REBECCA

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-07-31

Brief Summary

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The purpose of this study is to examine if a psychosocial intervention including a nurse navigator and systematic symptom screening may reduce psychological and physical symptoms as well as health behavior after breast cancer.

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Detailed Description

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In this pilot study with a randomized controlled trial design, we examine the effect of an intervention optimizing and integrating rehabilitation for breast cancer on psychological and physical symptoms as well as health behavior after breast cancer. In the intervention group, we systematically screen for psychological and physical symptoms as well as health behavior (smoking alcohol and physical activity) not in line with the recommendations. Patients who screen positive are offered a sequence of sessions with a navigator nurse who monitor rehabilitation needs, supports the patient, educate in self-management of symptoms and refer to existing rehabilitation services as well as to up to 6 free sessions with a psychologist specialized in cancer patients. The rehabilitation services that the nurse refers to include several hospital departments and municipality services as well as general practice and by thorough follow-up on the patients use of these, the intervention aims at developing an integrated treatment and rehabilitation trajectory. The control group receives standard care.

Conditions

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Anxiety Depression Adverse Effects Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Screening-based nurse navigation

Based on systematic screening for psychological and physical symptoms as well as health behavior a nurse navigator will refer to and monitor use of appropriate rehabilitation programs

Group Type EXPERIMENTAL

Screening-based nurse navigation

Intervention Type OTHER

Screening-based nurse navigation for breast cancer rehabilitation

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Screening-based nurse navigation

Screening-based nurse navigation for breast cancer rehabilitation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of primary breast cancer at Breast Oncology Clinic, Rigshospitalet, Copenhagen, Denmark
* lives in Copenhagen municipality
* score ≥7 on distress thermometer
* able to read and understand Danish
* not pregnant
* expected survival more than 6 months
* physically able to participate in rehabilitation
* no severe psychiatric disease demanding treatment
* no severe cognitive problems (e.g. dementia or confusion)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No