Rehabilitation After Breast Cancer

Study Overview
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Brief Summary
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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).

Detailed Description
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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 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.

Official Title
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Individually Tailored Rehabilitation After Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Individually tailored nurse navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Individually tailored nurse navigation | Behavioral: Individually tailored nurse navigation<br>* 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.<br>|
| No Intervention: Control<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress | Distress Thermometer | Change from baseline and to 6,12 months (mixed models) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress | Distress Thermometer | Change from baseline to 6 months | 
| Distress | Distress Thermometer | Change from baseline to 12 months | 
| 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: Physical well-being (PWB) Functional wellbeing (FWB) 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) | 
| 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Psychosocial intervention