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Optimized Rehabilitation Following Primary Breast Cancer Surgery

NCT ID: NCT03434717

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

643 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2025-11-30

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Rehabilitation Breast Neoplasms Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control (high distress)

Control group receiving care as usual

Group Type EXPERIMENTAL

Care as usual

Intervention Type OTHER

Patients will get care as usual

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.

Group Type EXPERIMENTAL

Individualised rehabilitation

Intervention Type OTHER

Patients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer

Control group (low distress)

Control group receiving care as usual

Group Type EXPERIMENTAL

Care as usual

Intervention Type OTHER

Patients will get care as usual

Interventions

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Individualised rehabilitation

Patients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer

Intervention Type OTHER

Care as usual

Patients will get care as usual

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marlene Malmström, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund university, department of health siences, Lund

Locations

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Skåne university hospital

Malmo, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Marlene Malmström, Ass professor

Role: CONTACT

Phone: +4646175950

Email: [email protected]

Ulrika Olsson Möller, PhD

Role: CONTACT

Phone: +46705896983

Email: [email protected]

Facility Contacts

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Marlene Malmström, PHD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39946344 (View on PubMed)

Malmstrom 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.

Reference Type DERIVED
PMID: 39567939 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32471390 (View on PubMed)

Other Identifiers

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RESCREEN

Identifier Type: -

Identifier Source: org_study_id