Psychological Intervention for Distress During HSCT

Study Overview
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Brief Summary
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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.

Official Title
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Development and Evaluation of a Psychological Intervention to Alleviate Distress During Haematopoietic Stem-cell Transplantation

Conditions
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Psychological Distress, Haematopoietic Stem Cell Transplantation, Bone Marrow Transplantation

Intervention / Treatment
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* Other: Psychological preparation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological preparation + TAU<br>TAU=treatment as usual | Other: Psychological preparation<br>* 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.<br>|
| No Intervention: Treatment as usual<br>Usual care including medication, nursing, and psychologist support. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Resilience Scale (BRS) | Assesses resilience; 6 items, Likert-type. | Baseline | 
| Brief Resilience Scale (BRS) | Assesses resilience; 6 items, Likert-type. | Day 0 (transplant day) | 
| Brief Resilience Scale (BRS) | Assesses resilience; 6 items, Likert-type. | Day 14 | 
| Brief Resilience Scale (BRS) | Assesses resilience; 6 items, Likert-type. | Day 28 | 
| Brief Coping with Problems Experienced scale (COPE) | Assesses coping styles; 28-item, Likert-type. | Baseline | 
| Brief Coping with Problems Experienced scale (COPE) | Assesses coping styles; 28-item, Likert-type. | Day 0 (transplant day) | 
| Brief Coping with Problems Experienced scale (COPE) | Assesses coping styles; 28-item, Likert-type. | Day 14 | 
| Brief Coping with Problems Experienced scale (COPE) | Assesses coping styles; 28-item, Likert-type. | Day 28 | 
| Brief Illness Perceptions Questionnaire (IPQ) | Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type. | Baseline | 
| Brief Illness Perceptions Questionnaire (IPQ) | Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type. | Day 0 (transplant day) | 
| Brief Illness Perceptions Questionnaire (IPQ) | Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type. | Day 14 | 
| Brief Illness Perceptions Questionnaire (IPQ) | Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type. | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distress, Depression, Anxiety, Stress, Coping, Illness perceptions, Stem cell transplantation, Bone marrow transplantation