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

NCT06120595 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2024-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Cancer Related Fatigue

Interventions

DRUG

REBECCA-assisted intervention 1

The intervention will include changes in medication (e.g. change from Letrozol to Tamoxifen, treatment for polyneuropathy, osteoporosis).

BEHAVIORAL

REBECCA-assisted intervention 2

The intervention will include dietary advice, to a psychologist/psychiatrist and/or personal training with a physiotherapist at 'Pusterommet' (SUH).

OTHER

Standard follow-up

Standard follow-up

Sponsors & Collaborators

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Svein Skeie, PhD · Helse Stavanger HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-11-01
Completion
2025-05-01

Countries

  • Norway

Study Locations

More Related Trials

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 NCT06120595 on ClinicalTrials.gov