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

Psychological Intervention for Distress During HSCT

Sponsors

Lead sponsor: University of Nottingham

Collaborator: Nottingham University Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust

Source 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.

Overall Status Completed
Start Date September 2014
Completion Date October 2015
Primary Completion Date October 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Depression Anxiety Stress Scales (DASS-21) Baseline
Depression Anxiety Stress Scales (DASS-21) Day 0 (transplant day)
Depression Anxiety Stress Scales (DASS-21) Day 14
Depression Anxiety Stress Scales (DASS-21) Day 28
Secondary Outcome
Measure Time Frame
Brief Resilience Scale (BRS) Baseline
Brief Resilience Scale (BRS) Day 0 (transplant day)
Brief Resilience Scale (BRS) Day 14
Brief Resilience Scale (BRS) Day 28
Brief Coping with Problems Experienced scale (COPE) Baseline
Brief Coping with Problems Experienced scale (COPE) Day 0 (transplant day)
Brief Coping with Problems Experienced scale (COPE) Day 14
Brief Coping with Problems Experienced scale (COPE) Day 28
Brief Illness Perceptions Questionnaire (IPQ) Baseline
Brief Illness Perceptions Questionnaire (IPQ) Day 0 (transplant day)
Brief Illness Perceptions Questionnaire (IPQ) Day 14
Brief Illness Perceptions Questionnaire (IPQ) Day 28
Enrollment 45
Condition
Intervention

Intervention type: Other

Intervention name: Psychological preparation

Description: 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.

Arm group label: Psychological preparation + TAU

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Thomas Schröder, PhD Principal Investigator University of Nottingham
Location
facility
Nottingham City Hospital | Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Royal Hallamshire Hospital | Sheffield, South Yorkshire, S10 2JF, United Kingdom
Location Countries

United Kingdom

Verification Date

October 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Psychological preparation + TAU

Arm group type: Experimental

Description: TAU=treatment as usual

Arm group label: Treatment as usual

Arm group type: No Intervention

Description: Usual care including medication, nursing, and psychologist support.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov