REBECCA - Research in Rehabilitation After Breast Cancer
REBECCA
Optimized Rehabilitation: A Randomized Study of Systematic Monitoring and Management of Breast Cancer Patients' Symptoms
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Jul 2013
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 5, 2014
CompletedFirst Posted
Study publicly available on registry
February 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 7, 2015
August 1, 2015
2 years
February 5, 2014
August 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psychological distress
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 Outcomes (7)
Health related quality of life
6 and 12 months
Anxiety and depression
6 and 12 months
Smoking
6 and 12 months
Alcohol consumption
6 and 12 months
Body mass index
6 and 12 months
- +2 more secondary outcomes
Study Arms (2)
Screening-based nurse navigation
EXPERIMENTALBased 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
Usual care
NO INTERVENTIONUsual care
Interventions
Screening-based nurse navigation for breast cancer rehabilitation
Eligibility Criteria
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Danish Cancer Societylead
- TRYG Foundationcollaborator
- Rigshospitalet, Denmarkcollaborator
- Center for Kræft og Sundhedcollaborator
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoffer Johansen, MD, Phd
Danish Cancer Society
- PRINCIPAL INVESTIGATOR
Pernille E Bidstrup, MA. PhD
Danish Cancer Society
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Head, Unit of Survivorship
Study Record Dates
First Submitted
February 5, 2014
First Posted
February 6, 2014
Study Start
July 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 7, 2015
Record last verified: 2015-08