ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000594921

Ethics application status

Approved

Date submitted

28/04/2020

Date registered

22/05/2020

Date last updated

13/07/2022

Date data sharing statement initially provided

22/05/2020

Date results information initially provided

13/07/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Partnering with General practitioners to Optimise Survivorship for PatiEnts with Lymphoma: A Phase II randomised controlled trial.

Scientific title

Partnering with General practitioners to Optimise Survivorship for PatiEnts with Lymphoma: A Phase II randomised controlled trial on effect of shared model of follow-up care on quality of life (The GOSPEL I Trial)

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1250-8246

Trial acronym

GOSPEL

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Lymphoma

Condition category

Condition code

Cancer

Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Cancer

Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Cancer

Hodgkin's

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Group 1 (The shared-care group):

Both acute post-treatment and observation follow-up patients will be offered 1 x 30-60 minute Nurse-led clinic within 10 weeks after the end of treatment and/or at least 2 weeks prior to the GP case-conference to: 1) provide survivorship patient education including a written survivorship booklet on “Living Well After Treatment – A guide for patients and families” published by Leukaemia Foundation; 2) treatment summary; 3) co-develop a Survivorship Care Plan (SCP) including SMART goals (using motivational interviewing and self-efficacy techniques); and 4) follow-up appointment schedule. A completed draft treatment summary and SCP will be provided to the GP.

Both acute post-treatment and observation follow-up patients will be offered 1 x 20-30 minute case-conference between specialist nurse and GP after the Nurse-led clinic to discuss intervention follow-up schedule, the draft SCP with the GP and negotiate GP role in facilitating SCP goals and surveillance activities. A completed SCP will then be forwarded to the GP and the patient.

After GP case conference, acute post-treatment follow-up patients will be offered 3 x GP appointments (at 3, 9 and 18 months) and 3 x Haematologist appointments (at 6, 12 and 24 months). All appointments will be of variable duration depending on patient need and clinician preference.

After GP case conference, observation follow-up (i.e., surveillance clinics) patients will be offered 2 x GP appointments (at 6 and 18 months) and 2 x Haematologist appointments (at 12 and 24 months). All appointments will be of variable duration depending on patient need and clinician preference.

All GP appointments will be to conduct surveillance activities (i.e., history and physical examination for B-symptoms and order and review of full blood count, urea and electrolytes, liver function tests and lactate dehydrogenase) and review the SCP, general health, and screening/management of comorbidities, psychosocial health cancer treatment toxicities, cancer-related symptoms; chronic disease management planning and allied health referrals. The GP will have direct telephone access to the specialist nurse in case of concerns or escalation for acute care review.

All Haematologist appointments will be to conduct surveillance activities (i.e., history and physical examination for B-symptoms and order and review of full blood count, urea and electrolytes, liver function tests and lactate dehydrogenase).

At 2 years, both acute post-treatment and observation follow-up patients will return to standard care practices (either discharge to GP or continued specialist surveillance).

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

Group 2 (Information Only)
Standard follow-up care plus a written survivorship booklet on “Living Well After Treatment – A guide for patients and families” published by Leukaemia Foundation. The current follow-up arrangement is a specialist-led model as determined by the treating Haematologist..

Control group

Active

Outcomes

Primary outcome [1]

Health-related quality of life as measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

Timepoint [1]

Measured at baseline, 6 months and 12 months.

Secondary outcome [1]

Patient experience of care as measured by Patient Assessment of Care for Chronic Conditions (PACIC-20)

Timepoint [1]

Measured at baseline, 6 months and 12 months.

Secondary outcome [2]

Symptom distress as measured by Memorial Symptom Assessment Scale (MSAS)

Timepoint [2]

Measured at Baseline, 6 months and 12 months

Secondary outcome [3]

Comorbidity burden as measured by The Charleston Comorbidity Index (CCI) supplemented with items from Self-Administered Comorbidity Questionnaire (SCQ)

Timepoint [3]

Measured at Baseline and 12 months

Secondary outcome [4]

Physical activity behaviours as measured by the Active Australia Survey

Timepoint [4]

Measured at Baseline, 6 months and 12 months

Secondary outcome [5]

Sedentary behaviours as measured by a single item of the International Physical Activity Questionnaire (IPAQ)

Timepoint [5]

Measured at Baseline, 6 months and 12 months

Secondary outcome [6]

Dietary intake behaviours as measured by two Short Dietary Questions from the National Nutrition Survey

Timepoint [6]

Measured at Baseline, 6 months and 12 months

Secondary outcome [7]

Financial distress as measured by 0-10 numerical analogue scale where 10 is "a great deal" and 0 is "none".

Timepoint [7]

Measured at Baseline, 6 months and 12 months

Secondary outcome [8]

Employment interference as measured by 0-10 numerical analogue scale where 10 is "a great deal" and 0 is "none".

Timepoint [8]

Measured at Baseline, 6 months and 12 months

Secondary outcome [9]

Satisfaction of care as measured by a 0-10 numerical analogue scale with 10 being "most satisfied", supplemented with short, structured qualitative questions.

Timepoint [9]

Measured at 12 months.

Secondary outcome [10]

Completed nurse-led clinic (Y/N) as per nurse record in research database (for Intervention group ; Arm 1 only)

Timepoint [10]

Measured retrospectively from baseline to 12 months.

Secondary outcome [11]

Cost-analysis as measured by hospital case mix data describing occasions of service including duration and indication and research nurse records in database and record of all resources required to conduct the intervention (e.g., staff, training, materials, communications, office space, utilities).

Timepoint [11]

Measured prospectively and retrospectively from Baseline to 12 months.

Secondary outcome [12]

Completed GP case conferencing (Y/N) as per nurse record in research database (for Intervention group ; Arm 1 only)

Timepoint [12]

Measured retrospectively from baseline to 12 months.

Secondary outcome [13]

Completed Survivorship Care Plan/components (Y/N) as per nurse record in research database (for Intervention group ; Arm 1 only)

Timepoint [13]

Measured retrospectively from baseline to 12 months.

Secondary outcome [14]

Number of hospital clinical encounters, unscheduled lymphoma clinic visits and rapid referrals back to acute care as per nurse record in research database (for Intervention group ; Arm 1 only)

Timepoint [14]

Measured retrospectively from baseline to 12 months.

Eligibility

Key inclusion criteria

Due to the varying follow-up requirements for patients with lymphoma, we will recruit 2 groups of patients who map to 2 distinct follow-up pathways:
- Group 1. Acute post-treatment follow-up: Patients with a pathologically confirmed diagnosis of aggressive or indolent lymphoma in the acute post-treatment phase (i.e., within three months of completion of chemotherapy); and
- Group 2. Observation follow-up (i.e., surveillance clinics): Patients with a pathologically confirmed diagnosis of indolent lymphoma followed up in the surveillance clinic and at least 2 years post-treatment or treatment naïve.

All participants must be:
- Men or women
- >/=18 years of age
- have an ECOG performance status <2
- be an ambulatory patient at the time of recruitment
- be able to nominate a GP to be involved in their follow-up
- have access to a telephone

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- the presence of severe mental, cognitive or physical conditions that would limit the patient’s ability to participate as per treating clinician.
- Lymphoma not in remission

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The allocation code will be kept in a sealed opaque envelope. Allocation will remain concealed from the research nurse and patient until after the patient is consented and baseline data collected.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation (using blocks of 4 and 8) will be conducted to assign participants to the control or intervention arms. To ensure equal distribution of patients with different follow-up schedules, patients will be stratified by diagnosis (NHL vs HL) and follow-up pathway (i.e., post-treatment vs surveillance clinic)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Not applicable

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Descriptive statistics will be used to report on feasibility and process-related elements (e.g., recruitment, intervention, retention rates) as well as clinical and resource outcomes. Preliminary effect size estimates for patient and resource use outcomes will be calculated following intention-to-treat principles using linear mixed models. Models will include group, time and their interaction and be adjusted by diagnosis and age. Balance of demographic variables between usual care and intervention group will be investigated using chi-square and t-test and will be included in the model if found to be both significantly associated with the outcome and confounding the intervention. Assumptions of all models (normality, linearity, homoscedasticity) will be examined using the residuals of the model and will be described using mean, median, skewness, kurtosis and plots such as histograms and QQ-plots. If assumptions are violated, models will be either bootstrapped or log transformation as appropriate.
Hospital resources and costs will be captured using casemix data to understand what resources are used by participants in the hospital system and whether they are different by group allocation. We will analyse resource and cost data using generalised linear models which are suitable for right skewness, are flexible and fit cost data well. This analysis will also assist in understanding the intervention delivery costs and provide data on feasibility of a larger scale full economic evaluation.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

4/01/2021

Actual

13/07/2020

Date of last participant enrolment

Anticipated

31/01/2022

Actual

17/05/2022

Date of last data collection

Anticipated

17/05/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Health Innovation, Investment and Research Office (HIIRO) Queensland Advancing Clinical Research Fellowships

Address [1]

Level 13, 33 Charlotte Street,
Brisbane QLD 4000

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Raymond Chan

Address

Division of Cancer Services
Level 2
199 Ipswich Road
Princess Alexandra Hospital
Woolloongabba
QLD 4102

School of Nursing
N Block Level 3 342
Victoria Park Road
Queensland University of Technology
Kelvin Grove
QLD 4059

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/03/2020

Approval date [1]

14/04/2020

Ethics approval number [1]

HREC/2020/QMS/61872

Summary

Brief summary

The purpose of this study is to test the feasibility of a care model involving haematologists and GPs for lymphoma follow-up care.

Who is it for?
You may be eligible for this study if you are aged 18 or older, and have lymphoma.

Study details
Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will receive standard follow-up (haematologist-led) care and information from Cancer Council Australia. The other group will undergo the share-care model. This involves a series of 20 to 60 minute appointments with specialist nurses, GPs and haematologists for up to 2 years.
As part of the study all participants will answer a series of questionnaires every 6 months for 12 months.

It is hoped this research will demonstrate the feasibility and usefulness of the new model of care which could influence future lympjhoma follow-up care.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Raymond Chan

Address

Country

Australia

Phone

+61 7 31387311

Fax

[email protected]

Contact person for public queries

Name

Prof Raymond Chan

Address

Country

Australia

Phone

+61 7 31387311

Fax

[email protected]

Contact person for scientific queries

Name

Prof Raymond Chan

Address

Country

Australia

Phone

+61 7 31387311

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	Partnering with general practitioners to optimize survivorship for patients with lymphoma: a phase II randomized controlled trial (the GOSPEL I trial).	2021	https://dx.doi.org/10.1186/s13063-020-04945-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically