AnxietyREBECCANCT02056483
REBECCA - Research in Rehabilitation After Breast Cancer
A study testing Screening-based nurse navigation in people with Anxiety and Depression, run by Danish Cancer Society at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Depression, Adverse Effects
- What is being tested?
- Screening-based nurse navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- physically able to participate in rehabilitation
- no severe psychiatric disease demanding treatment
- no severe cognitive problems (e.g. dementia or confusion)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Depression, Adverse Effects, Health Behavior
- Being tested
- Screening-based nurse navigation
- Keywords
- neoplasms, rehabilitation, anxiety, depression, adverse effects, health behavior
- Medical subject headings
- Anxiety Disorders, Depression, Health Behavior, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening-based nurse navigationOther
Screening-based nurse navigation for breast cancer rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Screening-based nurse navigation | Experimental | 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 Receives: Other: Screening-based nurse navigation |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 and 12 months
Secondary outcomes (7)
Health related quality of life
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.
Measured: 6 and 12 months
Anxiety and depression
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).
Measured: 6 and 12 months
Smoking
Difference in change in patient reported cigarette smoking measured in grams per day between patients in intervention and control group.
Measured: 6 and 12 months
Alcohol consumption
Difference in change in patient reported alcohol consumption measured in grams per day between patients in intervention and control group.
Measured: 6 and 12 months
Body mass index
Difference in change in patient reported body masss index between patients in intervention and control group.
Measured: 6 and 12 months
Physical activity
Difference in change in patient reported physical activity between patients in intervention and control group.
Measured: 6 and 12 months
Use of rehabilitation services
Difference in change in patient reported use of rehabilitation services between patients in intervention and control group.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation, Copenhagen University Hospital, Rigshospitalet, Center for Kræft og Sundhed
- Responsible party
- Principal investigator, Christoffer Johansen, Danish Cancer Society
- Investigators
- Christoffer Johansen, MD, Phd, Principal investigator, Danish Cancer SocietyPernille E Bidstrup, MA. PhD, Principal investigator, Danish Cancer Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056483
- Sponsor's protocol ID
- REBECCA
- Acronym
- REBECCA
- Status last verified
- Aug 2015
- First submitted
- 5 Feb 2014
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Rehabilitation: A Randomized Study of Systematic Monitoring and Management of Breast Cancer Patients' Symptoms
- ClinicalTrials.gov ID
- NCT02056483
- Acronym / sponsor ID
- REBECCA / REBECCA
- Conditions
- Anxiety, Depression, Adverse Effects, Health Behavior
- Keywords
- neoplasms, rehabilitation, anxiety, depression, adverse effects, health behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- TRYG Foundation, Copenhagen University Hospital, Rigshospitalet, Center for Kræft og Sundhed
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening-based nurse navigation | Experimental | Other: Screening-based nurse navigationBased 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 intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening-based nurse navigationScreening-based nurse navigation for breast cancer rehabilitation | Other | Screening-based nurse navigation |
Primary outcome
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
7 secondary outcomes
Health related quality of life
Time frame: 6 and 12 months
Anxiety and depression
Time frame: 6 and 12 months
Smoking
Time frame: 6 and 12 months
Alcohol consumption
Time frame: 6 and 12 months
Body mass index
Time frame: 6 and 12 months
Physical activity
Time frame: 6 and 12 months
Use of rehabilitation services
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoffer Johansen, MD, Phd principal investigator
Danish Cancer Society
Pernille E Bidstrup, MA. PhD principal investigator
Danish Cancer Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening-based nurse navigation in people with Anxiety and Depression, run by Danish Cancer Society at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.