Psychological Intervention for Distress During HSCT
- Conditions
- Bone Marrow TransplantationPsychological DistressHaematopoietic Stem Cell Transplantation
- Interventions
- Other: Psychological preparation
- Registration Number
- NCT02212236
- Lead Sponsor
- University of Nottingham
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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
- Consent withdrawn
- Consultant Haematologist raises concern regarding participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psychological preparation + TAU Psychological preparation TAU=treatment as usual
- Primary Outcome Measures
Name Time Method Depression Anxiety Stress Scales (DASS-21) Day 28 Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
- Secondary Outcome Measures
Name Time Method Brief Resilience Scale (BRS) Day 28 Assesses resilience; 6 items, Likert-type.
Brief Coping with Problems Experienced scale (COPE) Day 28 Assesses coping styles; 28-item, Likert-type.
Brief Illness Perceptions Questionnaire (IPQ) Day 28 Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
Trial Locations
- Locations (2)
Nottingham City Hospital
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, South Yorkshire, United Kingdom