Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02212236
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2014-08-04
Brief Title:
Psychological Intervention for Distress During HSCT
Sponsor:
University of Nottingham
Organization:
University of Nottingham
Study Overview
Official Title:
Development and Evaluation of a Psychological Intervention to Alleviate Distress During Haematopoietic Stem-cell Transplantation
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3000 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 interventiontransplantation 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
HSCT is a complex procedure aimed at a range of haematological and autoimmune illnesses Over 3000 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 interventiontransplantation 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None