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Monitoring of Chronic Conditions in Breast Cancer

NCT05587777 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-10-20

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Svein Skeie, PhD · Helse Stavanger HF

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2024-06-15
Completion
2028-06-15

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05587777 on ClinicalTrials.gov