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Psychological Intervention for Distress During HSCT

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ClinicalTrials.gov Identifier: NCT02212236
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : October 28, 2015
Sponsor:
Collaborators:
Nottingham University Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Psychological Distress Haematopoietic Stem Cell Transplantation Bone Marrow Transplantation Other: Psychological preparation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Development and Evaluation of a Psychological Intervention to Alleviate Distress During Haematopoietic Stem-cell Transplantation
Study Start Date : September 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: Psychological preparation + TAU
TAU=treatment as usual
Other: Psychological preparation
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.

No Intervention: Treatment as usual
Usual care including medication, nursing, and psychologist support.



Primary Outcome Measures :
  1. Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Baseline ]
    Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.

  2. Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Day 0 (transplant day) ]
    Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.

  3. Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Day 14 ]
    Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.

  4. Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Day 28 ]
    Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.


Secondary Outcome Measures :
  1. Brief Resilience Scale (BRS) [ Time Frame: Baseline ]
    Assesses resilience; 6 items, Likert-type.

  2. Brief Resilience Scale (BRS) [ Time Frame: Day 0 (transplant day) ]
    Assesses resilience; 6 items, Likert-type.

  3. Brief Resilience Scale (BRS) [ Time Frame: Day 14 ]
    Assesses resilience; 6 items, Likert-type.

  4. Brief Resilience Scale (BRS) [ Time Frame: Day 28 ]
    Assesses resilience; 6 items, Likert-type.

  5. Brief Coping with Problems Experienced scale (COPE) [ Time Frame: Baseline ]
    Assesses coping styles; 28-item, Likert-type.

  6. Brief Coping with Problems Experienced scale (COPE) [ Time Frame: Day 0 (transplant day) ]
    Assesses coping styles; 28-item, Likert-type.

  7. Brief Coping with Problems Experienced scale (COPE) [ Time Frame: Day 14 ]
    Assesses coping styles; 28-item, Likert-type.

  8. Brief Coping with Problems Experienced scale (COPE) [ Time Frame: Day 28 ]
    Assesses coping styles; 28-item, Likert-type.

  9. Brief Illness Perceptions Questionnaire (IPQ) [ Time Frame: Baseline ]
    Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.

  10. Brief Illness Perceptions Questionnaire (IPQ) [ Time Frame: Day 0 (transplant day) ]
    Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.

  11. Brief Illness Perceptions Questionnaire (IPQ) [ Time Frame: Day 14 ]
    Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.

  12. Brief Illness Perceptions Questionnaire (IPQ) [ Time Frame: Day 28 ]
    Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212236


Locations
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United Kingdom
Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Sponsors and Collaborators
University of Nottingham
Nottingham University Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Thomas Schröder, PhD University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02212236     History of Changes
Other Study ID Numbers: 14069
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Keywords provided by University of Nottingham:
Distress
Depression
Anxiety
Stress
Coping
Illness perceptions
Stem cell transplantation
Bone marrow transplantation