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NCT Number: NCT05277935

Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib

Combining a fitness tracker technology with real-time patient-reported outcome monitoring associated with interventions through a health care app is a novel strategy to evaluate metastatic breast cancer patients using Palbociclib and endocrine treatment.

Recruiting

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Key information

Conditions

Breast Neoplasm Female Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oncoclínicas, Rio de Janeiro, Brazil

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About this study

Measure the quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and EuroQol -5D - European quality of life in five dimensions and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients ≥ 18 years of age diagnosed with hormone receptor-positive/ human epidermal growth factor receptor 2- negative metastatic breast cancer undergoing treatment with Palbociclib combined with aromatase inhibitors (letrozole, exemestane or anastrozole) or fulvestrant as first-line therapy, or in treatment with Palbociclib and fulvestrant as second-line or posterior-line therapy in the metastatic setting; may be using ovarian suppression if the patient is premenopausal.
  • The patient must be on treatment for at least three (3) months with Palbociclib and endocrine therapy.
  • Evidence of a signed and dated informed consent document, physically or digitally, indicating that the research participant was informed about all relevant aspects of the study;
  • The patient agrees not to participate in another study with drug intervention while on treatment.
  • Have performance status according to the Eastern Cooperative Oncology Group
  • Have access to a compatible smartphone and 3G or 4G internet connection

Exclusion criteria

  • Patients considered to be at poor medical risk due to uncontrolled serious medical disorder, non-malignant systemic disease, or active uncontrolled infection. Examples: uncontrolled ventricular arrhythmia, recent myocardial infarction (within 6 months), stroke, gastrointestinal bleeding, or any psychiatric disorder that precludes informed consent; between others.
  • Patients who have a life expectancy of < 3 months.
  • Treatment with any product under investigation during the last 28 days;
  • Another acute or chronic medical or psychiatric condition or severe laboratory abnormality that could increase the risk associated with participation in the study or that Page 10 de 21 Version 6.0 could interfere with the interpretation of the study results and, in the investigator's judgment, would make the research participant unsuitable for inclusion in the study. study.
  • Illiterate patients or those with a low level of education that may prevent the correct use of the Wecancer application and/or the watch with monitoring of physical activity.

Treatment and study plan

Use of the WeCancer app combined with the smartwatch.

Device

To evaluate if a fitness tracker added to eHealth technology will improve quality of life compared to the use of eHealth technology alone in metastasis breast cancer patients treated with palbociclib and endocrine therapy

Primary outcomes

  1. Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast

    Time frame: Baseline

    Measure the Quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.

    The comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.

  2. Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast

    Time frame: Follow up 2 month

    Measure the Quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.

    The comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.

  3. Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast

    Time frame: Follow up 4 month

    Measure the Quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.

    The comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.

  4. Assess quality of life through the quality-of-life questionnaire through the Functional Assessment of Cancer Therapy - Breast

    Time frame: Follow up 6 month

    Measure the Quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.

    The comparison of the two groups in relation to quality of life, measured by the general score of the Functional Assessment of Cancer Therapy - Breast and its sub-items, over time will be made using a linear model withmixed effects, that is, fixed effects and random effects. Time and group fixed effects will be considered, the patient will be considered random effect. The effects of time, group and interaction between them will be tested.

Study contacts

Contact information is provided by the study sponsor or research team.

Bianca Verboski

CONTACT

[email protected]

11-35052639 ext. 55

Bianca Verboski

CONTACT

[email protected]

11-35052639 ext. 55

Sponsors and collaborators

Lead sponsor

Beneficência Portuguesa de São Paulo

Other

Registry information

Acronym: WEFITTER

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2022
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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