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Trial registered on ANZCTR


Registration number
ACTRN12619001649101
Ethics application status
Approved
Date submitted
6/11/2019
Date registered
26/11/2019
Date last updated
26/11/2019
Date data sharing statement initially provided
26/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive impairment in patients with lymphoma
Scientific title
A longitudinal feasibility study exploring cancer related cognitive impairment in patients with newly diagnosed aggressive lymphoma undergoing standard chemotherapy with curative intent.
Secondary ID [1] 299705 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 315057 0
Cancer related cognitive impairment 315058 0
Condition category
Condition code
Cancer 313387 313387 0 0
Hodgkin's
Cancer 313388 313388 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Mental Health 313483 313483 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This longitudinal, feasibility study sets out to explore the pattern of cancer related cognitive impairment in thirty patients with newly diagnosed aggressive lymphoma receiving standard therapy with curative intent, using validated questionnaires, neuropsychological testing, blood-cell inflammatory markers and neuroimaging over a period of eighteen months.
Intervention code [1] 315967 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321869 0
The main feasibility outcomes are recruitment, retention, compliance with study measures, acceptability and practicability of subjective and objective study measures. Recruitment data will be summarised using a rate and 95% confidence interval using the Poisson distribution. Compliance with assessments, as well as adherence and retention data will be summarised using a proportion and 95% confidence interval; the latter will be estimated using the Wilson method ( Brown et al 2001). Acceptability outcome will be explored by face-to-face participant burden interview. Open-ended questions will be used to seek participant input on modifications that could be made to improve acceptability of study assessments. The responses will be used to identify which components of study assessments were well received, which could be improved, and which were not acceptable.
Timepoint [1] 321869 0
There are three time points of evaluation:
• Time 1 – pre-treatment (treatment naïve)
• Time 2 – mid-treatment
• Time 3 – six to eight weeks post treatment completion
Participants will be followed longitudinally and assessed at three timepoints using objective and subjective measures. Each participant will be on study for up to seven months.
Secondary outcome [1] 376534 0
Patient reported outcomes
Continuous patient-reported outcomes include: EORTC QLQ-C30 CF, FACT-COG, CFQ, FACT-G, FACT-Fatigue, and PROMIS Emotional Distress-Depression 8b and -Anxiety 7a short forms. This is a composite outcome.
Descriptive statistics will also be used to summarise operational data on patient reported outcomes. Counts and percentages will be used to summarise missing data, including missing items and forms for patient-reported outcome measures. Patient-reported outcome measures will be scored according to author guidelines. Means, standard deviations and ranges will be used to summarise continuous outcomes at each time-point.
Analysis of patient-reported outcome data will be carried out by fitting a linear mixed model to each outcome separately using the ‘lme4’ package (Bates et al, 2019). Models will include a fixed effect for time and a random participant effect."



Timepoint [1] 376534 0
There are three time points of evaluation:
• Time 1 – pre-treatment (treatment naïve)
• Time 2 – mid-treatment
• Time 3 – six to eight weeks post treatment completion
Participants will be followed longitudinally and assessed at three timepoints using objective and subjective measures. Each participant will be on study for up to seven months.
Secondary outcome [2] 377170 0
Neuropsychological testing
Continuous neuropsychological testing outcomes include Stroop Colour and Word, Trail Making Test Part A and Trail Making Test Part B, Hopkins Verbal Learning Test-Revised –(HVLT-R), Controlled Oral Word Association (COWA) and Digit span (WAIS-R). This is a composite outcome.
Neuropsychological testing will be scored according to author guidelines. Descriptive statistics will also be used to summarise operational data and means, standard deviations and ranges will be used to summarise continuous outcomes at each time-point.
Analysis of neuropsychological testing data will be carried out by fitting a linear mixed model to each outcome separately using the ‘lme4’ package ( Bates et al, 2019). Models will include a fixed effect for time and a random participant effect."
Timepoint [2] 377170 0
There are three time points of evaluation:
• Time 1 – pre-treatment (treatment naïve)
• Time 2 – mid-treatment
• Time 3 – six to eight weeks post treatment completion
Participants will be followed longitudinally and assessed at three timepoints using objective and subjective measures. Each participant will be on study for up to seven months.
Secondary outcome [3] 377171 0
Neuroimaging
We will be using a Tukey-Kramer HSD test to establish longitudinal changes in regional tracer uptake as well as in cortical volumes and thickness over the course of the treatment and recovery. False discovery rate correction for multiple comparisons will be performed on the regional comparisons and correlations. This is a composite outcome.
Timepoint [3] 377171 0
There are three time points of evaluation:
• Time 1 – pre-treatment (treatment naïve)
• Time 2 – mid-treatment
• Time 3 – six to eight weeks post treatment completion
Participants will be followed longitudinally and assessed at three timepoints using objective and subjective measures. Each participant will be on study for up to seven months.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Age greater than or equal to 18 years
2. Newly diagnosed aggressive lymphoma that requires standard chemotherapy treatment with curative intent at Austin Health. Including:
• Hodgkin lymphoma
• Diffuse large B cell lymphoma
• Burkitt lymphoma
• Transformed follicular lymphoma
• Grade 3b follicular lymphoma
3. Able to read and comprehend English instructions.
4. Eastern Collaborative Oncology Group (ECOG) performance status less than or equal to 2

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Central Nervous System (CNS) lymphoma
2. Prior/planned cranial radiotherapy
3. An expected life expectancy < 12 months
4. Medical conditions that may compromise compliance or lead to prolonged hospitalisation
5. Documented history of or current substance abuse
6. Concurrent poorly controlled psychiatric illness.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics (including counts and percentages for nominal and crude-scale ordinal (<10 levels) valued variables; and means and standard deviations or medians and interquartile ranges, as appropriate, for continuous valued variables) will be used to summarise patient demographic and clinical characteristics. Descriptive statistics will also be used to summarise operational data on the use of patient reported outcomes, neuropsychological testing, laboratory tests and neuroimaging.
The main feasibility outcomes are recruitment, retention, compliance with study measures, acceptability and practicability of subjective and objective study measures.

Recruitment
Recruitment status
Recruiting
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] 15089 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 28387 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 304179 0
Commercial sector/Industry
Name [1] 304179 0
Celgene Pty Ltd
Address [1] 304179 0
15/60 City Road
Southbank Victoria 3006
Country [1] 304179 0
Australia
Funding source category [2] 304198 0
Hospital
Name [2] 304198 0
Olivia Newton-John Cancer Wellness and Research Centre Supportive Care PhD scholarship
Address [2] 304198 0
145 Studley Road
Heidelberg
Victoria 3084
Country [2] 304198 0
Australia
Primary sponsor type
Individual
Name
A/Prof Eliza Hawkes
Address
Austin Health
145 Studley Road
Heidelberg Victoria 3084
Country
Australia
Secondary sponsor category [1] 304410 0
None
Name [1] 304410 0
Address [1] 304410 0
Country [1] 304410 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304650 0
Austin Hospital HREC
Ethics committee address [1] 304650 0
Austin Health
145 Studley Road
Heidelberg Victoria 3084
Ethics committee country [1] 304650 0
Australia
Date submitted for ethics approval [1] 304650 0
01/09/2019
Approval date [1] 304650 0
04/10/2019
Ethics approval number [1] 304650 0

Summary
Brief summary
The purpose of this study is to assess the feasibility of collecting data on cognition over the course of treatment and recovery in patients with newly diagnosed aggressive lymphoma

Who is it for?
You may be eligible for this study if you are an adult who has been newly diagnosed with aggressive lymphoma, that is undergoing treatment at Austin Health.

Study details
All participants in this study will complete their usual treatment as prescribed by their doctor. Participants in this study will be assessed at three timepoints over the course of their treatment and recovery – one before treatment starts, one halfway, and one at the end of the treatment period. The assessment session will involve some tests to assess cognitive function and, in those participants willing to participate, a MRI brain scan and/or a PET/CT brain scan.

It is hoped that this research will help determine if a larger study looking at cognitive function during chemotherapy for lymphoma is possible, adding to an underexplored area of cancer research.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97726 0
Ms Priscilla Gates
Address 97726 0
Austin Health
145 Studley Road
Heidelberg Victoria 3084
Country 97726 0
Australia
Phone 97726 0
+61 417916969
Fax 97726 0
Email 97726 0
priscilla.gates@austin.org.au
Contact person for public queries
Name 97727 0
Ms Priscilla Gates
Address 97727 0
Austin Health
145 Studley Road
Heidelberg Victoria 3084
Country 97727 0
Australia
Phone 97727 0
+61 417916969
Fax 97727 0
Email 97727 0
priscilla.gates@austin.org.au
Contact person for scientific queries
Name 97728 0
Ms Priscilla Gates
Address 97728 0
Austin Health
145 Studley Road
Heidelberg Victoria 3084
Country 97728 0
Australia
Phone 97728 0
+61 417916969
Fax 97728 0
Email 97728 0
priscilla.gates@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
This study is being undertaken as part of a PhD ( Nursing) at the University of Melbourne. After publication of findings de-identified data will be made available upon request.
When will data be available (start and end dates)?
Data collection will complete in April 2021. On completion of study and after publication of findings de-identified data will be made available upon request. No end date is determined.
Available to whom?
de-identified data will be made available to researchers who provide a methodologically sound proposal on case-by-case basis at the discretion of Primary Investigator
Available for what types of analyses?
Subject to approvals by Principal Investigator
How or where can data be obtained?
Access subject to approvals by Principal Investigator: eliza.hawkes@austin.org.au and Student Investigator(study contact) Priscilla Gates: priscilla.gates@austin.org.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results