NCT06120595

Intervention Study Based on Real-world Data to Improve Quality of Life After Breast Cancer Treatment, the REBECCA-2 Study

Status unknown NA Last updated 27 June 2024

What this trial tests

NA trial testing REBECCA-assisted intervention 1 in Cancer Related Fatigue in 81 participants. Status unknown.

Timeline

1 November 2022

Primary endpoint
1 November 2023

1 May 2025

Quick facts

Lead sponsor	Helse Stavanger HF
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	81
Start date	1 November 2022
Primary completion	1 November 2023
Estimated completion	1 May 2025
Sites	1 location across Norway

Drugs / interventions tested

• REBECCA-assisted intervention 1 — full drug profile →
• REBECCA-assisted intervention 2
• Standard follow-up

Conditions studied

• Cancer Related Fatigue — all drugs for Cancer Related Fatigue →

Sponsor

Helse Stavanger HF — full company profile →

Who can join

Adults 19 to 80, female only, with Cancer Related Fatigue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overall objective of the REBECCA studies at Stavanger University Hospital (SUH) is to improve the QoL of patients affected by cancer-related fatigue during and after end of treatment, by collecting multi-source real world data (RWD) and intervening based on the collected RWD.

In the intervention study, REBECCA-2, the investigators will use the collected real world data to provide a personalised follow-up to the breast cancer patients in order to improve their quality of life. The patients in this study are randomised into 2 groups after end of primary treatment:

* The control group (n=55): Patients will receive standard follow-up according to national guidelines plus 3 generic lifestyle consultation sessions via telephone.
* The experimental REBECCA group (n=55): Patients will, in addition to receiving standard follow-up also receive REBECCA-assisted follow-up. Data will be collected from a REBECCA smartwatch, plug-in and PROMs.

If the REBECCA system detects signs of deterioration in patients' QoL during the study period, the intervention will include changes in medication given, dietary advice, referral to a psychologist/psychiatrist and/or personal training with a physiotherapist at 'Pusterommet' (SUH)

After 12 months of RWD collection participants will be offered the option to continue in the study for another 6 months. For patients in the experimental Rebecca group this includes the use of the REBECCA system for another 6 months. In the clinical REBECCA-2 study, patients' visits are planned every 6 months and include collection of both PROMs and biological samples.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Monitoring cancer-related fatigue and quality of life in breast and prostate cancer patients after primary treatment: a study protocol for the REBECCA trials in Norway.
   Stensland M, Bru KF, Austdal M, Dahl IH, et al · · 2026 · PMID 41655181 · DOI 10.1007/s10238-026-02073-y