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Trial registered on ANZCTR


Registration number
ACTRN12620001165976
Ethics application status
Approved
Date submitted
8/09/2020
Date registered
6/11/2020
Date last updated
6/11/2020
Date data sharing statement initially provided
6/11/2020
Date results information initially provided
6/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Self-Help Manual for Distress and Quality of Life in the Acute Period of a Haemopoetic Stem Cell Transplant.
Scientific title
The Impact of a Self-Help Manual for Distress and Quality of Life in the Acute Phase of a Haemopoietic Stem Cell Transplant: An Effectiveness and Acceptability Pilot Study.
Secondary ID [1] 302265 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemopoietic Stem Cell Transplantation 318987 0
Emotional Distress 319356 0
Condition category
Condition code
Blood 316959 316959 0 0
Haematological diseases
Mental Health 317313 317313 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manual group participants received, in addition to TAU, a self-help manual integrated with a tailored 60-minute counselling session pre-transplant. The manual was developed by LK (Clinical Psychologist) and SDB (Social Worker) following a review of the literature, existing cancer psychosocial education fact sheets, other available self-help manuals presenting evidence-based approaches to self-management of psychosocial issues in cancer, and drawing on clinical experience on what was helpful in supporting patients undergoing HSCT. Content was also adapted from a longer self-help manual for breast cancer patients with permission from the author who also read and provided feedback on our manual before this was finalised.

The manual covers the following content (with no specific modules to be completed by patients): adjustment and coping, coping strategies, managing hospital stay and physical symptoms of distress/stress, mindful coping with symptoms and side-effects, using your support network, thoughts and feelings and problem solving, common problems for transplant patients, goal setting and recovery stories from transplant survivors.

The 60-minute pre-transplant introduction was utilised to build familiarity with the material, explore current knowledge of emotions and how cancer can impact, current stressors, and facilitate practice of manual strategies (e.g. relaxation/visualisation) to help manage emotional distress. A booster session of up to 30 minutes was given at 2-3-weeks post-transplant after completion of study measures. Participants had access to the manual for the entirety of the study (pre-transplant to 3-months post-transplant), with patients working through the manual at their own pace following the introductory session.

At 3-months post-transplant, participants were asked to complete a 13-item questionnaire asking via rated items or open-ended questions about their access to psychosocial support and use of the manual. To quantify manual use, participants rated: how much was read using a scale of 0-100%; hours/week spent using the manual; suggestions and set exercises completed (using a scale of None, 1-3, 4-6, 7-9, 10+); extent to which they had discussed content with others (rated using: Not at all, A little, A moderate amount, A lot); and helpfulness of the manual (using a scale of 0 = Not at all; 3 = Very). Participants were also asked four open-ended questions: “If you did not use the book, what were the barriers to using it?”; “what in particular did you find useful about the book”; What if any were the difficulties you had in using the book?”; and “What information would you have liked covered that was not in the book?”.
Intervention code [1] 318552 0
Prevention
Intervention code [2] 318792 0
Behaviour
Comparator / control treatment
Treatment as usual involved care provided by a multidisciplinary medical team and included access to social work and psychology for emotional support as per standard Alfred Health care for HSCT patients.
Control group
Active

