Breast CancerREBECCA IINCT03254875
Rehabilitation After Breast Cancer
A study testing Individually tailored nurse navigation in people with Breast Cancer, run by Danish Cancer Society at 1 site in Denmark.
Trial summary
The aim of the study is to evaluate whether a screening-based individually tailored nurse navigator intervention compared to standard care significantly reduce psychological and physical symptoms among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Individually tailored nurse navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2017to 31 Mar 2021
- 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
- Newly diagnosed with breast cancer (i.e. prior to surgery), scheduled for breast cancer surgery at Section of Breast Surgery at Rigshospitalet, 18 years or above, Danish citizen, read, understand and speak Danish, female gender,signed written informed consent. Those who experience high psychological distress (score ≥ 7 on the distress thermometer) will enter the RCT whereas those who experience low psychological distress (score < 7 on the distress thermometer) will be followed in an observational questionnaire study.
Who cannot join
- no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individually Tailored Rehabilitation After Breast Cancer
The aim of the study is to evaluate whether a screening-based individually tailored nurse navigator intervention compared to standard care significantly reduce psychological and physical symptoms among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer).
Read the detailed description
During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter the randomized controlled trial (RCT) and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.
- Conditions
- Breast Cancer
- Being tested
- Individually tailored nurse navigation
- Keywords
- Breast cancer, Psychosocial intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually tailored nurse navigationBehavioural
The intervention consists of systematic report of symptoms to the nurse and up to six individual, manual-based, face-to-face or telephone nurse navigator sessions depending on individual needs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Individually tailored nurse navigation Receives: Behavioral: Individually tailored nurse navigation |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress
Distress Thermometer
Measured: Change from baseline and to 6,12 months (mixed models)
Secondary outcomes (72)
Distress
Distress Thermometer
Measured: Change from baseline to 6 months
Distress
Distress Thermometer
Measured: Change from baseline to 12 months
Distress
Distress Thermometer
Measured: Change from baseline to 18 months
Depression
The Patient Health Questionnaire (PHQ9)
Measured: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Depression
The Patient Health Questionnaire (PHQ9)
Measured: Change from baseline and to 6 months
Depression
The Patient Health Questionnaire (PHQ9)
Measured: Change from baseline and to 12 months
Depression
The Patient Health Questionnaire (PHQ9)
Measured: Change from baseline and to 18 months
Anxiety
Generalized Anxiety Disorder (GAD7)
Measured: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Anxiety
Generalized Anxiety Disorder (GAD7)
Measured: Change from baseline and to 6 months
Anxiety
Generalized Anxiety Disorder (GAD7)
Measured: Change from baseline and to 12 months
Anxiety
Generalized Anxiety Disorder (GAD7)
Measured: Change from baseline and to 18 months
Health related quality of life summary index
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
- Physical well-being (PWB)
- Functional wellbeing (FWB)
- BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Health related quality of life summary index
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
- Physical well-being (PWB)
- Functional wellbeing (FWB)
- BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 6 months
Health related quality of life summary index
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
- Physical well-being (PWB)
- Functional wellbeing (FWB)
- BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 12 months
Health related quality of life summary index
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
- Physical well-being (PWB)
- Functional wellbeing (FWB)
- BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 18 months
Breast cancer related quality of life summary index
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Breast cancer related quality of life summary index
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 6 months
Breast cancer related quality of life summary index
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 12 months
Breast cancer related quality of life summary index
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 18 months
Functional related quality of life summary index
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Functional related quality of life summary index
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 6 months
Functional related quality of life summary index
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 12 months
Functional related quality of life summary index
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 18 months
Physical health related quality of life
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Physical health related quality of life
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 6 months
Physical health related quality of life
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 12 months
Physical health related quality of life
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 18 months
Social health related quality of life
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Social health related quality of life
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 6 months
Social health related quality of life
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 12 months
Social health related quality of life
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 18 months
Emotional health related quality of life
