COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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] 14554 0
3004 - Prahran
Recruitment postcode(s) [2] 14555 0
3168 - Clayton
Recruitment postcode(s) [3] 17562 0
2170 - Liverpool
Recruitment postcode(s) [4] 17563 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 294887 0
University
Name [1] 294887 0
Deakin University
Address [1] 294887 0
220 Burwood Highway, Burwood VIC 3125
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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
To address the aims related to patient needs, a purposive sample of 22 early-stage NSCLC patients and five support people participated in semi-structured interviews. Inductive thematic analysis was utilised to analyse the transcripts of semi-structured interviews undertaken with patients and support people. Five themes were identified in the patient study, including: treatment decision-making; treatment-related information needs; health literacy; professionalism of the doctor; and the function of support people. The majority of participants did not participate in treatment decision-making and were content with the proposed treatment plan presented to them by the treating doctor. However, most patients believed that, in principle, patient involvement in treatment decision-making was appropriate. In general, patients indicated that they were not interested in receiving much information regarding treatment and possible outcomes, with some stating that this was because they wanted to avoid information that they might find distressing. Patients unanimously expressed their preference to receive information from their treating clinician. Many patients verbalised that they found the information presented to them easy to understand, and some recognised that information they found in booklets or on the internet might not apply to their current situation. The majority of patients felt comfortable in seeking a second opinion; however, only one patient had done so. Patients’ perceptions of doctors’ expertise appeared to shape their views regarding the level of involvement preferred in decision-making and the amount of information needed. The patients generally regarded support people as performing a crucial role during pre-treatment consultations, primarily for assistance in questioning, recall of information, and general support.

Results from interviews with support people identified four themes: information needs; understanding and evaluating information; the role of the support person; and decision-making. Identified were preferences in learning the potential outcomes of treatment and life expectancy and understanding what the treatment would entail. Most reported being able to understand the information covered in consultations with the treating doctor and also recognised that information available on the internet might not be relevant. Support people reflected on the part that they played in initial consultations and, similarly to the patients, identified that they asked questions during consultations. Support people also recognised that they presumed the role of advocate for the patient, performing duties such as ensuring that the patient understood the information presented and acting as a buffer between medical and administrative staff to reduce the burden on the patient. Support people described gathering information in an active manner, asking the treating clinician and their general practitioner questions, and searching on the internet. Unlike the patient group, support people identified why they sought information, and in most cases it was to assist in knowing what to expect.