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Trial registered on ANZCTR


Registration number
ACTRN12617000407392
Ethics application status
Approved
Date submitted
27/02/2017
Date registered
20/03/2017
Date last updated
12/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The psychosocial impact of haematopoietic stem cell donation on adult related donors
Scientific title
A multi-center, prospective, exploratory study of the psychosocial impact of donating haematopoietic stem cells on adult related donors
Secondary ID [1] 290716 0
None
Universal Trial Number (UTN)
U1111-1193-4236
Trial acronym
IMPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematopoietic stem cell donation 301284 0
Psychosocial distress 301286 0
Unmet needs 301287 0
Quality of life 301288 0
Condition category
Condition code
Public Health 301040 301040 0 0
Health service research
Blood 301041 301041 0 0
Haematological diseases
Mental Health 301042 301042 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
PHASE 1
Group 1 - adult related stem cell transplant donors
Adult related stem cell transplant donors of planned allogeneic transplant recipients will complete three semi-structured interviews and provide three samples of saliva (as a measure of stress) at the following time points:
(T1) Within 2 weeks before the stem cell mobilisation commences;
(T2) Within 24 hours (pre- or post-donation) of the donors’ stem cell collection and;
(T3) Within 2 weeks of the 30-day anniversary of the stem cell collection.

Group 2 - Adult related lymphocyte infusion donors
Adult related lymphocyte donors of planned lymphocyte infusions recipients are included in this study to consider any potential effect granulocyte colony-stimulating factor (GCSF) may have on salivary alpha-amylase levels. Related lymphocyte donors will provide three samples of saliva at the following time points:
(T1) Within 2 weeks before the lymphocyte collection;
(T2) Within 24 hours (pre- or post-donation) of the donors’ lymphocyte collection and;
(T3) Within 2 weeks of the 30-day anniversary of the lymphocyte collection

Group 3 - Bone Marrow Transplant Nurses
Bone Marrow Transplant Nurses will complete one interview towards the end of the study. The interview will explore the nature of their role, their perceptions of the psychosocial needs of donors and their role (if any) in responding to donor distress.

PHASE II
In response to the needs identified through interviews with adult related stem cell donors and nurses, a psycho-educational resource will be developed to improve donor efficacy and promote self-care. Adult related stem cell donors and Nurses from Phase I will be re-contacted and asked to evaluate the psychoeducational resource. A study pack including an information sheet, resource, questionnaire and reply paid envelope for returning the questionnaire will be mailed to potential participants. Consent is presumed by completion and return of the postal questionnaire in a reply paid envelope. Questionnaires will take approximately 20 minutes to complete.
Intervention code [1] 297352 0
Not applicable
Comparator / control treatment
Adult related lymphocyte infusion donors are included in this study to consider any potential effect of granulocyte-colony stimulating factor (GCSF) on salivary alpha-amylase levels. These patients are an appropriate control group since white cells are collected from these donors by apheresis in the absence of GCSF.
Control group
Active

