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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Copenhagen University Hospital at Herlev | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Individually tailored nurse navigation |
|
| Control | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individually tailored nurse navigation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Distress | Distress Thermometer | Change from baseline and to 6,12 months (mixed models) |
| Measure | Description | Time Frame |
|---|---|---|
| Distress | Distress Thermometer | Change from baseline to 6 months |
| Distress | Distress Thermometer | Change from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Social support | Modified Medical Outcomes Study Social Support Scale (MOS) | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pernille Bidstrup, PhD | Danish Cancer Society Research Center | Principal Investigator |
| Christoffer Johansen, DMSc | Rigshispitalet | Principal Investigator |
| Birgitte Mertz, RN | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | DK-2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37351885 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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Intervention status will be blinded in analyses.
| Distress | Distress Thermometer | Change from baseline to 18 months |
| Depression | The Patient Health Questionnaire (PHQ9) | Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) |
| Depression | The Patient Health Questionnaire (PHQ9) | Change from baseline and to 6 months |
| Depression | The Patient Health Questionnaire (PHQ9) | Change from baseline and to 12 months |
| Depression | The Patient Health Questionnaire (PHQ9) | Change from baseline and to 18 months |
| Anxiety | Generalized Anxiety Disorder (GAD7) | Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models) |
| Anxiety | Generalized Anxiety Disorder (GAD7) | Change from baseline and to 6 months |
| Anxiety | Generalized Anxiety Disorder (GAD7) | Change from baseline and to 12 months |
| Anxiety | Generalized Anxiety Disorder (GAD7) | 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:
| 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:
| 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:
| 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:
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Change from baseline and to 18 months |
| Self-efficacy | Patient Activation Measure (PAM) | Change from baseline and to 6,12,18 months (mixed models) |
| Self-efficacy | Patient Activation Measure (PAM) | Change from baseline and to 6 months |
| Self-efficacy | Patient Activation Measure (PAM) | Change from baseline and to 12 months |
| Self-efficacy | Patient Activation Measure (PAM) | Change from baseline and to 18 months |
| Fear of recurrence | Concerns About Recurrence Questionnaire (CARQ) | 6 months |
| Fear of recurrence | Concerns About Recurrence Questionnaire (CARQ) | 12 months |
| Fear of recurrence | Concerns About Recurrence Questionnaire (CARQ) | 18 months |
| Pain in the breast surgery area (side of chest, armpit or arm) | Self-developed scale | 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 | Change from baseline and to 6 months |
| Pain in the breast surgery area (side of chest, armpit or arm) | Self-developed scale | Change from baseline and to 12 months |
| Pain in the breast surgery area (side of chest, armpit or arm) | Self-developed scale | Change from baseline and to 18 months |
| Neuropathy in the breast surgery area (side of chest, armpit or arm) | Self-developed scale | 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 | Change from baseline and to 6 months |
| Neuropathy in the breast surgery area (side of chest, armpit or arm) | Self-developed scale | Change from baseline and to 12 months |
| Neuropathy in the breast surgery area (side of chest, armpit or arm) | Self-developed scale | Change from baseline and to 18 months |
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) | Change from baseline and to 6,12,18 months (mixed models) |
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) | Change from baseline and to 6 months |
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) | Change from baseline and to 12 months |
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Change from baseline and to 18 months |
| Need for support | Single self-developed items | Change from baseline and to 6,12,18 months (mixed models) |
| Need for support | Single self-developed items | Change from baseline and to 6 months |
| Need for support | Single self-developed items | Change from baseline and to 12 months |
| Need for support | Single self-developed items | 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 | Cumulative from baseline to 18 months |
| Acceptability | Single self-developed items | 18 months |
| D017437 |
| Skin and Connective Tissue Diseases |