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

NCT06120595 | Active Not Recruiting

• 3 other identifiers: REBECCA2SUHREBECCA-SUH-Inter-QoL965231
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Quality of life (QoL) measured by the SF36-questionnaire.

  The SF-36 scores the patients physical and mental health on a scale of 0-100, where higher values indicate better health. An increase of 10% or more indicates an improved QoL.

  Every 6 months, from time of diagnosis to 24-months.

Secondary Outcomes (15)

• Fatigue in primary breast cancer patients measured by the fVAS questionnaire.

  Every 6 months, from time of diagnosis to 24-months.

• Fatigue in primary breast cancer patients measured by the FSS questionnaire.

  Every 6 months, from time of diagnosis to 24-months.

• Fatigue in primary breast cancer patients measured by the FQ questionnaire.

  Every 6 months, from time of diagnosis to 24-months.

• Effect on fatigue levels after personalized training with a physiotherapist.

  Every 6 months, from time of diagnosis to 18-months.

• Fatigue biomarker HSP90 in plasma of primary breast cancer patients.

  Every 6 months, from time of diagnosis to 24-months.

Study Arms (2)

Standard of care

OTHER

Patients will receive standard follow-up according to national guidelines developed by the Norwegian Breast cancer group (NBCG).

Other: Standard follow-up

Standard of care + REBECCA-assisted intervention

EXPERIMENTAL

Patients will, in addition to receiving standard follow-up every 6 months, also receive REBECCA-assisted follow-up at frequencies when the REBECCA-system indicate this. The patients will receive a REBECCA smartwatch that they will wear for 12 months. They will also have to install a REBECCA patient app on their mobile and a REBECCA plug-in on their computer for objective RWD collection related to their QoL and lifestyle over the next 12 months. 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) who will create a personalized training programme, e.g. 2-4 sessions per week.

Drug: REBECCA-assisted intervention 1; Behavioral: REBECCA-assisted intervention 2; Other: Standard follow-up

Interventions

REBECCA-assisted intervention 1 DRUG

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

Standard of care + REBECCA-assisted intervention

REBECCA-assisted intervention 2 BEHAVIORAL

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

Standard of care + REBECCA-assisted intervention

Standard follow-up OTHER

Standard follow-up

Standard of care; Standard of care + REBECCA-assisted intervention

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants have had histologically proven M0 breast cancer (stage 0-II) breast cancer that require neoadjuvant or adjuvant chemo- and/or radio-therapy at least and no more than 3 months pre-study initiation.
• Age between 19 and 80 years
• Have increased life expectancy beyond the initial 3 months post-treatment.
• Have the ability to understand protocol, participate in testing and willingness to sign a written informed consent.
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

You may not qualify if:

• Male breast cancer patients
• Patients that are not willing to sign an informed consent form
• A previous cancer diagnosis (excluding skin cancers treated by surgery only)
• Patients previously treated by any form of chemo/radiotherapy.

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, Rogaland, 4067, Norway

Location

Study Officials

• Svein Skeie, PhD

  Helse Stavanger HF

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: May 1, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-03

Locations

NO (1)