Optimized Rehabilitation Following Primary Breast Cancer Surgery (RE-SCREEN)

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms; Rehabilitation; Psychological Distress
• Intervention / Treatment: Other: Care as usual; Other: Individualised rehabilitation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 643
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ulrika Olsson Möller, PhD; Phone Number: +46705896983; Email: ulrika.olsson_moller@hkr.se
• Study Contact Backup: Name: Marlene Malmström, Ass professor; Phone Number: +4646175950; Email: marlene.malmstrom@med.lu.se

Study Locations

• Sweden
  • Malmö, Sweden
    • Recruiting
    • Skåne University Hospital
    • Contact: Marlene Malmström, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control (high distress); Control group receiving care as usual	Other: Care as usual; Patients will get care as usual
Experimental: Individualised rehabilitation; Patients 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.	Other: Individualised rehabilitation; Patients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer
Experimental: Control group (low distress); Control group receiving care as usual	Other: Care as usual; Patients will get care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Lund University
• Investigators: Principal Investigator: Marlene Malmström, PhD, Lund university, department of health siences, Lund

Publications and helpful links

General Publications

• Olsson 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: RESCREEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No