Web-based cognitive rehabilitation intervention for cancer-related cognitive impairment in patients with lymphoma

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: 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. CONDITION: Cancer ‐ Lymphoma (non Hodgkin's lymphoma) ‐ High grade lymphoma lymphoma;Cancer related cognitive impairment; ; lymphoma ; Cancer related cognitive impairment Neurological ‐ Other neurological disorders PRIMARY OUTCOME: This trial’s primary outcome is to determine the feasibility of recruitment and appraise reasons for ineligibility. This will be assessed as a composite outcome. This will be assessed via the project operation database[Upon conclusion of the study; ] 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 SECONDARY OUTCOME: Adherence to the eReCog intervention assessed using data collected from the backend server.[Upon conclusion of study] Compliance with study measures at follow‐up assessed using data collected from the project operation database.[Upon conclusion of the study] Intrinsic motivation to perform the rehabilitation intervention assessed using the Intrinsic Motivation Inventory PROM. ; [Five to si Xweeks post‐baseline (one to two weeks post‐intervention for participants randomised to the intervention arm, T2). ] Objective assessment of cognitive functioning will be assessed via the Controlled Oral Word Association Test[Baseline and five to si Xweeks weeks post‐baseline (one to two weeks post‐intervention for participants randomised to the intervention arm, T2).] Objective assessment of cognitive functioning will be assessed via the Digit Span scale[Baseline and five to si Xweeks weeks post‐baseline (one to two weeks post‐intervention for participants randomised to the intervention arm, T2).] Objective assessment of cognitive functioning will be assessed via the Hopkins Verbal Learning Test[Baseline and five to si Xweeks weeks post‐baseline (one to two weeks post‐intervention for participants randomised to the intervention arm, T2).] Objective assessment of cognitive functioning will be assessed via the Stroop colour and word scale[Baseline and five to si Xweeks weeks post‐baseline (one to two weeks post‐intervention for participants randomised to the intervention arm, T2).] Objective assessment of cognitive functioning will be assessed via the Trail Making A & B scale[Baseline and five to si Xweeks weeks post‐baseline (one to two weeks post‐intervention for participants randomised to the intervention arm, T2).] Retention of participants at follow‐up assessed using data collected from the project operation database.[Upon completion of study] Subjective assessment of cognitive functioning will be assessed via the PROMIS Cognitive Function‐Short form 8a PROM[Baseline and five to si Xweeks weeks post‐baseline (one to two weeks post‐intervention for participants randomised to the intervention arm, T2).] Usability of eReCog assessed via the mHealth App Usability Questionnaire patient reported outcome measure (PROM) ; [Five to si Xweeks post‐baseline (one to two weeks post‐intervention for participants randomised to the intervention arm, T2). ]
Epistemonikos ID: 1c7c4b207f3d6447dffe878af442ea9bbecc0c8c
First added on: Aug 26, 2024