Outcomes
Primary outcome [1] 300462 0
Phase I
Psychological distress will be measured using the Kessler Psychological Distress Scale (K10)
Timepoint [1] 300462 0
(1) 2 weeks pre-stem cell collection;
(2) on the day of stem cell collection;
(3) 30 days post-stem cell collection
Primary outcome [2] 301209 0
Phase I
Health-related quality of life will be measured using the World Health Organisation Quality of Life (WHOQOL-BREF); an abbreviated version of the WHOQOL-100.
Timepoint [2] 301209 0
(1) 2 weeks pre-stem cell collection;
(2) 30 days post-stem cell collection
Primary outcome [3] 301214 0
Phase I
Saliva will be collected using Salivettes and analysed for salivary alpha-amylase activity (biomarker for activity of the sympathetic nervous system) by a liquid handling platform (the Beckman Coulter AU-480).
Timepoint [3] 301214 0
(1) 2 weeks pre-stem cell collection;
(2) on the day of stem cell collection;
(3) 30 days post-stem cell collection
Secondary outcome [1] 330024 0
Phase I
Ambivalence about donation will be measured using the Ambivalence about Donation scale developed by Simmons et al., 1977.
Timepoint [1] 330024 0
2 weeks pre-stem cell collection
Secondary outcome [2] 332052 0
Phase I
Donation experience will be assessed using the Donation Experience scale developed by Butterworth et al., 1993. An overall score is not derived, but individual items are reviewed to understand the donation experience.
Timepoint [2] 332052 0
(1) on the day of stem cell collection;
(2) 30 days post-stem cell collection
Secondary outcome [3] 332053 0
Phase I
Guilt and responsibility will be assessed using the Guilt and Responsibility scale developed by Butterworth et al., 1993. The individual items are examined separately in the analyses.
Timepoint [3] 332053 0
(1) 2 weeks pre-stem cell collection;
(2) on the day of stem cell collection;
(3) 30 days post-stem cell collection
Secondary outcome [4] 332054 0
Phase I
Self esteem will be measured using the Better Person scale developed by Simmons et al., 1977
Timepoint [4] 332054 0
(1) 2 weeks pre-stem cell collection;
(2) on the day of stem cell collection;
(3) 30 days post-stem cell collection
Secondary outcome [5] 332285 0
Phase I
Donor-recipient contact will be assessed using a scale designed specifically for the study of (a) daily, (b) weekly, (c) monthly or (d) yearly/less frequent contact
Timepoint [5] 332285 0
(1) 2 weeks pre-stem cell collection;
(2) 30 days post-stem cell collection
Secondary outcome [6] 332286 0
Phase I
Relationship closeness with the recipient will be assessed using the Autonomy and Relatedness Inventory (ARI) scale
Timepoint [6] 332286 0
(1) 2 weeks pre-stem cell collection;
(2) 30 days post-stem cell collection
Secondary outcome [7] 332287 0
Phase I
Donors will rate their opinion of the recipient's health using the Karnofsky Performance Status (KPS) scale.
Timepoint [7] 332287 0
(1) 2 weeks pre-stem cell collection;
(2) on the day of stem cell collection;
(3) 30 days post-stem cell collection
Secondary outcome [8] 332289 0
Phase I
Qualitative questionnaire 1 - Adult related stem cell transplant donors of planned allogeneic transplant recipients. In addition to validated measures, a number of qualitative questions were designed specifically for the study to provide a full assessment of the deeper aspects of related donation and suggestions for improvement pre-donation: 1. Decision to donate/ Did you at all hesitate in deciding to donate? 2. What was your motivation to donate? I.e. why are you donating? 3. Did you at all feel pressured to donate? 4. What are your thoughts and feelings about being a donor? 5. How prepared do you feel for the donation experience? 6. What were some of the sources of information that you accessed prior to donation? Use a checklist of available sources: *Haematologist *Internet, incl. videos *BMT coordinator *Books *Friends/family *General practitioner 7. What was the most helpful source of information about donation? 8. How do you think the hospital can improve donor preparation?
Timepoint [8] 332289 0
2 weeks pre-stem cell collection
Secondary outcome [9] 332290 0
Phase 1
Qualitative questionnaire 2 - Adult related stem cell transplant donors of planned allogeneic transplant recipients. These qualitative questions explore the deeper aspects of related donation and any suggestions for improvement pre-donation and on the day of donation. 1. Sources of emotional support and use of emotional support services of the hospital? 2. Adequacy of emotional support from the hospital: *Not at all adequate *Moderately adequate *Adequate *Very adequate 3. How do you think the hospital can improve donor emotional support?
Timepoint [9] 332290 0
On the day of stem cell collection
Secondary outcome [10] 332291 0
Phase 1
Qualitative questionnaire 3 - Adult related stem cell transplant donors of planned allogeneic transplant recipients. These qualitative questions explore the deeper aspects of related donation and any suggestions for improvement post-donation. 1. Looking back, what are your thoughts and feelings about being a donor after donation? 2. Has donating changed your relationship with your recipient or other family members? 3. What was the most challenging aspect of donation?
Timepoint [10] 332291 0
30 days post-stem cell collection
Secondary outcome [11] 332796 0
Phase 1
Adult related stem cell transplant donor demographics assessed by a questionnaire designed specifically for this study. Participants are asked for their age, gender, country of birth, marital status, relationship to the recipient, and education.
Timepoint [11] 332796 0
2 weeks pre-stem cell collection
Secondary outcome [12] 332798 0
Phase I
BMT Nurse demographics (age, length of professional experience as nurses in Haematology/BMT Units and as BMT Coordinators) will be assessed by a questionnaire designed specifically for this study.
Timepoint [12] 332798 0
BMT Coordinator demographics will be assessed through one interview at a single timepoint.
Secondary outcome [13] 332879 0
Phase I
Organisation of related donor care in BMT Units will assessed by a questionnaire designed specifically for this study. Questions on donation procedures requested a description of each BMT unit’s organisation, including (1) information provided to potential donors (support materials and professionals involved); (2) HLA tests procedures; (3) the consent process; (4) the availability of financial support; and (5) donor follow- up.
Timepoint [13] 332879 0
Phase I
Organisation of related donor care in BMT Units will be assessed through one interview with BMT Nurse participants at a single timepoint
Secondary outcome [14] 332880 0
Phase I
BMT Nurse' perceptions of the related donation process will be assessed by a questionnaire designed specifically for this study. Open-ended questions invited BMT Nurses to give their opinion about the related donation process in terms of their own role, the challenges encountered in their professional experience, related donors' concerns and suggestions to improve the organisation of related donation.
Timepoint [14] 332880 0
Phase I
BMT Nurses' perceptions of the related donation process will be assessed through one interview at a single timepoint.
Secondary outcome [15] 352831 0
Phase II
Acceptability of the resource will be determined by participant evaluation of the acceptability, perceived usefulness and benefits of the resource. The items included in the questionnaires for completion by donors and Nurses will assess participant perceptions of the content, structure, design, timing and delivery of the resource.
Timepoint [15] 352831 0
Participant evaluation of the resource will be assess through completion and return of a postal questionnaire. A study pack including an information sheet, resource, questionnaire and reply paid envelope for returning the questionnaire will be mailed to potential participants.

