Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001608853
Ethics application status
Approved
Date submitted
18/10/2021
Date registered
25/11/2021
Date last updated
28/08/2023
Date data sharing statement initially provided
25/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
PROCOG: Investigating Cognitive Problems in Men with Prostate Cancer
Scientific title
Characterising prostate cancer patients undergoing androgen deprivation therapy: Is there a group of men more at risk of cognitive changes? A Cross-sectional Study
Secondary ID [1] 305557 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PROCOG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 323950 0
Cognitive problems 323951 0
Condition category
Condition code
Cancer 321468 321468 0 0
Prostate
Mental Health 321469 321469 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 321666 321666 0 0
Anxiety
Mental Health 321667 321667 0 0
Depression
Mental Health 321668 321668 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
The cross-sectional survey aims to investigate the sociodemographic, medical, and intra- and interpersonal characteristics of men with prostate cancer experiencing cognitive changes following hormone therapy. We also aim to examine in-depth the nature and impact of hormone therapy-associated cognitive changes on these men’s and their partner’s lives and the types of cognitive change.

The participants will be required to fill out a single 20-30 minute online survey, which they can access using the following link: https://redcap.link/PROCOG

The following outcomes will be assessed:
1. Demographic, treatment-related and medical details
2. The Functional Assessment of Cancer Therapy- Prostate (FACT-P)
3. The Functional Assessment of Cancer Therapy-Cognitive Subscale (FACT-cog, version 3)
4. Cognitive Functioning Scale from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
5. The Fear of Cancer Recurrence-short form (FCR4)
6. A brief dietary questionnaire developed by Dr. Heather Francis measuring the number of times someone consumes a type of food (e.g., vegetables, fruits, etc.) in a week.
7. The 6-item version of Need for Cognition Scale (NCS-6)
8. The International Physical Activity Questionnaire (IPAQ)
9. The short-form version of the Depression Anxiety Stress Scales (DASS-21)
10. The State Self-Compassion Scale – Short Form

Participants have the choice to sign up for an optional 20-60 minute interview with a member of the research team. The interview will be conducted either over the phone or via videoconferencing.
Intervention code [1] 321954 0
Diagnosis / Prognosis
Comparator / control treatment
The study will compare the responses between men:
1. without prostate cancer
2. with prostate cancer on 'watchful waiting' or 'active surveillance
3. with prostate cancer on homornal treatments (e.g., androgen deprivation therapy)
Control group
Active

Outcomes
Primary outcome [1] 329265 0
The Functional Assessment of Cancer Therapy-Cognitive Subscale (FACT-cog, version 3)
Timepoint [1] 329265 0
At the time of enrolment
Primary outcome [2] 329442 0
Cognitive Functioning Scale from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [2] 329442 0
At the time of enrolment
Secondary outcome [1] 401949 0
The Functional Assessment of Cancer Therapy- Prostate (FACT-P)
Timepoint [1] 401949 0
At the time of enrolment
Secondary outcome [2] 402635 0
The Fear of Cancer Recurrence-short form
Timepoint [2] 402635 0
At the time of enrolment
Secondary outcome [3] 402636 0
A brief dietary questionnaire developed by Dr. Heather Francis measuring the number of times someone consumes a type of food (e.g., vegetables, fruits, etc.) in a week.
Timepoint [3] 402636 0
At the time of enrolment
Secondary outcome [4] 402637 0
The 6-item version of Need for Cognition Scale (NCS-6)
Timepoint [4] 402637 0
At the time of enrolment
Secondary outcome [5] 402638 0
The International Physical Activity Questionnaire (IPAQ)
Timepoint [5] 402638 0
At the time of enrolment
Secondary outcome [6] 402639 0
The short-form version of the Depression Anxiety Stress Scales (DASS-21)
Timepoint [6] 402639 0
At the time of enrolment

Eligibility
Key inclusion criteria
Men aged 18 or older, who are able to read and speak English sufficiently well to respond to written questions and provide consent and have access to an electronic device will be included for the study. There will be three groups of participants:
i) Men diagnosed with prostate cancer, who are currently undergoing hormonal treatments (androgen deprivation therapy);
ii) Men diagnosed with prostate cancer, who have are on ‘watchful waiting’;
iii) Age-matched men without a prostate cancer diagnosis.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Receiving a diagnosis of dementia prior to commencing treatment for prostate cancer.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Data will be analysed using Latent Profile Analysis to determine whether there are distinct biopsychosocial profiles. ANCOVA or Chi-squared analysis will be used to determine whether there are differences between the identified profiles differ across several biopsychosocial characteristics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/01/2021
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
150
Accrual to date
122
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 20777 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 35588 0
2109 - Macquarie Park

Funding & Sponsors
Funding source category [1] 309923 0
University
Name [1] 309923 0
Macquarie University
Country [1] 309923 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road
North Ryde, NSW, 2109
Australia
Country
Australia
Secondary sponsor category [1] 310976 0
None
Name [1] 310976 0
Address [1] 310976 0
Country [1] 310976 0
Other collaborator category [1] 282023 0
Other Collaborative groups
Name [1] 282023 0
The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Address [1] 282023 0
Lifehouse
Level 6
119-143 Missenden Road,
Camperdown NSW 2050
Country [1] 282023 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309641 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 309641 0
Balaclava Rd
Macquarie Park
NSW 2109
Ethics committee country [1] 309641 0
Australia
Date submitted for ethics approval [1] 309641 0
14/08/2020
Approval date [1] 309641 0
27/08/2020
Ethics approval number [1] 309641 0
52020611919011

Summary
Brief summary
This observational study aims to investigate the sociodemographic, medical, and intra- and interpersonal characteristics of men with prostate cancer experiencing cognitive changes following hormone therapy. We also aim to examine in-depth the nature and impact of hormone therapy-associated cognitive changes on these men’s and their partner’s lives and the types of cognitive change. This will be compared to individuals with prostate cancer who are undergoing ‘watchful waiting’ or ‘active surveillance', and individuals without prostate cancer.

Who is it for?
You may be eligible for this study if you are a male aged 18 years or older, with or without prostate cancer. If you have prostate cancer, you may be eligible if you are currently undergoing hormone therapy, or are undergoing ‘watchful waiting’ or ‘active surveillance’.

Study details
All enrolled participants will be asked to complete a number of questionnaires regarding quality of life, cognition, physical activity, diet, and mental health. It is expected that the online survey will take approximately 20-30 minutes to complete in total. Participants will be required to complete the survey only once.

Participants and their loved ones will also have the choice to sign up for an optional interview with a research team member to explore their experiences in more depth. This interview will take around 20-60 minutes. It can be either conducted over the phone or via videoconferencing. Participants will be reimbursed for the interview.

It is hoped that with the findings obtained from this study, this information will help clinicians identify patients who may be at risk of cognitive changes from hormone therapy. Moreover, the findings will aid the development of a neuropsychological intervention to support these patients and their families with managing the cognitive changes they are experiencing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114874 0
Prof Kerry Sherman
Address 114874 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
Country Australia
Country 114874 0
Australia
Phone 114874 0
+61 2 9850 6874
Fax 114874 0
Email 114874 0
kerry.sherman@mq.edu.au
Contact person for public queries
Name 114875 0
Prof Kerry Sherman
Address 114875 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
Country Australia
Country 114875 0
Australia
Phone 114875 0
+61 2 9850 6874
Fax 114875 0
Email 114875 0
kerry.sherman@mq.edu.au
Contact person for scientific queries
Name 114876 0
Prof Kerry Sherman
Address 114876 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
Country Australia
Country 114876 0
Australia
Phone 114876 0
+61 2 9850 6874
Fax 114876 0
Email 114876 0
kerry.sherman@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
We do not have permission from the HREC to provide these data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13617Study protocol  lorna.huang@hdr.mq.edu.au 382954-(Uploaded-18-10-2021-11-09-51)-Study-related document.pdf
13618Informed consent form  lorna.huang@hdr.mq.edu.au 382954-(Uploaded-18-10-2021-11-10-52)-Study-related document.pdf
13619Ethical approval  lorna.huang@hdr.mq.edu.au 382954-(Uploaded-18-10-2021-11-11-08)-Study-related document.pdf



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.