None listed
Conditions
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.
Interventions
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 add
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.
Sponsors
Macquarie University
Study design
Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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.
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).
Outcome results
None listed