None listed
Conditions
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.
Interventions
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
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.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed