Clinical trial NCT02212236: Psychological Intervention for Distress During HSCT
Official title: Development and Evaluation of a Psychological Intervention to Alleviate Distress During Haematopoietic Stem-cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psychological Distress
Haematopoietic Stem Cell Transplantation
Bone Marrow Transplantation
Keywords: Distress
Depression
Anxiety
Stress
Coping
Illness perceptions
Stem cell transplantation
Bone marrow transplantation
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2014-08-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Consent withdrawn
* Consultant Haematologist raises concern regarding participation

Primary outcomes:
measure: Depression Anxiety Stress Scales (DASS-21)
timeFrame: Baseline
measure: Depression Anxiety Stress Scales (DASS-21)
timeFrame: Day 0 (transplant day)
measure: Depression Anxiety Stress Scales (DASS-21)
timeFrame: Day 14
measure: Depression Anxiety Stress Scales (DASS-21)
timeFrame: Day 28
Secondary outcomes:
measure: Brief Resilience Scale (BRS)
timeFrame: Baseline
measure: Brief Resilience Scale (BRS)
timeFrame: Day 0 (transplant day)
measure: Brief Resilience Scale (BRS)
timeFrame: Day 14
measure: Brief Resilience Scale (BRS)
timeFrame: Day 28
measure: Brief Coping with Problems Experienced scale (COPE)
timeFrame: Baseline
measure: Brief Coping with Problems Experienced scale (COPE)
timeFrame: Day 0 (transplant day)
measure: Brief Coping with Problems Experienced scale (COPE)
timeFrame: Day 14
measure: Brief Coping with Problems Experienced scale (COPE)
timeFrame: Day 28
measure: Brief Illness Perceptions Questionnaire (IPQ)
timeFrame: Baseline
measure: Brief Illness Perceptions Questionnaire (IPQ)
timeFrame: Day 0 (transplant day)
measure: Brief Illness Perceptions Questionnaire (IPQ)
timeFrame: Day 14
measure: Brief Illness Perceptions Questionnaire (IPQ)
timeFrame: Day 28
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
state: Nottinghamshire
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
affiliation: University of Nottingham
name: Thomas Schröder, PhD
role: PRINCIPAL_INVESTIGATOR
References: