Telehealth Program to Prevent Cancer and Chemotherapy-related Cognitive Impairment.

University of Granada (UGR)

Status: Invitation-only

Conditions: Breast Neoplasms

Treatments: Other: Educational handbook and standard care; Other: e-OTCAT program

Study type: Interventional

Funder types: Other

Identifiers

NCT04783402

e-OTCAT20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

e-OTCAT

Experimental group

Description:

The 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.

Treatment:

Other: e-OTCAT program

Control Group

Other group

Description:

At 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.

Treatment:

Other: Educational handbook and standard care