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

Lund University

Status: Enrolling

Conditions: Rehabilitation; Breast Neoplasms; Psychological Distress

Treatments: Other: Care as usual; Other: Individualised rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03434717

RESCREEN

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 643 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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643 participants in 3 patient groups

Control (high distress)

Experimental group

Description:

Control group receiving care as usual

Treatment:

Other: Care as usual

Individualised rehabilitation

Experimental group

Description:

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.

Treatment:

Other: Individualised rehabilitation

Control group (low distress)

Experimental group

Description:

Control group receiving care as usual

Treatment:

Other: Care as usual