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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02349776
Other study ID # GS12/10259
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date September 1, 2017

Study information

Verified date August 2019
Source The Leeds Teaching Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Allograft transplants are offered to people with haematological cancers sometimes as the best chance of a cure. However, the survival rates for these procedures can be quite poor, as the transplant, in itself, can be lifethreatening.

In addition, these procedures usually involve a period of lengthy hospitalisation accompanied by a host of debilitating conditions which patients must cope with in isolation due to their increased risk of serious infection. Perhaps unsurprisingly, there is considerable evidence that mood plays a role in the way people recover.

I wish to investigate the psychological impact of providing testimonies from survivors of transplants to patients undergoing the procedure.

The plan is initially to collect about 10-15 testimonials from past transplant patients using a videotaped structured interview then to collate these testimonials into a booklet format and DVD.

This booklet and DVD would be used as an intervention where 40 consecutive patients who are going ahead for transplant are invited to receive the testimonial intervention.

Patients will be asked to complete one mood measure (the HADS), the Life Orientation Test (LOT), and a questionnaire about expectations of treatment in clinic once a decision to proceed to transplant has been made. Patients will receive the testimonies upon admittance to the transplant unit and then receive the HADS and a structured interview within the first week of being admitted to the transplant ward (just prior to receiving the transplant) and within the first two weeks following the transplant.

Comparative analyses of the measures between the three time points would be performed and qualitative analysis of the structured interview data.

Around 80 people undergo transplant each year, it is estimated that the project will be completed by September 2016. The intention would be to publish following completion.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 1, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- For the testimonial part all patients attending bone marrow transplant follow-up clinic who have had an allogenic transplant and who have capacity to consent to the study and who are fluent in English will be eligible.

For the intervention part all patients going forward for allogenic transplant at St James's Institute for Oncology who have capacity to consent to the study and who are fluent in English will be eligible.

Exclusion Criteria:

- Patients without capacity to consent will not be eligible for participation Patients who are not fluent in English will not be eligible for participation Patients who are not going forward for allogenic transplant will not be eligible

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Providing testimonies from survivors of transplants to patients
Patients will be asked to complete one mood measure (the HADS), the Life Orientation Test (LOT), and a questionnaire about expectations of treatment in clinic once a decision to proceed to transplant has been made. Patients will receive the testimonies upon admittance to the transplant unit and then receive the HADS and a structured interview within the first week of being admitted to the transplant ward (just prior to receiving the transplant) and within the first two weeks following the transplant.

Locations

Country Name City State
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds West Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Structured interviews The short structured interviews investigating patient's experience of the intervention at two time-points following the intervention 3 months
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