Actively Recruiting

Age: 19Years - 80Years
FEMALE
Healthy Volunteers
ID05587777

REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data Monitoring of Chronic Conditions in Breast Cancer Survivors

Led by Helse Stavanger HF · Updated on 2022-10-20

150

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating fatigue in breast cancer survivors through an observational study called REBECCA-1. This study focuses on using real-world data collected via electronic patient records, digital registers, smartphones, and wearable devices to better understand cancer-related fatigue (CRF). CRF is a common, persistent side effect after breast cancer treatment, affecting physical, mental, and emotional well-being. The study also explores immunological biomarkers that may be linked to fatigue development. Participants include breast cancer patients who have completed treatment and healthy women as controls. Breast cancer patients are grouped based on fatigue severity, measured by a fatigue visual analogue scale (fVAS). Participants will use a REBECCA smartwatch, smartphone app, and PC plug-in to collect objective data on activity, sleep, and social behavior over 12 months. Biological samples and patient-reported outcome measures (PROMs) will be collected at diagnosis and at multiple follow-up points up to 18 months. During the study, participants will complete questionnaires about quality of life, lifestyle, and symptoms, while their biological samples will be analyzed for biomarkers related to fatigue. Data from smart devices will track physical activity and movement patterns daily. Researchers will compare subjective reports, objective monitoring, and biomarker data to gain insights into fatigue's impact. The study aims to improve understanding of fatigue in breast cancer survivors and enhance patient monitoring using innovative digital tools over an 18-month period.

CONDITIONS

Brief Title

Monitoring of Chronic Conditions in Breast Cancer

Who Can Participate

Age: 19Years - 80Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female breast cancer patients aged 19 to 80 years
  • Histologically confirmed stage 0-III breast cancer
  • Scheduled for neoadjuvant or adjuvant endocrine, chemotherapy, and/or radiation therapy starting within 3 months before study
  • Life expectancy extended beyond 3 months after starting treatment
  • Ability to understand the study protocol and participate in follow-up
  • No psychological, familial, social, or geographical barriers that prevent compliance with the study
Not Eligible

You will not qualify if you...

  • Male breast cancer patients
  • Patients who do not agree to the study protocol
  • Patients with prior cancer diagnosis except skin cancer treated only by surgery
  • Patients previously treated with chemotherapy or radiation therapy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At diagnosis (baseline)

Participants undergo initial assessments including patient-reported outcome measures and collection of biological samples at diagnosis before treatment begins.

1 visit (in-person)

Observation after Treatment and Group Assignment

Duration - At 6 months after diagnosis and treatment

After completing cancer treatment, participants are assessed for fatigue levels and assigned to either the Cancer Related Fatigue arm, Mild Cancer Related Fatigue arm, or healthy control group.

1 visit (in-person)

Long-term Monitoring

Duration - 12 months (from month 6 to month 18 after diagnosis)

Participants wear a smartwatch and use mobile and computer apps to continuously collect real-world data related to quality of life, activity, and symptoms over 12 months. Patient-reported outcome measures and biological samples are collected at 6, 12, and 18 months after diagnosis.

Visits at 6, 12, and 18 months post-diagnosis with continuous data collection via devices

Trial Site Locations

Total: 1 location

1

Helse Stavanger HF

Stavanger, Norway, 4068

Actively Recruiting

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Research Team

T

Tone Hoel Lende, PhD

H

Håvard Søiland, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Health-related quality of life in the general Norwegian population assessed by the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire: the QLQ=C30 (+ 3).

M J Hjermstad, P M Fayers, K Bjordal...

https://pubmed.ncbi.nlm.nih.gov/9508207