NCT02349776

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

January 26, 2015

Last Update Submit

August 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Structured interviews

    The short structured interviews investigating patient's experience of the intervention at two time-points following the intervention

    3 months

Study Arms (1)

All patients for allograft transplant

EXPERIMENTAL

For the testimonial part all patients who have received an allograft transplant in the last five years will be eligible for participation if they have capacity to consent and can speak English fluently.

Other: Providing testimonies from survivors of transplants to patients

Interventions

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.

All patients for allograft transplant

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

January 29, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations