Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000946617
Ethics application status
Approved
Date submitted
7/08/2023
Date registered
1/09/2023
Date last updated
10/05/2024
Date data sharing statement initially provided
1/09/2023
Date results information initially provided
10/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Online Group Sessions on Cognitive Functioning in Men with Prostate Cancer
Scientific title
Codesigned Online Group Cognitive Rehabilitation for Prostate Cancer Survivors Experiencing Cognitive Changes from Hormonal Treatments: Series of Single-Case Experimental Designs
Secondary ID [1] 310322 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 331041 0
cognitive difficulties 331042 0
Condition category
Condition code
Cancer 327837 327837 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For phase 1: A focus group to obtain feedback on the content and delivery of the intervention.
- Participants will be provided with an adapted version of a cognitive rehabilitation intervention (i.e., Responding to Cognitive Concerns [ReCog]) manual that was designed specifically for adult cancer survivors who have completed primary treatment (this is not a readily available resource). The program incorporates principles of cognitive behavioural therapy (CBT) and cognitive rehabilitation to address typical difficulties reported by cancer patients related to their cognition, such as difficulties with memory, attention, executive functioning and fatigue. The program entails psychoeducation, discussions and interactive activities.
- Participants are expected to spend no more than 1 hour familiarising themselves with the intervention content in their own time and share their feedback in a 2-hour online focus group facilitated by members of the research team.
- The focus group will consist of 6 participants and 2 research team members.
- More information can be found using this link: https://redcap.link/FocusGroupPROCOG
- Phase one will occur a few months prior to phase 2 to ensure there is adequate time for any changes to the manual to be reviewed by Human Research Ethics team at Macquarie University.

For phase 2: A 4-week online group cognitive rehabilitation program.
- Eligible participants will be provided with a participants handbook for a cognitive rehabilitation intervention, codesigned with prostate cancer patients (i.e., an adapted version of the Responding to Cognitive Concerns [ReCog] manual).
- Participation involved attending weekly 2-hour sessions (with a ~15 min break in-between) via telehealth over 4 weeks as well as completing 4 assessments (less than 1 hour long each): 3 to 5 weeks before the program starts, within 1 week of the program starting, within 1 week of the program ending and 3 weeks after the program ends. They will also be required to complete a 2-minute survey weekly for 10-12 weeks.
- There will be a maximum of 6 participants in the group.
- The intervention will be delivered by a registered psychologist undergoing a neuropsychology registrar program.
- A fidelity checklist will used to monitor adherence to the intervention
- More information can be found using this link: https://redcap.link/GroupPROCOG

Seperate cohorts are required for phase 1 and phase 2.


Single-case experimental designs (SCED) refer to experimental methodologies designed to assess the impact of an intervention on a limited number of participants. These designs involve repeated measurements, the sequential introduction of an intervention and specialized data analysis techniques such as visual analysis and specific statistical methods. We will be using the multiple-baseline design whereby participants will be randomised to a baseline period between 3 to 5 weeks.
Intervention code [1] 326700 0
Rehabilitation
Intervention code [2] 326720 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335686 0
Phase 1: focus group
- qualitative feedback on the content and delivery of the intervention
Timepoint [1] 335686 0
One online 2-hour focus group session that will be recorded and transcribed.
Primary outcome [2] 335795 0
Phase 2: Series of SCED
- Acceptability of the group intervention through a semi-structured interview.
Questions for the semi-structured interview were informed by Sekhon et al.’s (2017) theoretical framework of acceptability, comprising of seven constructs: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Each participant will be interview individually.
Timepoint [2] 335795 0
The acceptability of intervention activities will be assessed by an exit feedback interview following the end of the intervention program (i.e., a week or two following the 4-week program).
Primary outcome [3] 335796 0
Phase 2: Series of SCED
The feasibility of the intervention will be measured by participant attendance to session (i.e., attendance rates of 70%), using a log of attendence.
Timepoint [3] 335796 0
Weekly record kept by the facilitator over the 4-week intervention period.
Secondary outcome [1] 425183 0
Changes to perceived cognitive functioning will be measured using the 18-item Perceived Cognitive Impairment (PCI18) scale from the Functional Assessment of Cancer Therapy-Cognitive Subscale (FACT-cog, version 3; Wagner et al., 2009) and the PROMIS 8-item Cognitive Functioning Scale (PROMIS CF-SF-8a; Lai et al., 2014).
Timepoint [1] 425183 0
Weekly for 10-12 weeks from baseline, throughout the intervention and post-intervention.
Secondary outcome [2] 425188 0
Brief cognitive testing over videoconferencing.

