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Trial registered on ANZCTR


Registration number
ACTRN12614000229673
Ethics application status
Not yet submitted
Date submitted
13/02/2014
Date registered
4/03/2014
Date last updated
4/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the feasibility and utility of a Quality of Life instrument as a clinical aid in cancer and palliative care
Scientific title
In patients with advanced cancer, is the QUAL-E instrument feasible and clinically useful in inpatient or outpatient hospital care?
Secondary ID [1] 284047 0
Nil
Universal Trial Number (UTN)
U1111-1153-1298
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced cancer 291104 0
Condition category
Condition code
Cancer 291447 291447 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Quality of Life at the End of Life (QUAL-E) instrument is a survey to measure quality of life at end of life from the patient's perspective. Originally a 25-item self-report tool, the instrument investigates 4 domains: a) life completion; b) relationship with health providers, c) preparation for end of life; and d) symptom impact. The QUAL-E was validated in 2011 as a reduced 17-item version. Piloting the tool with Australian hospital palliative care patients in 2009 revealed its potential utility as aid from clinical care when administered as an interview by research assistant.
This current trial will further pilot the QUAL-E to evaluate its feasibility and clinical utility when administered as an interview. The QUAL-E interviews will be conducted by a research assistant with nursing and research experience. Each interview will be conducted face-to-face and audio-recorded. The research assistant will document patient participants' responses to each item on a hard copy instrument. Audio-recording of the QUAL-E interview will also be audio-recorded to faciltate the capture, transcription and content analysis of patients' qualitative responses. Each patient will be interviewed once; there will be no follow-up. It is envisaged that each interview will last approximately 30 minutes.
Intervention code [1] 288740 0
Other interventions
Comparator / control treatment
This study aims to explore the utility of the QUAL-E as an aid for clinical care and whether it is feasible to use in inpatient and outpatient settings. This is a single group study where the intervention will be applied to all participants.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291429 0
Patient qualitative responses indicating need for psychosocial support to the 17-item QUAL-E administered as interview
Timepoint [1] 291429 0
Baseline
Secondary outcome [1] 306749 0
Association between QUAL-E domain subscores and Distress Thermometer scores
Timepoint [1] 306749 0
Baseline
Secondary outcome [2] 306750 0
Patient feasibility survey responses
Timepoint [2] 306750 0
Baseline

Eligibility
Key inclusion criteria
Diagnosis of advanced cancer
Receiving inpatient palliative care or outpatient cancer care
Physically and emotionally able to participate
Able to speak and read English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Outpatients not attending study clinic
Inpatients not receiving care from the hospital Palliative Care Service

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Convenience sampling will be used to select potential participants who are outpatients or inpatients who fit the inclusion criteria during data collection periods.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Recruitment will continue until saturation of the qualitative data is reached in each of the inpatient and outpatient groups. It is envisaged that the total sample size willl be 50.
1. Demographic characteristics will be summarised using descriptive statistics to provide a profile of the sample.
2. Qualitative analysis:
Audio recorded interviews will be transcribed verbatim and transcripts subjected to thematic analysis. Coding of the data will be managed using N-vivo software.
3.Quantitative analysis
The duration in minutes taken to complete the QUAL-E instruments and participants’ responses to the five feasibility questions analysed to produce descriptive statistics, including means, range, and frequencies.
Patient’s QUAL-E domain scores will be compared to Distress Thermomter scale ratings to determine potential relationships for future examination. Summary statistics including means and standard deviations for symmetric data, and medians and quartiles for asymmetric data will be provided for all quantitative variables (i.e. the 4 domains of life completion, relationship with healthcare provider, preparation for end of life and symptom impact from the QUAL-E instrument as well as DT scores). Frequency tables will be provided for the dichotomous variables listed in the problem list on the DT survey. Relationships between patients’ QUAL-E domain scores and DT scores will be investigated using correlation and regression analyses and graphical displays. All analyses will be conducted using the R environment for statistical computing (R 2013).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/03/2014
Actual
Date of last participant enrolment
Anticipated
30/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2086 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 7773 0
6009 - Broadway Nedlands

Funding & Sponsors
Funding source category [1] 288719 0
University
Name [1] 288719 0
Cancer and Palliative Care Research Evaluation Unit
The University of Western Australia
Country [1] 288719 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 287421 0
None
Name [1] 287421 0
Address [1] 287421 0
Country [1] 287421 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290558 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 290558 0
Level 2 A block
Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 290558 0
Australia
Date submitted for ethics approval [1] 290558 0
26/11/2013
Approval date [1] 290558 0
Ethics approval number [1] 290558 0
2013-218

Summary
Brief summary
The study is evaluating the feasibility and utility of the Quality of Life at the End of Life (QUAL-E) instrument in helping staff care for and understand the concerns of people with advanced cancer. Who is it for? You may be eligible to join this study if you are aged over 18 years, have a diagnosis of advanced cancer and receiving inpatient palliative care or outpatient cancer care at the study hospital. Trial details All participants in this study will complete an interview with the QUAL-E used as an interview tool. The QUAL-E instrument explores four domains: symptom impact, relationship with healthcare providers, life completion and preparation for end of life, which have been found to influence patients’ quality of life. This study will use mixed methods to conduct a qualitative content analysis of patients’ responses to the QUAL-E when administered by a research nurse, and a quantitative assessment of feasibility and the possible association between QUAL-E and Distress Thermometer scores.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46094 0
Dr Susan Slatyer
Address 46094 0
Centre for Nursing Research
Sir Charles Gairdner Hospital
Room 127, Harry Perkins Institute for Medical Research
Hospital Avenue
Nedlands WA 6009
Country 46094 0
Australia
Phone 46094 0
+61 8 61510799
Fax 46094 0
Email 46094 0
[email protected]
Contact person for public queries
Name 46095 0
Dr Susan Slatyer
Address 46095 0
Centre for Nursing Research
Sir Charles Gairdner Hospital
Room 127, Harry Perkins Institute for Medical Research
Hospital Avenue
Nedlands WA 6009
Country 46095 0
Australia
Phone 46095 0
+61 8 61510799
Fax 46095 0
Email 46095 0
[email protected]
Contact person for scientific queries
Name 46096 0
Dr Susan Slatyer
Address 46096 0
Centre for Nursing Research
Sir Charles Gairdner Hospital
Room 127, Harry Perkins Institute for Medical Research
Hospital Avenue
Nedlands WA 6009
Country 46096 0
Australia
Phone 46096 0
+61 8 61510799
Fax 46096 0
Email 46096 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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