Optimized Rehabilitation Following Primary Breast Cancer Surgery
RE-SCREEN
1 other identifier
interventional
643
1 country
1
Brief Summary
This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients' and relatives' experiences and need of support during the rehabilitation .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2018
CompletedFirst Posted
Study publicly available on registry
February 15, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedDecember 14, 2023
December 1, 2023
7 years
January 15, 2018
December 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Psychological Distress
Psychological Distress measured by the "Distress thermometer". A instrument that the patients answer themselves measuring the level of distress and the potential problems the may have.
Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.
Secondary Outcomes (7)
General Quality of life
Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.
Information needs
Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.
Resilience
Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.
Life style changes
Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.
Health economics
Evaluations will be conducted after data collection is finished. 6 months and one year after inclusion.
- +2 more secondary outcomes
Study Arms (3)
Control (high distress)
EXPERIMENTALControl group receiving care as usual
Individualised rehabilitation
EXPERIMENTALPatients with high distress receive the intervention "individualized rehabilitation" including evaluation of individual needs and based on that physical, psychological or social interventions to promote rehabilitation.
Control group (low distress)
EXPERIMENTALControl group receiving care as usual
Interventions
Patients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer
Patients will get care as usual
Eligibility Criteria
You may qualify if:
- Undergone treatment for primary breast cancer
- ≤18 years old
- Ability to communicate in Swedish
- Written informed consent
You may not qualify if:
- Recurrent disease
- Palliative diagnosis
- Pregnancy
- Prior history of breast cancer
- Inability to participate in the study due to cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (1)
Skåne university hospital
Malmo, Sweden
Related Publications (3)
Olsson IM, Dykes C, Ryden L, Olsson-Moller U, Malmstrom M. Experiences of rehabilitation one year after breast cancer diagnosis-A focus group study from the ReScreen randomized controlled trial. PLoS One. 2025 Feb 13;20(2):e0315814. doi: 10.1371/journal.pone.0315814. eCollection 2025.
PMID: 39946344DERIVEDMalmstrom M, Holst-Hansson A, Olsson Moller U. The complexity of needs and roles of family members during breast cancer rehabilitation: a qualitative study. BMC Cancer. 2024 Nov 21;24(1):1430. doi: 10.1186/s12885-024-13200-x.
PMID: 39567939DERIVEDOlsson Moller U, Ryden L, Malmstrom M. Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial. BMC Cancer. 2020 May 29;20(1):484. doi: 10.1186/s12885-020-06815-3.
PMID: 32471390DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marlene Malmström, PhD
Lund university, department of health siences, Lund
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2018
First Posted
February 15, 2018
Study Start
November 15, 2018
Primary Completion
November 1, 2025
Study Completion
November 1, 2025
Last Updated
December 14, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share