Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001165774
Ethics application status
Approved
Date submitted
21/08/2022
Date registered
24/08/2022
Date last updated
22/02/2023
Date data sharing statement initially provided
24/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Survivorship Care For Long-Term Responder Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC): Feasibility of a Multi-Disciplinary Team (MDT) Consultation
Scientific title
Survivorship Care For Long-Term Responder Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC): Feasibility of a Multi-Disciplinary Team (MDT) Consultation
Secondary ID [1] 307650 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metastatic non-small cell lung cancer 327157 0
metastatic cancer survivorship 327158 0
Condition category
Condition code
Cancer 324292 324292 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One-off, virtual, survivorship-focussed multi-disciplinary team (MDT) consultation.

MDT consultation conducted within 4 (ideally) to 6 (maximum) weeks post participant recruitment to study

Intervention: MDT-consultation attended by:
1. Hospital-based team (Minimum: 1 lung cancer specialist clinical nurse, 1 allied health staff, 1 oncology doctor*)
*For the doctor representative, attendance during the first 10 minutes only of the MDT consultation is required.
2. Primary-care clinician
3. Patient participant (+/- 1 family member)

Setting:
• Secure online video-conferencing platform
• One-off structured discussion of 30 minutes per patient discussed, led by lung specialist clinical nurse

Procedure:
• Eligible patients identified via hospital clinics, referred by clinicians or self-referred
• Consented study participants referred to MDT-coordinator who arranges survivorship needs screening prior to MDT-consultation
o 1st standardised participant questionnaire (~20 minutes)
o 2nd Brief phone call (~15 minutes) with one of lung cancer specialist clinical nurse OR lung fellow or registrar following completion of participant questionnaire and pre MDT consultation
• Structured survivorship MDT consultation (encompassing discussion of unmet survivorship needs and concerns as guided by questionnaire) led by lung cancer specialist clinical nurse with output being the formulation of a structured, individualised Survivorship Care Plan (SCP)
• SCP forwarded to patient participant, patient’s own GP, and made available in hospital medical records for hospital-based clinicians
Intervention code [1] 324104 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332107 0
Feasibility: % of patient participants successfully completing the MDT consultation following written consent

Data collected via audit of study records.
Timepoint [1] 332107 0
6 weeks post recruitment of last (30th) participant to study OR 2 years post recruitment of first participant to study whichever is sooner.
Secondary outcome [1] 412218 0
Feasibility: % of patient participant’s own GP attending MDT consultation

Data collected by audit of study records.
Timepoint [1] 412218 0
6 months post recruitment of last participant to study.
Secondary outcome [2] 413250 0
Feasibility: % of patient participants completing post MDT consultation surveys

Surveys custom-designed specifically for the study, standardised amongst patient participants.
Data collected by audit of study records.
Timepoint [2] 413250 0
6 months post recruitment of last participant to study.
Secondary outcome [3] 413251 0
Feasibility: % of GPs completing pre and 3 month post-MDT surveys

Surveys custom-designed specifically for the study, standardised amongst GP participants.
Data collected by audit of study records.
Timepoint [3] 413251 0
6 months post recruitment of last participant to study.
Secondary outcome [4] 413252 0
Acceptability: to participants (3 month post-MDT surveys)

Surveys custom-designed specifically for the study, standardised amongst patient participants.
Data collected by audit of study records.
Timepoint [4] 413252 0
6 months post recruitment of last participant to study.
Secondary outcome [5] 413253 0
Acceptability: to hospital-based teams (qualitative exit interviews)

Purposive sampling of hospital-based health-care providers who have participated in the study. Semi-structured, 1:1 interviews, up to 30 mins duration.
Timepoint [5] 413253 0
To be conducted within (ideally) 3 months and (maximum) 6 months post the final MDT consultation of the study.
Secondary outcome [6] 413254 0
Acceptability: to primary care teams (3-month post-MDT surveys, qualitative exit interviews)

Surveys custom-designed specifically for the study, standardised amongst GP participants.
Data collected by audit of study records.

Convenience sampling of GPs with patients who have participated in the study. Semi-structured, 1:1 interviews, up to 30 mins duration.
Timepoint [6] 413254 0
Interviews will be scheduled within (ideally) 4 and (maximum) 4.5 months following participation in the MDT consultation.

Eligibility
Key inclusion criteria
1. Histologically confirmed unresectable locally advanced or metastatic NSCLC
2. Age >/= 18 years
3. Able to understand, speak and read in English without the use of an interpreter
4. >/= 6 months post initiation of current line of systemic therapy without radiological evidence of disease progression (stable disease, complete or partial response on CT performed within 3 months prior to enrolment; or complete or partial metabolic response, or stable disease on PET)
5. Able to give informed written consent
6. Access to computer with internet connection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Psychiatric comorbidity that would preclude participation in the study procedures
2. A diagnosis of unresectable NSCLC that is being managed with ‘definitive’ or ‘curative’ intent (eg patients with stage III NSCLC undergoing concurrent chemoradiotherapy followed by consolidation durvalumab)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis
This is a pilot study hence descriptive statistics will be utilised to summarise and describe quantitative results obtained during the study.

Thematic analysis will be utilised to underpin analysis of qualitative data obtained during the study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/09/2022
Actual
25/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311911 0
Other
Name [1] 311911 0
Philanthropic funds provided to Chris O'Brien Lifehouse
Country [1] 311911 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119-143 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 313396 0
None
Name [1] 313396 0
Address [1] 313396 0
Country [1] 313396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311347 0
SESLHD HREC
Ethics committee address [1] 311347 0
Ethics committee country [1] 311347 0
Australia
Date submitted for ethics approval [1] 311347 0
Approval date [1] 311347 0
09/05/2022
Ethics approval number [1] 311347 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120798 0
A/Prof Steven Kao
Address 120798 0
C/- Department of Medical Oncology
Chris O'Brien Lifehouse
119-143 Missenden Rd, Camperdown NSW 2050
Country 120798 0
Australia
Phone 120798 0
+61 2 8514 0140
Fax 120798 0
Email 120798 0
[email protected]
Contact person for public queries
Name 120799 0
Sarah Heynemann
Address 120799 0
C/- Department of Medical Oncology
Chris O'Brien Lifehouse
119-143 Missenden Rd, Camperdown NSW 2050
Country 120799 0
Australia
Phone 120799 0
+61 28514 0140
Fax 120799 0
Email 120799 0
[email protected]
Contact person for scientific queries
Name 120800 0
Sarah Heynemann
Address 120800 0
C/- Department of Medical Oncology
Chris O'Brien Lifehouse
119-143 Missenden Rd, Camperdown NSW 2050
Country 120800 0
Australia
Phone 120800 0
+61 2 8514 0140
Fax 120800 0
Email 120800 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be aggregated to the extent required to protect privacy of individual participants.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.