Outcomes
Primary outcome [1] 325060 0
The Functional Assessment of Cancer Therapy-Bone Marrow Transplantation Version 4 (FACT-BMT) was used to measure Quality of Life. The FACT-BMT is a 50-item self-report scale asking about the past 7 days that assesses 5 dimensions of QoL: physical wellbeing, social wellbeing, emotional wellbeing, functional wellbeing and BMT-specific concerns. Items are measured using a 5-point Likert scale (0 = not at all; 4 = very much) and summed to create four wellbeing subscales (each with a range of 0-28), a BMTS subscale (0-40) and an overall QoL FACT-BMT score (0-148).
Timepoint [1] 325060 0
Pre-transplant, 2-3 weeks post-transplant and 3-months post-transplant.
Primary outcome [2] 325061 0
Psychological distress was measured via the 18-item self-report Brief Symptom Inventory. The BSI-18 measures distress caused by depressive (e.g. “Feeling lonely”), anxiety (e.g. “Spells of terror or panic”) and somatic (e.g. “Trouble getting your breath”) symptoms. Items are scored using a 5-point Likert scale (0 = not at all; 4 = extremely) and higher scores indicate greater distress. Normative-adjusted T-scores are generated for the three subscales (depressive, anxiety and somatic) and a summed Global Severity Index, with scores of >62 implying clinically meaningful distress.
Timepoint [2] 325061 0
Pre-transplant, 2-3 weeks post-transplant and 3-months post-transplant.
Secondary outcome [1] 386719 0
At 3-months post-transplant, participants were asked to complete a 13-item questionnaire asking via rated items or open-ended questions about their access to psychosocial support and, if relevant, the use of the manual. To quantify manual use, participants rated: how much was read using a scale of 0-100%; hours/week spent using the manual; suggestions and set exercises completed (using a scale of None, 1-3, 4-6, 7-9, 10+); extent to which they had discussed content with others (rated using: Not at all, A little, A moderate amount, A lot); and helpfulness of the manual (using a scale of 0 = Not at all; 3 = Very). Participants were also asked four open-ended questions: “If you did not use the book, what were the barriers to using it?”; “what in particular did you find useful about the book”; What if any were the difficulties you had in using the book?”; and “What information would you have liked covered that was not in the book?”.
Timepoint [1] 386719 0
3-months post-transplant

Eligibility
Key inclusion criteria
Adult recipients of autologous or allogeneic HSCT at a metropolitan hospital in Melbourne, Australia.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-english speaking, younger than 18 years of age and not capable of individually providing informed consent to participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A researcher not involved in recruitment or intervention delivery generated the schedule and prepared envelopes to inform the recruiting researcher of consenting participants group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomised 1:1 to receive either a self-help manual intervention in addition to TAU or TAU alone. The randomisation schedule was generated via a random number generator for blocks of 20 participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17460 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 31191 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 306685 0
Hospital
Name [1] 306685 0
The Alfred
Address [1] 306685 0
55 Commercial Rd, Melbourne VIC 3004
Country [1] 306685 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
55 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 307237 0
None
Name [1] 307237 0
Address [1] 307237 0
Country [1] 307237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306862 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 306862 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 306862 0
Australia
Date submitted for ethics approval [1] 306862 0
30/11/2015
Approval date [1] 306862 0
18/03/2016
Ethics approval number [1] 306862 0
465/15

Summary
Brief summary
The purpose of this project is to examine the effectiveness of a self-help manual intervention compared to treatment as usual for reducing emotional distress, increasing effective coping and improving quality of life in patients undergoing a stem cell or bone marrow transplant.

Previous experience has shown that this type of transplant is an intensive procedure that is physically and emotionally challenging, and many people undergoing a transplant experience significant emotional distress (ie. anxiety or depression). This can make it more difficult to cope with the treatment, and return to normal activities after treatment which may affect work, social and recreational interests.
Providing people with education about emotional distress and strategies to better manage it, has been shown to improve the ability to cope with physical and emotional distress.

It was hypothesised that a self-help manual intervention in addition to TAU will lead to reduced psychological distress and improved QoL at 2-3 weeks and 3-months post-HSCT compared with TAU alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105270 0
Ms Lynda Katona
Address 105270 0
The Alfred, 55 Commercial Rd, Melbourne VIC 3004
Country 105270 0
Australia
Phone 105270 0
+61 402 071 138
Fax 105270 0
Email 105270 0
L.Katona@alfred.org.au
Contact person for public queries
Name 105271 0
Mr Richard Lawrence
Address 105271 0
Monash University, Wellington Road, Clayton, VIC 3068
Country 105271 0
Australia
Phone 105271 0
+61 437 070 494
Fax 105271 0
Email 105271 0
richard.lawrence@monash.edu
Contact person for scientific queries
Name 105272 0
Mr Richard Lawrence
Address 105272 0
Monash University, Wellington Road, Clayton, VIC 3068
Country 105272 0
Australia
Phone 105272 0
+61 437 070 494
Fax 105272 0
Email 105272 0
richard.lawrence@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary