Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000705684
Ethics application status
Approved
Date submitted
5/06/2023
Date registered
30/06/2023
Date last updated
20/07/2023
Date data sharing statement initially provided
30/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Web-based cognitive rehabilitation intervention for cancer-related cognitive impairment in patients with lymphoma
Scientific title
Web-based cognitive rehabilitation intervention for cancer-related cognitive impairment following chemotherapy for aggressive lymphoma: a randomised pilot trial.
Secondary ID [1] 309829 0
Nil Known
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
lymphoma 330256 0
Cancer related cognitive impairment 330257 0
Condition category
Condition code
Cancer 327120 327120 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Neurological 327121 327121 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After the baseline assessment, participants will be randomised 1:1 to either the intervention or usual care. Randomisation will be performed using a computer-generated block allocation sequence and will be carried out by a member of the research team not involved in the assessment of participants.
Intervention group. Responding to Cognitive Concerns (eReCog) is a web-based cognitive rehabilitation program, based on the principles of cognitive behavioural therapy. The interactive program offers adult cancer survivors psychoeducation on cognitive dysfunction associated with cancer and cancer treatment, skills training for improving memory and attention, relaxation training, discussion questions and optional weekly homework tasks. Modules take approximately 30 to 60 minutes, and participants are expected to complete one module per week over four weeks.
Module topics are (1) aging, health, cancer and cognitive functioning, (2) memory, (3) attention, and (4) emotions, fatigue and cognition. Each module has a fixed number of pages, which participants progress through consecutively until reaching the end of the module. There is a tracking bar indicating the total number of pages in the module that allows participants to monitor their progress. Participants will be sent weekly reminder emails if a task is not completed. Online facilitation of the program will be carried out by a Research Assistant, who is not involved in the assessment of participants.
Intervention code [1] 326263 0
Rehabilitation
Comparator / control treatment
Usual care: At baseline, participants in both study arms will receive a factsheet produced by Cancer Council ‘Understanding Changes in Thinking and Memory: A guide for people affected by cancer’. On completion of the study, participants assigned to usual care will be given a list of brain training websites they may wish to try.
Control group
Active

Outcomes
Primary outcome [1] 334992 0
This trial’s primary outcome is to determine the feasibility of recruitment and appraise reasons for ineligibility. This will be assessed as a composite outcome. This will be assessed via the project operation database
Timepoint [1] 334992 0
Upon conclusion of the study
Secondary outcome [1] 422908 0
Adherence to the eReCog intervention assessed using data collected from the backend server.
Timepoint [1] 422908 0
Upon conclusion of study
Secondary outcome [2] 422909 0
Usability of eReCog assessed via the mHealth App Usability Questionnaire patient reported outcome measure (PROM)
Timepoint [2] 422909 0
Five to six weeks post-baseline (one to two weeks post-intervention for participants randomised to the intervention arm, T2).
Secondary outcome [3] 422910 0
Compliance with study measures at follow-up assessed using data collected from the project operation database.
Timepoint [3] 422910 0
Upon conclusion of the study
Secondary outcome [4] 422911 0
Retention of participants at follow-up assessed using data collected from the project operation database.
Timepoint [4] 422911 0
Upon completion of study
Secondary outcome [5] 422912 0
Intrinsic motivation to perform the rehabilitation intervention assessed using the Intrinsic Motivation Inventory PROM.
Timepoint [5] 422912 0
Five to six weeks post-baseline (one to two weeks post-intervention for participants randomised to the intervention arm, T2).
Secondary outcome [6] 422913 0
Objective assessment of cognitive functioning will be assessed via the Stroop colour and word scale
Timepoint [6] 422913 0
Baseline and five to six weeks weeks post-baseline (one to two weeks post-intervention for participants randomised to the intervention arm, T2).
Secondary outcome [7] 423127 0
Objective assessment of cognitive functioning will be assessed via the Trail Making A & B scale
Timepoint [7] 423127 0
Baseline and five to six weeks weeks post-baseline (one to two weeks post-intervention for participants randomised to the intervention arm, T2).
Secondary outcome [8] 423128 0
Objective assessment of cognitive functioning will be assessed via the Hopkins Verbal Learning Test
Timepoint [8] 423128 0
Baseline and five to six weeks weeks post-baseline (one to two weeks post-intervention for participants randomised to the intervention arm, T2).
Secondary outcome [9] 423129 0
Objective assessment of cognitive functioning will be assessed via the Controlled Oral Word Association Test
Timepoint [9] 423129 0
Baseline and five to six weeks weeks post-baseline (one to two weeks post-intervention for participants randomised to the intervention arm, T2).
Secondary outcome [10] 423130 0
Objective assessment of cognitive functioning will be assessed via the Digit Span scale
Timepoint [10] 423130 0
Baseline and five to six weeks weeks post-baseline (one to two weeks post-intervention for participants randomised to the intervention arm, T2).
Secondary outcome [11] 423132 0
Subjective assessment of cognitive functioning will be assessed via the PROMIS Cognitive Function-Short form 8a PROM
Timepoint [11] 423132 0
Baseline and five to six weeks weeks post-baseline (one to two weeks post-intervention for participants randomised to the intervention arm, T2).

Eligibility
Key inclusion criteria
• Aged 18 years of age or older
• Perceived reduction in cognitive functioning based on responses to a single-item Cognitive Change Score
• Completed chemotherapy for aggressive lymphoma within the past five years and are in remission.
• Have access to a laptop or desktop computer with internet.
• Have an active email account.
• Able to read and comprehend English instructions.
• Eastern Cooperative Oncology Group (ECOG) performance <2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Central nervous system (CNS) lymphoma
• Prior cranial radiotherapy
• Prior CAR T -cell therapy or allograft
• An expected life expectancy <12 months
• Medical conditions that compromise compliance or lead to prolonged hospitalisation
• Documented history of/or current substance abuse
• Concurrent poorly controlled psychiatric illness

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)
After the baseline assessment, participants will be randomised 1:1 to either the intervention or usual care. Randomisation will be performed using a computer-generated block allocation sequence and will be carried out by a member of the research team not involved in the assessment of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1:1 to either the intervention or usual care. Randomisation will be performed using a computer-generated block allocation sequence and will be carried out by a member of the research team not involved in the assessment of participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis
Analysis will include all available data and be performed in R (reference index version 4.2.1 or higher). Neuropsychological tests and PROMs will be scored according to author guidelines. Values for missing tests and measures will not be imputed.
Missing data
Counts and percentages will be used to summarise missing data, including missing items and forms on neuropsychological tests and patient-reported outcome measures, at baseline and follow-up.
Sample characteristics
Descriptive statistics (counts and percentages, means and standard deviations, or medians and interquartile ranges, as appropriate) will be used to summarise demographic and clinical characteristics by study arm.
Feasibility outcomes
Recruitment data will be summarised using a rate and 95% confidence interval using the Poisson distribution. Adherence, retention, usability, intrinsic motivation, and compliance with study measures data will be summarised using a proportion and 95% confidence interval using the Wilson method.
Potential efficacy
Descriptive statistics (means and standard deviations) will be used to summarise test/(sub)scale scores at each assessment by study arm. Differences in (sub)scale scores at follow-up will be summarised using a mean and 95% confidence interval. If appropriate, analysis of covariance will be used to estimate differences between study arms adjusting for participants’ baseline scores.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
20/07/2023
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
2/12/2024
Actual
Sample size
Target
38
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24866 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 40514 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 314014 0
University
Name [1] 314014 0
Deakin University
Country [1] 314014 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan st
Melbourne 3000
Victoria
Country
Australia
Secondary sponsor category [1] 315904 0
None
Name [1] 315904 0
Address [1] 315904 0
Country [1] 315904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313151 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 313151 0
305 Grattan St
Melbourne 3000
Victoria
Ethics committee country [1] 313151 0
Australia
Date submitted for ethics approval [1] 313151 0
08/05/2023
Approval date [1] 313151 0
07/06/2023
Ethics approval number [1] 313151 0

Summary
Brief summary
This study is investigating the feasibility of a web-based cognitive rehabilitation program called Cognitive Concerns(eReCog) to address cancer-related cognitive impairment.

Who is it for?
You may be eligible for this study if you are an adult who has completed chemotherapy for aggressive lymphoma within the past five years and are in remission, and have perceived reductions in cognitive functioning.

Study details
Participants will be randomly assigned to either the intervention or control group. Those in the intervention group will receive access to an online program containing 4 modules on strategies to address cognitive dysfunction, which are estimated to take 30-60 minutes each. Those in the control group will receive a factsheet on cancer-related cognitive impairment and a list of suggested brain training websites. Participants will be asked to complete measures on the usability of the program and changes in their cognition.

It is hoped that information from this study will inform a future, larger trial to test the effectiveness of a novel intervention to improve cognitive outcomes and quality of life in cancer patients following treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127170 0
A/Prof Michael Dickinson
Address 127170 0
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne 3000
Victoria
Country 127170 0
Australia
Phone 127170 0
+61417916969
Fax 127170 0
Email 127170 0
[email protected]
Contact person for public queries
Name 127171 0
Dr Priscilla Gates
Address 127171 0
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne 3000
Victoria
Country 127171 0
Australia
Phone 127171 0
+61417916969
Fax 127171 0
Email 127171 0
[email protected]
Contact person for scientific queries
Name 127172 0
Dr Priscilla Gates
Address 127172 0
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne 3000
Victoria
Country 127172 0
Australia
Phone 127172 0
+61417916969
Fax 127172 0
Email 127172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
On completion of study, de-identified individual participant data of published results only will be will be made available upon request.
When will data be available (start and end dates)?
Data collection will complete in December 2024. 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/Study contact Priscilla Gates: [email protected]


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.