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PROCOG: Investigating Cognitive Problems in Men with Prostate Cancer

Characterising prostate cancer patients undergoing androgen deprivation therapy: Is there a group of men more at risk of cognitive changes? A Cross-sectional Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001608853
Acronym
PROCOG
Enrollment
122
Registered
2021-11-25
Start date
2021-01-22
Completion date
2023-09-30
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 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.

Sponsors

Macquarie University
Lead SponsorUniversity

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Exclusion criteria

Receiving a diagnosis of dementia prior to commencing treatment for prostate cancer.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026