Optimized Rehabilitation Following Primary Breast Cancer Surgery

Breast Neoplasms Clinical Trial

— RE-SCREEN  

Official title:

Optimized Rehabilitation Following Primary Breast Cancer Surgery - Systematic Screening as a Tool for Individualised Rehabilitation: Study Protocol for the RE-SCREEN Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03434717
• Other study ID #: RESCREEN
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: November 2025

Study information

• Verified date: December 2023
• Source: Lund University
• Contact: Marlene Malmström, Ass professor
• Phone: +4646175950
• Email: marlene.malmstrom[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Description:

Breast cancer survivors are known to suffer from remaining problems from their treatment after surgery. Despite numerous of studies evaluating the effect of various rehabilitation programs it is know that patients often receive rehabilitation recommendations that are general rather than individualised to their needs. The large amount of studies within this area have contributed to knowledge about potential beneficial rehabilitation interventions for these patients but there is still a lack of knowledge about how patients specific needs of rehabilitation can be identified and how health care can adjust and individualize rehabilitation to optimize rehabilitation. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 643
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergone treatment for primary breast cancer

• =18 years old

• Ability to communicate in Swedish

• Written informed consent

Exclusion Criteria:

• Recurrent disease

• Palliative diagnosis

• Pregnancy

• Prior history of breast cancer

• Inability to participate in the study due to cognitive impairment

Related Conditions & MeSH terms

• Breast Neoplasms
• Psychological Distress
• Rehabilitation

Intervention

Other:
• Individualised rehabilitation
Patients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer
• Care as usual
Patients will get care as usual

Locations

Country	Name	City	State
Sweden	Skåne university hospital	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	General Quality of life	The instrument QLQ-C30 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measurers 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.
Secondary	Information needs	The INFO35 instrument is developed by the EORTC and measures the patients perception of information received	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	Resilience	Conner-Davidsson Resilience scale (CD-RISC) will be used to measure patients resilience trough 25 questions ranging from 0-4. Lower scores indicates more problems	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	Life style changes	Life style changes will be measured by single items concerning exercise (amount hours of physical activity/day), Body mass index (based on weight and length), alcohol (units/glasses/ day) and tobacco habits (yes/no)	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	Health economics	Cost-effectiveness analysis will be performed by evaluations of health care consumption (number of and total cost of health care visits) and by evaluating sickness absence (number of days)	Evaluations will be conducted after data collection is finished. 6 months and one year after inclusion.
Secondary	Breast cancer specific quality of life	The instrument QLQ-BR23 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measurers diagnose specific 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.
Secondary	Satisfaction with care	Singel items focusing on satisfaction with care	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.