Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000071325
Ethics application status
Approved
Date submitted
10/11/2016
Date registered
13/01/2017
Date last updated
7/05/2019
Date data sharing statement initially provided
7/05/2019
Date results information initially provided
7/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment information needs of individuals diagnosed with early stage non-small cell lung cancer and their support people
Scientific title
Treatment information needs of individuals diagnosed with early stage non-small cell lung cancer and their support people
Secondary ID [1] 290472 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 300841 0
Condition category
Condition code
Cancer 300666 300666 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participation involves a 30-60 minute semi-structured interview face-to-face or over the phone. interviews cover:
- sources of treatment information
- whether the information they were exposed to was easy to understand
- what in particular did they want to know about treatment
- the level of satisfaction with the information available
Intervention code [1] 296326 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300090 0
Understanding what patients want to know about treatment,
Timepoint [1] 300090 0
At time of interview
Primary outcome [2] 300732 0
How health literacy impacts participants ability to understand information.
Timepoint [2] 300732 0
At time of interview
Secondary outcome [1] 328996 0
None
Timepoint [1] 328996 0
None

Eligibility
Key inclusion criteria
Individuals who have completed treatment (surgery or radiotherapy) for early stage non-small cell lung cancer between three and twenty months ago; support people who attended appointments with an Individual who have completed treatment for early stage non-small cell lung cancer between three and twenty months ago
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged under 18 or over 80
Non-English speaking

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Qualitative; thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/03/2015
Date of last participant enrolment
Anticipated
30/12/2017
Actual
6/04/2018
Date of last data collection
Anticipated
30/12/2017
Actual
6/04/2018
Sample size
Target
60
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6886 0
The Alfred - Prahran
Recruitment hospital [2] 6887 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 9069 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 9070 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 17562 0
2170 - Liverpool
Recruitment postcode(s) [2] 17563 0
2560 - Campbelltown
Recruitment postcode(s) [3] 14554 0
3004 - Prahran
Recruitment postcode(s) [4] 14555 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 294887 0
University
Name [1] 294887 0
Deakin University
Country [1] 294887 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
220 Burwood Highway, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 293724 0
None
Name [1] 293724 0
Address [1] 293724 0
Country [1] 293724 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296265 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 296265 0
Ground Floor
Linay Pavilion
The Alfred
55 Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 296265 0
Australia
Date submitted for ethics approval [1] 296265 0
03/09/2014
Approval date [1] 296265 0
12/12/2014
Ethics approval number [1] 296265 0
391/14
Ethics committee name [2] 296266 0
Monash Health Human Research Ethics Committee
Ethics committee address [2] 296266 0
Research Support Services
Level 2, i Block
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [2] 296266 0
Australia
Date submitted for ethics approval [2] 296266 0
02/03/2016
Approval date [2] 296266 0
17/06/2016
Ethics approval number [2] 296266 0
16119X
Ethics committee name [3] 296302 0
Deakin University Human Research Ethics Committee
Ethics committee address [3] 296302 0
Deakin University
221 Burwood Highway, Burwood
Victoria 3125
Ethics committee country [3] 296302 0
Australia
Date submitted for ethics approval [3] 296302 0
09/03/2015
Approval date [3] 296302 0
25/05/2015
Ethics approval number [3] 296302 0
2015-099
Ethics committee name [4] 298651 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [4] 298651 0
‘Research and Ethics Office’
Locked Bag 7103
LIVERPOOL BC NSW 1871
Ethics committee country [4] 298651 0
Australia
Date submitted for ethics approval [4] 298651 0
07/08/2017
Approval date [4] 298651 0
17/08/2017
Ethics approval number [4] 298651 0
SSA/17/LPOOL/325

Summary
Brief summary
The primary purpose of this study is to evaluate the treatment information needs for people with non-small cell lung cancer (NSCLC).

Who is it for?
You may be eligible to participate in this study if you are aged 18 to 80 years, and have been diagnosed with, or are the support person for somebody who has been diagnosed with NSCLC for which surgical or radiotherapy treatment finished between three and twenty months previously.

Study details
All participants enrolled in this study will participate in an 30-60 minute interview (either face-to-face or over the telephone).

It is hoped that the findings from this study will provide information on the views of NSCLC patients and their support people on participation in treatment decision making, understanding treatment options and confidence in communication with clinicians.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes
Not applicable

Contacts
Principal investigator
Name 70194 0
Dr Sashendra Senthi
Address 70194 0
William Buckland Radiotherapy Centre
The Alfred
55 Commercial Road
Pharan VIC 3004
Country 70194 0
Australia
Phone 70194 0
+61 390768995
Fax 70194 0
Email 70194 0
s.senthi@alfred.org.au
Contact person for public queries
Name 70195 0
Ms Melissa Maas
Address 70195 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway, Burwood
Victoria 3125
Country 70195 0
Australia
Phone 70195 0
+61438767619
Fax 70195 0
Email 70195 0
mmaas@deakin.edu.au
Contact person for scientific queries
Name 70196 0
Dr Sashendra Senthi
Address 70196 0
William Buckland Radiotherapy Centre
The Alfred
55 Commercial Road
Pharan VIC 3004
Country 70196 0
Australia
Phone 70196 0
+61 390768995
Fax 70196 0
Email 70196 0
s.senthi@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is a qualitative study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo To address the aims related to patient needs, a pu... [More Details]

Documents added automatically
No additional documents have been identified.