Telehealth Program to Prevent Cancer and Chemotherapy-related Cognitive Impairment.
A Telehealth-based Cognitive-adaptive Training for Women With Breast Cancer in Risk to Suffer Cancer and Chemotherapy-related Cognitive Impairment: a Randomized Controlled Trial.
1 other identifier
interventional
98
1 country
1
Brief Summary
The present randomized controlled trial has the main objective to study the effects of a videoconferenced occupational therapy program in preventing cancer and chemotherapy-related cognitive impairment and other health outcomes, as well as in improving quality of live and occupational performance of women undergoing chemotherapy for breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2020
CompletedFirst Submitted
Initial submission to the registry
February 21, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedDecember 11, 2023
December 1, 2023
4.2 years
February 21, 2021
December 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective cognitive Function:
The primary outcome will be assessed with the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess the subjective cognitive functioning.
Participants will be followed over 6 months
Secondary Outcomes (8)
Objective Cognitive Function: Attention
Participants will be followed over 6 months
Objective Cognitive Function: Verbal Memory
Participants will be followed over 6 months
Objective Cognitive Function: Working Memory and Processing Speed
Participants will be followed over 6 months
Psychological status
Participants will be followed over 6 months
Cancer-Related Fatigue
Participants will be followed over 6 months.
- +3 more secondary outcomes
Study Arms (2)
e-OTCAT
EXPERIMENTALThe experimental group will receive the e-OTCAT program that consists of a 12-week videoconference-based occupational therapy intervention at the same time women with breast cancer receive chemotherapy.
Control Group
OTHERAt the beginning of chemotherapy, the participants allocated to the control group will only receive an educational handbook containing information about most frequent side-effects of cancer and cancer treatments, plus standard care for these patients.
Interventions
The e-OTCAT program consists of a combination of cognitive training in terms of attention, memory and processing speed; and adaptive training based on metacognition and cognitive-behavioral strategies (psycho-education, relaxation techniques training, stress management, energy conservation techniques, time management, etc.). This program also includes homework exercises consisting of a handbook of paper-and-pencil exercises, a cognitive training mobile app, and the practice of strategies seen in adaptive training sessions.
At the beginning of chemotherapy, the participants will receive an educational handbook containing information about most frequent side-effects of cancer and cancer treatments, plus standard care.
Eligibility Criteria
You may qualify if:
- Female with breast cancer who are going to start chemotherapy
- Stage I-III breast cancer
- No evidence of disease at time of screening
- Must be able to speak, read and write Spanish well to complete written and verbal assessment, neurocognitive tests and study tasks
- Must have basic phone skills
You may not qualify if:
- History of neurological disorder with cognitive symptoms (i.e., Parkinson's disease, Alzheimer disease, seizure disorder, multiple sclerosis, etc.)
- History of psychiatric disorder such as mental retardation, bipolar disorder, schizophrenia, etc.
- History of traumatic brain injury with ≥ 30' of consciousness or cognitive sequelae as per self-report or as documented in the medical record
- Prior history of cancer or secondary diagnosis of cancer
- Prior history of chemotherapy
- A hearing or visual deficit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Granada
Granada, 18016, Spain
Related Publications (1)
Gonzalez-Santos A, Lopez-Garzon M, Sanchez-Salado C, Postigo-Martin P, Lozano-Lozano M, Galiano-Castillo N, Fernandez-Lao C, Castro-Martin E, Gallart-Aragon T, Legeren-Alvarez M, Gil-Gutierrez R, Martin-Martin L. A Telehealth-Based Cognitive-Adaptive Training (e-OTCAT) to Prevent Cancer and Chemotherapy-Related Cognitive Impairment in Women with Breast Cancer: Protocol for a Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Jun 10;19(12):7147. doi: 10.3390/ijerph19127147.
PMID: 35742400DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer, PhD researcher and investigator
Study Record Dates
First Submitted
February 21, 2021
First Posted
March 5, 2021
Study Start
October 31, 2020
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
December 11, 2023
Record last verified: 2023-12