Bone Marrow Transplantation, Haematopoietic Stem Cell Transplantation, Psychological Distress
Conditions
Keywords
Distress, Depression, Anxiety, Stress, Coping, Illness perceptions, Stem cell transplantation, Bone marrow transplantation
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.
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.
Sponsors
Nottingham University Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Anxiety Stress Scales (DASS-21) | Baseline | Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Resilience Scale (BRS) | Baseline | Assesses resilience; 6 items, Likert-type. |
| Brief Coping with Problems Experienced scale (COPE) | Baseline | Assesses coping styles; 28-item, Likert-type. |
| Brief Illness Perceptions Questionnaire (IPQ) | Baseline | Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type. |
Countries
United Kingdom
Outcome results
None listed