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Breast NeoplasmsNCT04783402

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

A study testing e-OTCAT program in people with Breast Neoplasms, run by Universidad de Granada at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
e-OTCAT program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteSpain
Study dates
31 Oct 2020to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Spain1 site

  • University of Granada

    Granada, 18016

Other trials in Spain

About this study

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.

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.

Read the 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.

Being tested
e-OTCAT program, Educational handbook and standard care
Keywords
Chemotherapy, Occupational Therapy, Quality of Life, Cognitive Impairment, Breast Neoplasms
Medical subject headings
Breast Neoplasms, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-OTCAT programOther

    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.

  • Educational handbook and standard careOther

    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.

Study groups in NCT04783402
Study groupRoleWhat they receive
e-OTCATExperimentalThe 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.
Receives: Other: e-OTCAT program
Control GroupOtherAt 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.
Receives: Other: Educational handbook and standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Participants will be followed over 6 months

Secondary outcomes (8)

  1. Objective Cognitive Function: Attention

    The Trail Making Test (A and B parts) will be used to assess speed for attention, sequencing, mental flexibility, visual search and motion function. Time spent in each part is noted. Lower results (less time) indicate better test performance.

    Measured: Participants will be followed over 6 months

  2. Objective Cognitive Function: Verbal Memory

    The Rey Auditory Verbal Learning Test will be used to assess verbal memory and learning. A greater number of remembered words indicate better performance.

    Measured: Participants will be followed over 6 months

  3. Objective Cognitive Function: Working Memory and Processing Speed

    Wechsler Adult Intelligence Scale (WAIS-IV) will be used to assess working memory and processing speed. We will use the following tests: digit span, arithmetic, symbol search and coding. Higher scores in each test indicate a better cognitive performance.

    Measured: Participants will be followed over 6 months

  4. Psychological status

    The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression. In the HADS subscales (anxiety and depression), scores ranging from 0 to 21. Scores between 8-10 indicate suspicious case of anxiety or depression, and scores higher than 11 are likely cases of anxiety or depression.

    Measured: Participants will be followed over 6 months

  5. Cancer-Related Fatigue

    The Piper Fatigue Scale-Revised (PFS-R) will be used to assess the presence of cancer-related fatigue. Items are grouped into four dimensions (behavioral, cognitive, sensorial and affective) obtaining a global score. Higher results indicate a higher level of fatigue.

    Measured: Participants will be followed over 6 months.

  6. Quality of Sleep

    The Pittsburgh Sleep Quality Index (PSQI) will be used to assess the quality of sleep through the following dimensions: quality, latency, duration, efficiency, alterations, use of medication and daily dysfunction. A total score is obtained ranging from 0 to 21. Higher scores indicate a poor quality of sleep.

    Measured: Participants will be followed over 6 months.

  7. Occupational Performance

    The Canadian Occupational Performance Measure (COPM) will be used to assess the self-perception of performance and satisfaction with activities of daily living.

    Measured: Participants will be followed over 6 months

  8. Overall Quality of Life

    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3.0 will be used to assess quality of life. The EORTC QLQ-C30 is composed of five functional scales (role, physical, cognitive, emotional and social), a global quality of life scale and nine symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact). Higher scores in the first two subscales indicate better function and quality of life, while higher scores in the symptom scales indicate a major impact of those symptoms.

    Measured: Participants will be followed over 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start31 Oct 2020
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04783402
Sponsor's protocol ID
e-OTCAT20
Status last verified
Dec 2023
First submitted
21 Feb 2021
Last updated
11 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35742400

Questions about this trial

What is this clinical trial studying?

A study testing e-OTCAT program in people with Breast Neoplasms, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective cognitive Function: (time frame: Participants will be followed over 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04783402, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.

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