Psychological Intervention for Distress During HSCT
Development and Evaluation of a Psychological Intervention to Alleviate Distress During Haematopoietic Stem-cell Transplantation
1 other identifier
interventional
45
1 country
2
Brief Summary
This Phase II trial aims to evaluate a new psychological intervention to alleviate distress during haematopoietic stem cell transplantation (HSCT) together with examining feasibility. HSCT is a complex procedure aimed at a range of haematological and autoimmune illnesses. Over 3,000 individuals undergo the procedure every year in the UK with substantial benefits. However, it is very costly, intensive, and has a range of debilitating side effects. Consequently, patients often experience considerable distress, which can impede recovery. A 90-minute, group-based intervention has been developed to address this need based on psychological theory of adjustment to illness-related difficulties. It is delivered by the transplant team and involves provision of information to foster more helpful perceptions about HSCT and facilitating more helpful coping with its difficulties. To evaluate the effectiveness of the intervention in alleviating distress, 60 patients about to undergo HSCT at two sites (Sheffield \& Nottingham) will be randomly allocated into two groups. Patients in the intervention group will receive the new intervention prior to transplantation together with treatment as usual (TAU) while patients in the control group will receive TAU alone. Participants and the researcher collecting the data will be blind to the allocation. Demographic and relevant clinical information will be recorded at the end of participation to ensure effectiveness of randomisation. For both groups, resilience, distress, coping, and procedure-related perceptions will be measured at four time points: (i) prior to the intervention/transplantation, (ii) day of transplant, (iii) two weeks following the transplant, and (iv) four weeks following the transplant. It is hypothesised that patients in the intervention group will experience higher resilience and lower distress compared to controls and that this difference will be mediated by procedure-related perceptions and coping. A subgroup of participants of those randomised to the group intervention will be invited to participate in a feedback interview at the end.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2014
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2014
CompletedFirst Posted
Study publicly available on registry
August 8, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 28, 2015
October 1, 2015
1.1 years
August 4, 2014
October 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Baseline
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Day 0 (transplant day)
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Day 14
Depression Anxiety Stress Scales (DASS-21)
Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
Day 28
Secondary Outcomes (12)
Brief Resilience Scale (BRS)
Baseline
Brief Resilience Scale (BRS)
Day 0 (transplant day)
Brief Resilience Scale (BRS)
Day 14
Brief Resilience Scale (BRS)
Day 28
Brief Coping with Problems Experienced scale (COPE)
Baseline
- +7 more secondary outcomes
Study Arms (2)
Psychological preparation + TAU
EXPERIMENTALTAU=treatment as usual
Treatment as usual
NO INTERVENTIONUsual care including medication, nursing, and psychologist support.
Interventions
Ninety-minute, group-based psychological preparation delivered prior to haematopoietic stem cell transplantation aiming at alleviating psychological distress during the procedure by enhancing perceptions of the procedure and fostering more helpful coping.
Eligibility Criteria
You may qualify if:
- patients referred for HSCT as treatment for haematological malignancy
- age of 18 years or older
- sufficient command of the English language or access to suitable support to comprehend materials and participate in the group and data collection over the telephone
- informed consent
- permission will also be sought by the patient's Consultant Haematologist once clients have consented
You may not qualify if:
- Consent withdrawn
- Consultant Haematologist raises concern regarding participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nottingham City Hospital
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Schröder, PhD
University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2014
First Posted
August 8, 2014
Study Start
September 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 28, 2015
Record last verified: 2015-10