REBECCA - Recearch in Rehabilitation After Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Danish Cancer Society
Sponsor:
Collaborators:
TRYG Foundation
Rigshospitalet, Denmark
Center for Kræft og Sundhed
Information provided by (Responsible Party):
Christoffer Johansen, Danish Cancer Society
ClinicalTrials.gov Identifier:
NCT02056483
First received: February 5, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Anxiety
Depression
Adverse Effects
Health Behavior
Other: Screening-based nurse navigation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Optimized Rehabilitation: A Randomized Study of Systematic Monitorering and Management of Breast Cancer Patients' Symptoms

Resource links provided by NLM:


Further study details as provided by Danish Cancer Society:

Primary Outcome Measures:
  • Psychological distress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Difference in change in psychological distress between patients in the intervention and control group.Psychological distress wil be measured using the Distress Thermometer


Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Anixiety and depression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).

  • Smoking [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Difference in change in patient reported cigarette smoking measured in grams per day between patients in intervention and control group.

  • Alcohol consumption [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Difference in change in patient reported alcohol consumption measured in grams per day between patients in intervention and control group.

  • Body mass index [ Time Frame: 6 motnhs ] [ Designated as safety issue: No ]
    Difference in change in patient reported body masss index between patients in intervention and control group.

  • Physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Difference in change in patient reported physical activity between patients in intervention and control group.

  • Use of rehabilitation services [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Difference in change in patient reported use of rehabilitation services between patients in intervention and control group.


Estimated Enrollment: 108
Study Start Date: July 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Screening-based nurse navigation
Based on systematic screening for psyhological and physical symptoms as well as health behavior a nurse navigator will refer to and momnitor use of appropriate rehabilitation programs
Other: Screening-based nurse navigation
Screening-based nurse navigation for breast cancer rehabilitation
No Intervention: Usual care
Usual care

Detailed Description:

In this pilot study with a randsomized 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056483

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Niels Kroman, MD, Phd       Niels.kroman@rh.regionh.dk   
Contact: Birgitte Mertz, MNursSc       Birgitte.Goldschmidt.Mertz@regionh.dk   
Sub-Investigator: Niels Kroman, MD, Phd         
Sub-Investigator: Birgitte Mertz, MNursSc         
Sponsors and Collaborators
Danish Cancer Society
TRYG Foundation
Rigshospitalet, Denmark
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
  More Information

No publications provided

Responsible Party: Christoffer Johansen, Professor, Head, Unit of Survivorship, Danish Cancer Society
ClinicalTrials.gov Identifier: NCT02056483     History of Changes
Other Study ID Numbers: REBECCA
Study First Received: February 5, 2014
Last Updated: February 5, 2014
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by Danish Cancer Society:
neoplasms
rehabilitation
anxiety
depression
adverse effects
health behavior

Additional relevant MeSH terms:
Anxiety Disorders
Breast Neoplasms
Depression
Depressive Disorder
Mental Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on August 19, 2014