REBECCA - Research in Rehabilitation After Breast Cancer (REBECCA)

August 5, 2015 updated by: Christoffer Johansen, Danish Cancer Society

Optimized Rehabilitation: A Randomized Study of Systematic Monitoring and Management of Breast Cancer Patients' Symptoms

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: 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
Other: Screening-based nurse navigation
Screening-based nurse navigation for breast cancer rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological distress
Time Frame: 6 and 12 months
Difference in change in psychological distress between patients in the intervention and control group.Psychological distress wil be measured using the Distress Thermometer
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life
Time Frame: 6 and 12 months
Difference in change in patient reported health related quality of life between patients in the intervention and control group. Health related quality of life will be measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC QLQ C30 and the EORTC BR23 including subscales.
6 and 12 months
Anxiety and depression
Time Frame: 6 and 12 months
Difference in change in patient reported anxiety and depression between patients in the intervention and control group. Anxiety and depresison will be measured using the Hospital Anxiety and Depression scale (HADS).
6 and 12 months
Smoking
Time Frame: 6 and 12 months
Difference in change in patient reported cigarette smoking measured in grams per day between patients in intervention and control group.
6 and 12 months
Alcohol consumption
Time Frame: 6 and 12 months
Difference in change in patient reported alcohol consumption measured in grams per day between patients in intervention and control group.
6 and 12 months
Body mass index
Time Frame: 6 and 12 months
Difference in change in patient reported body masss index between patients in intervention and control group.
6 and 12 months
Physical activity
Time Frame: 6 and 12 months
Difference in change in patient reported physical activity between patients in intervention and control group.
6 and 12 months
Use of rehabilitation services
Time Frame: 6 and 12 months
Difference in change in patient reported use of rehabilitation services between patients in intervention and control group.
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Cancer Society

Collaborators

Rigshospitalet, Denmark
TRYG Foundation
Center for Kræft og Sundhed

Investigators

  • Principal Investigator: Christoffer Johansen, MD, Phd, Danish Cancer Society
  • Principal Investigator: Pernille E Bidstrup, MA. PhD, Danish Cancer Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 5, 2014

First Posted (Estimate)

February 6, 2014

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rebecca

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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