ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

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

metastatic cancer survivorship

Condition category

Condition code

Cancer

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]

Lifestyle

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility: % of patient participants successfully completing the MDT consultation following written consent

Data collected via audit of study records.

Timepoint [1]

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]

Feasibility: % of patient participant’s own GP attending MDT consultation

Data collected by audit of study records.

Timepoint [1]

6 months post recruitment of last participant to study.

Secondary outcome [2]

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]

6 months post recruitment of last participant to study.

Secondary outcome [3]

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]

6 months post recruitment of last participant to study.

Secondary outcome [4]

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]

6 months post recruitment of last participant to study.

Secondary outcome [5]

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]

To be conducted within (ideally) 3 months and (maximum) 6 months post the final MDT consultation of the study.

Secondary outcome [6]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Philanthropic funds provided to Chris O'Brien Lifehouse

Address [1]

C/- Chris O'Brien Lifehouse
119-143 Missenden Rd, Camperdown NSW 2050

Country [1]

Australia

Primary sponsor type

Hospital

Name

Chris O'Brien Lifehouse

Address

119-143 Missenden Rd, Camperdown NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SESLHD HREC

Ethics committee address [1]

SESLHD-RSO 
C/-
Room G7, Level 2, Clinical Science Building
Prince of Wales Hospital, Randwick, NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/05/2022

Ethics approval number [1]

Summary

Brief summary

This study aims to test if it is practical to conduct a one-off multi-disciplinary team (MDT) consultation for patients with advanced non-small cell lung cancer, focussing on survivorship care needs.

Who is it for?
You may be eligible to join this study if you are aged 18 years or older, have advanced non-small cell lung cancer, and have been receiving your current cancer treatment for at least 6 months without the disease getting worse on scans.

Study details
All patients who enrol in this study will be invited to participate in a single, 30-minute, multi-disciplinary team (MDT) meeting via a secure, online video-conferencing platform. The meeting will focus on any unmet needs and concerns the participating patient may have related to survivorship, with discussion led by a lung cancer specialist nurse from the hospital. The MDT will include the patient (+/- a family member), hospital doctor, allied health professional, and a member of the patient’s primary care team (ideally the patient’s GP). Prior to the MDT meeting, all patients will be asked to complete a survey to identify survivorship concerns in order to guide the MDT discussion, and they will receive a 15-minute call by a member of the study team prior to the MDT meeting. The patient’s GP will also be asked to complete a 5-minute questionnaire prior to the MDT. After the MDT meeting a survivorship care plan will be produced summarising the discussion at the MDT meeting, and a copy made available to the patient, the patient’s GP and placed in the patient’s hospital record.

Three months after the MDT meeting, participating patients and GPs will be asked to complete a short follow-up questionnaire about how acceptable the MDT meeting process was. Later on (4-4.5 months post participating in the MDT meeting) some patients and their GPs will also be invited to participate in an interview to discuss their impressions of participating in the MDT meeting.

Rationale
It is hoped that this study will show that a MDT consultation is both feasible and acceptable to patients, hospital and community-based health-care providers, and enable further implementation of these consultations to improve the survivorship care for patients living with advanced non-small cell lung cancer.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Steven Kao

Address

C/- Department of Medical Oncology
Chris O'Brien Lifehouse
119-143 Missenden Rd, Camperdown NSW 2050

Country

Australia

Phone

+61 2 8514 0140

Fax

steven.kao@lh.org.au

Contact person for public queries

Name

Sarah Heynemann

Address

C/- Department of Medical Oncology
Chris O'Brien Lifehouse
119-143 Missenden Rd, Camperdown NSW 2050

Country

Australia

Phone

+61 28514 0140

Fax

shey0696@uni.sydney.edu.au

Contact person for scientific queries

Name

Sarah Heynemann

Address

C/- Department of Medical Oncology
Chris O'Brien Lifehouse
119-143 Missenden Rd, Camperdown NSW 2050

Country

Australia

Phone

+61 2 8514 0140

Fax

shey0696@uni.sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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