Condition category
Cancer
Date applied
09/12/2009
Date assigned
18/05/2010
Last edited
16/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Tom Møller (Moeller)

ORCID ID

Contact details

The University Hospitals Centre for Nursing and Care Research UCSF
Rigshospitalet afsnit 7331
Blegdamsvej 9
Copenhagen
2100
Denmark
+45 (0)3545 7336
ucsf@ucsf.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Patient education as a complementary non-pharmacological intervention towards hospital acquired lung infection among patients with acute myeloid leukaemia and chemotherapy induced neutropenia

Acronym

Study hypothesis

Individualised structured patient education including clinical procedures for self-measurement of Lung Capacity / Spirometry in combination with Positive Expiratory pressure (PEP) can reduce hospital acquired pneumonia.

Ethics approval

1. The Ethical Scientific Committee of Copenhagen Region, 19/06/2008, ref: H-D-2008-025
2. The Danish Data Protection Agency, 22/01/2008, ref: 2008-41-1728

Study design

Randomised controlled clinical intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute Myeloid Leukaemia (AML); lung infection prevention

Intervention

Patient education and training to perform self-measurement of lung capacity and mechanical lung traning with Positive Expiratory Pressure (PEP).

Patients are included when diagnosed with AML and chemotherapy has commenced. Follow-up period is planned to 3 months after inclusion.

The intervention is nurse-led and consists of a structured three level based patient education program given individually to each patient. One program given to both control and intervention group is used for patients’ training in self-measurement of lung capacity / spirometry twice a day with an electronic pocket monitor, 'PiKo-6'. The time spent by the clinical nurse specialist for initial instruction and education in spirometry varies within 1.5 - 2.5 hours per patient.

The second program is provided only to the intervention group and deals with lung training consisting Positive Expiratory Pressure (PEP) using a PEP-flute twice to four times daily depending on values from lung capacity measurement. Time used for initial instruction varies from 30 mins to 1 hour per patient.

Both programs describe focus, actions and aims on each of the three levels in the forms. Patients are left in charge when completing the 3 levels based on appraisal from the clinical nurse specialist. Patients are seen as inpatients or outpatients every 7 - 14 days to discuss patients’ assessments and visualize their lung capacity on an EDB-based monitor.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Incidence of X-ray verified lung infiltrates during the 3 month follow up period
2. Forced Expiratory Volume in 1 second (FEV1) as predictive diagnostic tool for pneumonia

Secondary outcome measures

1. Quality of Life (QOL) - EORTC-QLQ-C30
2. SF36 short form
3. Hospital Anxiety Depression (HAD)
4. Self-efficacy
5. Coping - Mini Mental Adjustment to Cancer (Mini-MAC)
Above outcomes measured at baseline and at 3 month follow up
6. Qualitative findings derived from semi-structured interviews conducted at the end of 3 month follow up.

Overall trial start date

01/10/2008

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (>18 years) with Acute Myeloid Leukaemia (AML) and Myelodysplatic Syndrome demanding intensive intravenous chemotherapy and diagnosed at the Copenhagen University Hospitales Rigshospitalet and Herlev Hospital.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. non-Danish speaking
2. Psychotic patients
3. Patients requiring care in Intensive Care Units (ICUs)

Recruitment start date

01/10/2008

Recruitment end date

01/12/2010

Locations

Countries of recruitment

Denmark

Trial participating centre

The University Hospitals Centre for Nursing and Care Research UCSF
Copenhagen
2100
Denmark

Sponsor information

Organisation

Lundbeck Foundation (Denmark)

Sponsor details

Universitetshospitalernes Center for Sygepleje- og Omsorgsforskning
Rigshospitalet afsnit 7331
Blegdamsvej 9
2100 København Ø
Copenhagen
2100
Denmark
+45 (0)35457336
bente@ucsf.dk

Sponsor type

Charity

Website

http://www.ucsf.dk/

Funders

Funder type

Charity

Funder name

Lundbeck Foundation (Denmark) (ref: FP 28/2007)

Alternative name(s)

Lundbeck Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Denmark

Funder name

Copenhagen University Hospital Rigshospitalet (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Wedell-Wedellsborg Foundation (Denmark) (ref: 381668/933)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

ANCOTRANS (Denmark) - Donation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Familien Hede Nielsens Foundation (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ole Wissing's Foundation for Research in Leukaemia (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26661344

Publication citations

Additional files

Editorial Notes