Clinical trial NCT04783402: Telehealth Program to Prevent Cancer and Chemotherapy-related Cognitive Impairment.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Neoplasms
Keywords: Chemotherapy
Occupational Therapy
Quality of Life
Cognitive Impairment
Breast Neoplasms
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The chemotherapy-related cognitive impairment (also called chemobrain) has a great incidence among breast cancer population. However, the knowledge about effective interventions of supportive care is still inconsistent. Furthermore, the majority of programs targeted to this problem has been applied in survivorship, while the onset of cognitive impairment and the decline in quality of life occur during medical treatments. In this line, actual evidence suggests testing the effectiveness of interventions in a preventive setting in patients with breast cancer scheduled to receive neurotoxic chemotherapy. In addition, telehealth approaches have become a promising practice and increasingly more frequent among healthcare disciplines.

Our objective is to study the effects of a videoconferenced cognitive training in combination with cognitive-behavioral strategies to prevent or mitigate the cancer- and chemotherapy-related cognitive impairment in women with breast cancer who undergo this treatment, as well as to improve quality of life and allow an optimal adaptation to the occupational needs derived from medical treatment.

This study will use a two-arm, single blinded randomized clinical trial design. Eligible women will be randomized to one of the following groups: the experimental group that will receive the e-OTCAT program (12 weeks), or the control group that will receive and educational handbook and standard care. The study outcomes will be assessed after intervention and at 6-month follow-up post-randomization.

This study may contribute the need to include disciplines such as occupational therapy in the supportive care of cancer patients during the active phase of the disease, as well as the potential advantages provided by a telehealth approach related to economic, temporal and geographical barriers.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Subjective cognitive Function:
timeFrame: Participants will be followed over 6 months
Secondary outcomes:
measure: Objective Cognitive Function: Attention
timeFrame: Participants will be followed over 6 months
measure: Objective Cognitive Function: Verbal Memory
timeFrame: Participants will be followed over 6 months
measure: Objective Cognitive Function: Working Memory and Processing Speed
timeFrame: Participants will be followed over 6 months
measure: Psychological status
timeFrame: Participants will be followed over 6 months
measure: Cancer-Related Fatigue
timeFrame: Participants will be followed over 6 months.
measure: Quality of Sleep
timeFrame: Participants will be followed over 6 months.
measure: Occupational Performance
timeFrame: Participants will be followed over 6 months
measure: Overall Quality of Life
timeFrame: Participants will be followed over 6 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
References:
citation: 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.