Eligibility
Key inclusion criteria
Update
Group 1: Adult related stem cell transplant donors of planned allogeneic transplant recipients.
Group 2: Adult related lymphocyte donors of planned lymphocyte infusion recipients.
Group 3: BMT Nurses within the RBWH and Westmead Hospital Haematology and Bone Marrow Transplant Units.

1) Ages eligible for study: 18 to 70 years
2) Able to provide informed consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People whose primary language is other than English
Women who are pregnant and the human fetus
Children and/or young people (ie. <18 years)
People with a cognitive impairment, an intellectual disability or a mental illness

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analysis of historical related stem cell donors at RBWH demonstrates that an estimated 25 related donors are recruited per year. Enrolment is expected to be completed within 23 months, providing a potential sample size of 47 donors. Up to 10 related donors will be recruited from the Westmead Hospital. Based on previous prospective studies of related donors that utilised 3 or more time-points, we expect a participation rate of 50%. Therefore, we expect that 57 related SCT donors will be eligible to participate and assume that 28 related SCT donors will agree to participate.

A total of 7 BMT Nurses will be recruited from the two sites. Up to 6 related lymphocyte infusion donors will be recruited from the two sites to pilot the effect of GCSF on saliva.

Therefore, the target sample size is comprised of 28 related stem cell donors, 6 related lymphocyte donors, and 7 BMT Nurses, providing a total of 41 study participants.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
16/02/2017
Date of last participant enrolment
Anticipated
1/09/2018
Actual
20/04/2018
Date of last data collection
Anticipated
1/11/2018
Actual
Sample size
Target
41
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 7554 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 7555 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 15447 0
2145 - Westmead
Recruitment postcode(s) [2] 15446 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 295722 0
Government body
Name [1] 295722 0
Australian Government Department of Education and Training
Country [1] 295722 0
Australia
Funding source category [2] 295723 0
Hospital
Name [2] 295723 0
Royal Brisbane & Women's Hospital Foundation
Country [2] 295723 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
University of Queensland, School of Medicine
Level 6, UQ Oral Health Centre (Bldg. 883)
288 Herston Road
Herston, QLD 4006
Country
Australia
Secondary sponsor category [1] 294742 0
None
Name [1] 294742 0
Address [1] 294742 0
Country [1] 294742 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297025 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 297025 0
Level 7 Block 7
Butterfield St
Herston QLD 4029
Ethics committee country [1] 297025 0
Australia
Date submitted for ethics approval [1] 297025 0
26/05/2016
Approval date [1] 297025 0
01/08/2016
Ethics approval number [1] 297025 0
HREC/16/QRBW/207
Ethics committee name [2] 297026 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 297026 0
The University of Queensland
Cumbrae-Stewart, Building 72
QLD 4072
Ethics committee country [2] 297026 0
Australia
Date submitted for ethics approval [2] 297026 0
21/09/2016
Approval date [2] 297026 0
12/10/2016
Ethics approval number [2] 297026 0
2016001438

Summary
Brief summary
Background: While World Marrow Donor Association Standards ensure consistency in the assessment and care of unrelated haematopoietic stem cell (HSC) donors, no such criteria exist for related HSC donors. Unlike unrelated donors, related donors are actively involved in the transplant process and witness first-hand the changes in their relative’s health. Their lived experience is thus likely to be very different from that of unrelated donors and it is important to understand and address their needs.

Aim: The aim of this PhD project is to identify potential predictors of psychosocial distress and unmet needs of adult related HSC donors, to develop information resources for health
professionals and develop and pilot test a psycho-educational resource for donors.

PHASE I
Participants are adults undergoing HSC donation for a related recipient at the RBWH and Westmead Hospital, Sydney. Donors complete 3 interviews and provide 3 samples of saliva (as a measure of stress): (1) 2 weeks pre-HSC collection; (2) within 24hrs of HSC collection and; (3) 30 days post-HSC collection. An interview with BMT Nurses will explore the nature of their role, their perceptions of the psychosocial needs of donors and their role (if any) in responding to donor distress.

Hypotheses: As research into adult related donors is limited, findings from research with younger related HSC donors and adult bone marrow donors were used to make the following predictions:
1. Donor perceptions of the closeness of the relationship with the recipient will be associated with post-donation reactions such as guilt, responsibility and stress.
2. Perceived adequacy of preparation and emotional support will correlate with post-donation reactions such as concern for own health, physical pain/discomfort, guilt and responsibility.
3. Donors with poorer self-evaluated health-related quality of life will report more negative
reactions throughout the process.
4. Donors of recipients who experience adverse clinical events (such as development of graft versus-host-disease) will experience increased distress and anxiety.
5. Donor reactions such as stress/physical pain will correlate with high salivary a-amylase
levels throughout the process.

PHASE II
Key indicators that identify risk of HSC donation-related distress will be used to develop a paper-based psycho-educational resource that seeks to reduce related HSC donor distress and may be appropriate for integration within the health system. We aim to assess acceptability, feasibility and potential efficacy and inform the development of a large post-doctoral study which will be required to validate the tool.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1523 1523 0 0
/AnzctrAttachments/371999-UQ HREC Approval Letter 12Oct2016.pdf (Ethics approval)

Contacts
Principal investigator
Name 71054 0
Ms Nienke Zomerdijk
Address 71054 0
Cancer Care Services
Building 34, Ground Floor, Clinical Research Unit
Royal Brisbane & Women’s Hospital
Herston, Qld 4029
Country 71054 0
Australia
Phone 71054 0
+617 3646 6652
Fax 71054 0
+617 3646 7371
Email 71054 0
Nienke.Zomerdijk@health.qld.gov.au
Contact person for public queries
Name 71055 0
Nienke Zomerdijk
Address 71055 0
Cancer Care Services
Building 34, Ground Floor, Clinical Research Unit
Royal Brisbane & Women’s Hospital
Herston, Qld 4029
Country 71055 0
Australia
Phone 71055 0
+617 3646 6652
Fax 71055 0
+617 3646 7371
Email 71055 0
Nienke.Zomerdijk@health.qld.gov.au
Contact person for scientific queries
Name 71056 0
Nienke Zomerdijk
Address 71056 0
Cancer Care Services
Building 34, Ground Floor, Clinical Research Unit
Royal Brisbane & Women’s Hospital
Herston, Qld 4029
Country 71056 0
Australia
Phone 71056 0
+617 3646 6652
Fax 71056 0
+617 3646 7371
Email 71056 0
Nienke.Zomerdijk@health.qld.gov.au

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