Actively Recruiting

Age: 19Years - 80Years
FEMALE
Healthy Volunteers
NCT05587777

Monitoring of Chronic Conditions in Breast Cancer

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

150

Participants Needed

1

Research Sites

313 weeks

Total Duration

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AI-Summary

What this Trial Is About

REBECCA-1 is an observational study. Clinical research is undergoing a revolutionary change. The use of electronic patient records (EHR), digital registers, smartphones etc will create "real-world data" (RWD) that provides great opportunities for advancing clinical research, but so far this opportunity has been little exploited. The REBECCA -1 study will observe and monitor fatigue in breast cancer survivors. Investigators will use self reported questionnaires (PROM-data), blood tests and objective regulations like the REBECCCA -1 smart watch that will register amount of steps every day, leaving the house, visiting friends, cafes etc. There will be three observational arms; 1.high fatigue, 2. low fatigue and 3. a healthy control arm. After the patients have finished their treatment, they will receive the REBECCA smart watch, a REBECCA app on the smart phone and a REBECCA plus device on their computer, The next offend are also invited to report their evaluation through the same apps. The observational time will be 1 year and comparison between the subjective PROM data , the objective REBECCA watch and the biological samples will be obtained.

CONDITIONS

Official 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 breast cancer stage 0 to III with no distant metastasis
  • Patients starting neoadjuvant or adjuvant endocrine, chemotherapy, and/or radiation therapy within 3 months before study start
  • Expected to live beyond the first 3 months after treatment begins
  • Ability to understand the study protocol and participate in follow-up
  • No psychological, family, social, or geographical barriers that would prevent study compliance and follow-up
Not Eligible

You will not qualify if you...

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

AI-Screening

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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

CONTACT

H

Håvard Søiland, PhD

CONTACT

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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Monitoring of Chronic Conditions in Breast Cancer | DecenTrialz