Following International Cancer and Cognition Task Force (ICCTF) guidelines the following tests will be used:
- Hopkins Verbal Learning Test-Revised (HVLT-R; Benedict, 1998)
- Controlled Oral Word Association (COWA) of the Multilingual Aphasia Examination (Benton et al., 1989)
- Oral version of the Symbol Digit Modalities Test (SDMT; Smith, 1982) to measure speed of information processing.
Timepoint [2] 425188 0
Pre- and post-intervention (i.e., within one week starting the intervention and within one week after completing the intervention).
Secondary outcome [3] 425189 0
Goal attainment scaling
Timepoint [3] 425189 0
-baseline (3-5 weeks prior to the intervention)
-pre-intervention (within one week starting the intervention)
- post-intervention (within one week after completing the intervention
- follow-up (3 weeks post-intervention)
Secondary outcome [4] 425668 0
9-question Patient Health Questionnaire
Timepoint [4] 425668 0
-baseline (3-5 weeks prior to the intervention)
-pre-intervention (within one week starting the intervention)
- post-intervention (within one week after completing the intervention
- follow-up (3 weeks post-intervention)
Secondary outcome [5] 425669 0
7-item PROMIS Fatigue - Short Form
Timepoint [5] 425669 0
-baseline (3-5 weeks prior to the intervention)
-pre-intervention (within one week starting the intervention)
- post-intervention (within one week after completing the intervention
- follow-up (3 weeks post-intervention)
Secondary outcome [6] 425670 0
PROMIS Self-efficacy for Managing Chronic Conditions – Short form
Timepoint [6] 425670 0
-baseline (3-5 weeks prior to the intervention)
-pre-intervention (within one week starting the intervention)
- post-intervention (within one week after completing the intervention
- follow-up (3 weeks post-intervention)
Secondary outcome [7] 425932 0
PRIMARY OUTCOME: number of hours involved in running the program (i.e., bookings, sessions preparation, session run time, follow-up, assessments).
Timepoint [7] 425932 0
Weekly record kept by the facilitator for 10-12 weeks from baseline, throughout the intervention and 3 weeks post-intervention.
Secondary outcome [8] 426217 0
PRIMARY OUTOME: adherence to homework activities (i.e., 70%)
Timepoint [8] 426217 0
Weekly record kept by the facilitator over the 4-week intervention period.

Eligibility
Key inclusion criteria
The study will recruit men who:
• have subjective concerns about cognitive functioning;
• are currently receiving hormone therapy for prostate cancer;
• have completed major treatments (i.e., surgery, chemotherapy & radiotherapy) at least 3 months prior or not have had these treatments;
• over the age of 18;
• live in Australia;
• able to communicate and comprehend English competently.
• have access to a telephone and computer with internet access, microphone, and webcam.
• have completed pre-intervention assessments after being screened for eligibility.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men with the characteristics below will be excluded from the study:
• history of or current neurological illness that significantly impacts cognition (e.g., stroke, multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, epilepsy, significant head injury, etc.);
• reported active substance or alcohol dependence issues that would interfere with study participation;
• known history of primary or secondary CNS tumour (with the exception of diagnoses of skin cancer, carcinoma in situ or solid malignancies more than 5 years ago and not treated with chemotherapy);
• history of intracranial radiotherapy or intrathecal chemotherapy;
• significant uncontrolled psychiatric condition that would prevent participants from completing the intervention (e.g., psychosis).

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/09/2023
Actual
1/10/2023
Date of last participant enrolment
Anticipated
30/04/2024
Actual
20/12/2023
Date of last data collection
Anticipated
30/06/2024
Actual
23/04/2024
Sample size
Target
12
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25695 0
New Zealand
State/province [1] 25695 0

Funding & Sponsors
Funding source category [1] 314528 0
University
Name [1] 314528 0
Macquarie University
Country [1] 314528 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road
North Ryde, NSW, 2109
Australia
Country
Australia
Secondary sponsor category [1] 316478 0
None
Name [1] 316478 0
Address [1] 316478 0
Country [1] 316478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313570 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 313570 0
Balaclava Rd
Macquarie Park
NSW 2109
Ethics committee country [1] 313570 0
Australia
Date submitted for ethics approval [1] 313570 0
07/08/2023
Approval date [1] 313570 0
08/08/2023
Ethics approval number [1] 313570 0
Reference No:520231081852481

Summary
Brief summary
Cognitive changes are common in prostate cancer survivors after starting hormonal treatments. This study aims to investigate the feasibility and effectiveness of an online group cognitive rehabilitation program for these survivors.

Who is it for?
You may be eligible for the cognitive online group intervention if you are male, aged 18 years or over, and are currently receiving hormone therapy for prostate cancer.

Study details
This study will be conducted in two parts. Participants who choose to enrol in the first part will be presented with an outline of the proposed cognitive rehabilitation program.

Participants in part 1 will be asked to discuss the proposed program in an online focus group of up to 6 participants (and 2 research team members) . Participants will be asked to spend no more than 1 hour reading through program material to familiarise themselves with the content and then attend a 2-hour online focus group. Feedback provided by the participants in part 1 will be used to refine the proposed cognitive rehabilitation program.

In the second part, participants who choose to enrol will be given access to the final online cognitive rehabilitation program. The program will be run weekly over a 4 week period. Topics to be covered in the program include how to manage fatigue and difficulties with memory, attention and other cognitive abilities. There will be pre- and post-program assessments as well as questionnaires to compare prior, throughout and after the program.

It is hoped this research will determine whether a new online cognitive rehabilitation program has a positive impact on the cognitive function of prostate cancer survivors who are undergoing hormonal treatments. If this study shows promise, the rehabilitation program may be expanded so that a larger number of prostate cancer survivors may take part.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128586 0
Prof Kerry Sherman
Address 128586 0
School of Psychological Sciences, Faculty of Medicine, Health and Human SciencesMacquarie UniversityBalaclava RoadNorth Ryde, NSW, 2109Australia
Country 128586 0
Australia
Phone 128586 0
+61 2 9850 6874
Fax 128586 0
Email 128586 0
kerry.sherman@mq.edu.au
Contact person for public queries
Name 128587 0
Ms Lorna Huang
Address 128587 0
School of Psychological Sciences, Faculty of Medicine, Health and Human Sciences Macquarie UniversityBalaclava RoadNorth Ryde, NSW, 2109Australia
Country 128587 0
Australia
Phone 128587 0
+61 2 9850 6874
Fax 128587 0
Email 128587 0
lorna.huang@hdr.mq.edu.au
Contact person for scientific queries
Name 128588 0
Ms Lorna Huang
Address 128588 0
School of Psychological Sciences, Faculty of Medicine, Health and Human Sciences Macquarie UniversityBalaclava RoadNorth Ryde, NSW, 2109Australia
Country 128588 0
Australia
Phone 128588 0
+61 2 9850 6874
Fax 128588 0
Email 128588 0
lorna.huang@hdr.mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given the series of single-case experimental design, participant data will be reported in the paper itself if publication occurs.


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.