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Emotional health related quality of life
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 6 months
Emotional health related quality of life
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 12 months
Emotional health related quality of life
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Measured: Change from baseline and to 18 months
Self-efficacy
Patient Activation Measure (PAM)
Measured: Change from baseline and to 6,12,18 months (mixed models)
Self-efficacy
Patient Activation Measure (PAM)
Measured: Change from baseline and to 6 months
Self-efficacy
Patient Activation Measure (PAM)
Measured: Change from baseline and to 12 months
Self-efficacy
Patient Activation Measure (PAM)
Measured: Change from baseline and to 18 months
Fear of recurrence
Concerns About Recurrence Questionnaire (CARQ)
Measured: 6 months
Fear of recurrence
Concerns About Recurrence Questionnaire (CARQ)
Measured: 12 months
Fear of recurrence
Concerns About Recurrence Questionnaire (CARQ)
Measured: 18 months
Pain in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Measured: Change from baseline and to 6,12,18 months (mixed models)
Pain in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Measured: Change from baseline and to 6 months
Pain in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Measured: Change from baseline and to 12 months
Pain in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Measured: Change from baseline and to 18 months
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Measured: Change from baseline and to 6,12,18 months (mixed models)
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Measured: Change from baseline and to 6 months
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Measured: Change from baseline and to 12 months
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Measured: Change from baseline and to 18 months
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: Change from baseline and to 6,12,18 months (mixed models)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: Change from baseline and to 6 months
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: Change from baseline and to 12 months
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: Change from baseline and to 18 months
Cognitive function - Perceived cognitive impairments
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Measured: Change from baseline and to 6,12,18 months (mixed models)
Cognitive function - Perceived cognitive impairments
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Measured: Change from baseline and to 6 months
Cognitive function- Perceived cognitive impairments
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Measured: Change from baseline and to 12 months
Cognitive function - Perceived cognitive impairments
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Measured: Change from baseline and to 18 months
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
Measured: Change from baseline and to 6,12,18 months (mixed models)
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
Measured: Change from baseline and to 6 months
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
Measured: Change from baseline and to 12 months
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
Measured: Change from baseline and to 18 months
Cognitive function - Perceived cognitive abilities
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Measured: Change from baseline and to 6,12,18 months (mixed models)
Cognitive function - Perceived cognitive abilities
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Measured: Change from baseline and to 6 months
Cognitive function - Perceived cognitive abilities
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Measured: Change from baseline and to 12 months
Cognitive function - Perceived cognitive abilities
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Measured: Change from baseline and to 18 months
Need for support
Single self-developed items
Measured: Change from baseline and to 6,12,18 months (mixed models)
Need for support
Single self-developed items
Measured: Change from baseline and to 6 months
Need for support
Single self-developed items
Measured: Change from baseline and to 12 months
Need for support
Single self-developed items
Measured: Change from baseline and to 18 months
Health care costs
Costs will be obtained through registries on health care services and combined with information on health status using the 5Q-5D from the EuroQol Research Foundation's
Measured: Cumulative from baseline to 18 months
Acceptability
Single self-developed items
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start15 Aug 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Model description
- During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter the RCT and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Copenhagen University Hospital at Herlev
- Responsible party
- Principal investigator, Christoffer Johansen, Danish Cancer Society
- Investigators
- Pernille Bidstrup, PhD, Principal investigator, Danish Cancer Society Research CenterChristoffer Johansen, DMSc, Principal investigator, RigshispitaletBirgitte Mertz, RN, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254875
- Sponsor's protocol ID
- REBECCA II
- Acronym
- REBECCA II
- Status last verified
- Aug 2021
- First submitted
- 31 Jul 2017
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591.
PubMed 37351885
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Tailored Rehabilitation After Breast Cancer
- ClinicalTrials.gov ID
- NCT03254875
- Acronym / sponsor ID
- REBECCA II / REBECCA II
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Copenhagen University Hospital at Herlev
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 21 Aug 2017 (actual)
- 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 aim of the study is to evaluate whether a screening-based individually tailored nurse navigator intervention compared to standard care significantly reduce psychological and physical symptoms among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer).
