion criteria
Participants will be allogeneic HSCT recipients who are English speaking, over 18 years of age, and who are 3-12 months post-transplantation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Experiencing a delirium, currently receiving psychotherapeutic treatment or unable to individually provide full informed consent (due to intellectual disability, acute medical illness etc).

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)
Not group allocation, thus not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Repeated measures t-tests, bivariate Pearson correlations, mediation analysis and qualitative responses via a feedback questionnaire.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/12/2019
Actual
7/01/2020
Date of last participant enrolment
Anticipated
12/10/2020
Actual
20/10/2020
Date of last data collection
Anticipated
14/12/2020
Actual
3/02/2021
Sample size
Target
33
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11763 0
The Alfred - Prahran
Recruitment hospital [2] 11764 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 23858 0
3004 - Prahran
Recruitment postcode(s) [2] 23859 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 300577 0
University
Name [1] 300577 0
Monash University
Country [1] 300577 0
Australia
Primary sponsor type
Individual
Name
Peter Norton
Address
School of Psychological Sciences
Level 6, 18 Innovation Walk,
Monash University,
Wellington Road,
Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 300070 0
Individual
Name [1] 300070 0
Richard Lawrence
Address [1] 300070 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Road,
Melbourne VIC 3004
Country [1] 300070 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301366 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 301366 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 301366 0
Australia
Date submitted for ethics approval [1] 301366 0
08/11/2018
Approval date [1] 301366 0
17/12/2018
Ethics approval number [1] 301366 0
44526

Summary
Brief summary
The purpose of this study is to see if a 5 session psychological therapy program delivered after bone marrow transplantation can have a positive impact on quality of life and psychological distress in these patients.

Who is it for?
You may be eligible for this study if you are aged 18 or older and have received a bone marrow transplant in the last 3 to 12 months.

Study details
All participants in this study will receive 5 individual sessions of face-to-face cognitive behavioural therapy targeting mental adjustment and coping strategies. Participants will also need to do approximately 10 minutes of ‘homework’ every day following each of the first 4 sessions. As part of the study, participants will complete questionnaires about their quality of life, psychological distress, mental adjustment, coping and self-efficacy before and after the 5 session intervention. Participants will also be asked to complete questionnaires about their psychological distress and homework completion at each session.

It is hoped this research will provide evidence this program improves mental health outcomes in this patient population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86766 0
Mrs Lynda Katona
Address 86766 0
The Alfred, 55 Commercial Road, Melbourne VIC 3004
Country 86766 0
Australia
Phone 86766 0
+61 402 071 138
Fax 86766 0
Email 86766 0
[email protected]
Contact person for public queries
Name 86767 0
Richard Lawrence
Address 86767 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Road,
Melbourne VIC 3004
Country 86767 0
Australia
Phone 86767 0
+61 437070494
Fax 86767 0
Email 86767 0
[email protected]
Contact person for scientific queries
Name 86768 0
Richard Lawrence
Address 86768 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Road,
Melbourne VIC 3004
Country 86768 0
Australia
Phone 86768 0
+61437070494
Fax 86768 0
Email 86768 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Other researchers may request access to participants raw de-identified outcome data underlying research findings in the future for the purpose of further analysis. Their access to this data will require approval from the original research team as well as approval from a Human Research Ethics Committee at their home institution
When will data be available (start and end dates)?
At the completion of the project. Likely between 01/07/2020 - 01/07/2021.
Available to whom?
Only researchers who provide a methodologically sound proposal. Their access to this data will require approval from the original research team as well as approval from a Human Research Ethics Committee at their home institution
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Their access to this data will require approval from the original research team as well as approval from a Human Research Ethics Committee at their home institution.


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.