Clinical trial · Observational
Monitoring of Chronic Conditions in Breast Cancer
REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Fatigue Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Mild Cancer Related Fatigue
- description
- After treatment(6 months from inclusion) is ended a fVAS \< 50
- label
- Cancer related Fatigue
- description
- After treatment (6 months from inclusion) with fVAS ≥ 50 mm or a rise of fVAS of ≥ 25 mm.
- label
- Healthy control
- description
- Healthy women matches with age 1. 50-70: women attending the mammography screening 2. 19-50: invitation in newspaper, flyers and posters
Primary outcomes (4)
- measure
- Level of fatigue at diagnosis - baseline
- timeFrame
- This will be done at diagnosis, before treatment.
- description
- Visual Analogue Scale (fVAS), which is a score from 0 to 100 mm marked on a 100 mm line on a paper.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer patients with histologically detectable M0 breast cancer (stage 0-III) who require neoadjuvant or adjuvant endocrine, chemo and / or radiation therapy at least and no more than 3 months before initiation of study. * Female breast cancer patients between 19 and 80 years of age. * Patients who have increased their life expectancy beyond the first 3 months after starting treatment. * Patients who have the ability to understand the protocol and can participate in the follow-up plan. * Patients who have an absence of psychological, familial, sociological or geographical condition that potentially impedes compliance with the study protocol and follow-up plan. Exclusion criteria: * Male breast cancer patients. * Patients who do not agree to the study protocol. * Patients with a previous cancer diagnosis (excluding skin cancer treated only by surgery). * Patients who have previously been treated with some form of chemotherapy / radiation therapy.
References
Publications (15)
- BACKGROUNDKhozin S, Blumenthal GM, Pazdur R. Real-world Data for Clinical Evidence Generation in Oncology. J Natl Cancer Inst. 2017 Nov 1;109(11). doi: 10.1093/jnci/djx187. PMID 29059439
- BACKGROUNDEichler HG, Pignatti F, Schwarzer-Daum B, Hidalgo-Simon A, Eichler I, Arlett P, Humphreys A, Vamvakas S, Brun N, Rasi G. Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth. Clin Pharmacol Ther. 2021 May;109(5):1212-1218. doi: 10.1002/cpt.2083. Epub 2020 Nov 12. PMID 33063841
- BACKGROUNDHjermstad MJ, Fayers PM, Bjordal K, Kaasa S. 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). J Clin Oncol. 1998 Mar;16(3):1188-96. doi: 10.1200/JCO.1998.16.3.1188. PMID 9508207
- BACKGROUNDChalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147-53. doi: 10.1016/0022-3999(93)90081-p. PMID 8463991
- BACKGROUNDLoge JH, Kaasa S. Short form 36 (SF-36) health survey: normative data from the general Norwegian population. Scand J Soc Med. 1998 Dec;26(4):250-8. PMID 9868748
- BACKGROUNDBardsen K, Nilsen MM, Kvaloy JT, Norheim KB, Jonsson G, Omdal R. Heat shock proteins and chronic fatigue in primary Sjogren's syndrome. Innate Immun. 2016 Apr;22(3):162-7. doi: 10.1177/1753425916633236. Epub 2016 Feb 25. PMID 26921255
- BACKGROUNDSmith AK, Conneely KN, Pace TW, Mister D, Felger JC, Kilaru V, Akel MJ, Vertino PM, Miller AH, Torres MA. Epigenetic changes associated with inflammation in breast cancer patients treated with chemotherapy. Brain Behav Immun. 2014 May;38:227-36. doi: 10.1016/j.bbi.2014.02.010. Epub 2014 Feb 28.