Detailed description
During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter the randomized controlled trial (RCT) and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter the RCT and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Individually tailored nurse navigationIndividually tailored nurse navigation |
| Control | 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 (1 listed)
- Newly diagnosed with breast cancer (i.e. prior to surgery), scheduled for breast cancer surgery at Section of Breast Surgery at Rigshospitalet, 18 years or above, Danish citizen, read, understand and speak Danish, female gender,signed written informed consent. Those who experience high psychological distress (score ≥ 7 on the distress thermometer) will enter the RCT whereas those who experience low psychological distress (score < 7 on the distress thermometer) will be followed in an observational questionnaire study.
Key exclusion criteria (1 listed)
- no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,
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 |
|---|---|---|
| Individually tailored nurse navigationThe intervention consists of systematic report of symptoms to the nurse and up to six individual, manual-based, face-to-face or telephone nurse navigator sessions depending on individual needs. | Behavioural | Intervention |
Primary outcome
Distress
Time frame: Change from baseline and to 6,12 months (mixed models)
Distress Thermometer
72 secondary outcomes
Distress
Time frame: Change from baseline to 6 months
Distress
Time frame: Change from baseline to 12 months
Distress
Time frame: Change from baseline to 18 months
Depression
Time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Depression
Time frame: Change from baseline and to 6 months
Depression
Time frame: Change from baseline and to 12 months
Depression
Time frame: Change from baseline and to 18 months
Anxiety
Time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Anxiety
Time frame: Change from baseline and to 6 months
Anxiety
Time frame: Change from baseline and to 12 months
Anxiety
Time frame: Change from baseline and to 18 months
Health related quality of life summary index
Time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Health related quality of life summary index
Time frame: Change from baseline and to 6 months
Health related quality of life summary index
Time frame: Change from baseline and to 12 months
Health related quality of life summary index
Time frame: Change from baseline and to 18 months
Breast cancer related quality of life summary index
Time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Breast cancer related quality of life summary index
Time frame: Change from baseline and to 6 months
Breast cancer related quality of life summary index
Time frame: Change from baseline and to 12 months
Breast cancer related quality of life summary index
Time frame: Change from baseline and to 18 months
Functional related quality of life summary index
Time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Functional related quality of life summary index
Time frame: Change from baseline and to 6 months
Functional related quality of life summary index
Time frame: Change from baseline and to 12 months
Functional related quality of life summary index
Time frame: Change from baseline and to 18 months
Physical health related quality of life
Time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Physical health related quality of life
Time frame: Change from baseline and to 6 months
Physical health related quality of life
Time frame: Change from baseline and to 12 months
Physical health related quality of life
Time frame: Change from baseline and to 18 months
Social health related quality of life
Time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Social health related quality of life
Time frame: Change from baseline and to 6 months
Social health related quality of life
Time frame: Change from baseline and to 12 months
Social health related quality of life
Time frame: Change from baseline and to 18 months
Emotional health related quality of life
Time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Emotional health related quality of life
Time frame: Change from baseline and to 6 months
Emotional health related quality of life
Time frame: Change from baseline and to 12 months
Emotional health related quality of life
Time frame: Change from baseline and to 18 months
Self-efficacy
Time frame: Change from baseline and to 6,12,18 months (mixed models)
Self-efficacy
Time frame: Change from baseline and to 6 months
Self-efficacy
Time frame: Change from baseline and to 12 months
Self-efficacy
Time frame: Change from baseline and to 18 months
Fear of recurrence
Time frame: 6 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 27 Aug 2021.
- Derived from this study: PubMed 37351885Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591.
- Individual participant dataSharing planned: No
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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.
Pernille Bidstrup, PhD principal investigator
Danish Cancer Society Research Center
Christoffer Johansen, DMSc principal investigator
Rigshispitalet
Birgitte Mertz, RN study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individually tailored nurse navigation in people with Breast Cancer, 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 1 inclusion and 1 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 27 Aug 2021. 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?
Distress (time frame: Change from baseline and to 6,12 months (mixed models)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03254875, which also lists 1 linked publication.
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 27 Aug 2021.