An interventional study of Individually tailored nurse navigation in Breast Cancer, sponsored by Danish Cancer Society. Completed at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-27.
Sponsored by Danish Cancer Society · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
Individually tailored nurse navigation
Behavioral: Individually tailored nurse navigation
Usual care
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.
Distress
Distress Thermometer
Time frame: Change from baseline and to 6,12 months (mixed models)
Distress
Distress Thermometer
Time frame: Change from baseline to 6 months
Distress
Distress Thermometer
Time frame: Change from baseline to 12 months
Distress
Distress Thermometer
Time frame: Change from baseline to 18 months
Depression
The Patient Health Questionnaire (PHQ9)
Time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Depression
The Patient Health Questionnaire (PHQ9)
Time frame: Change from baseline and to 6 months
Depression
The Patient Health Questionnaire (PHQ9)
Time frame: Change from baseline and to 12 months
Depression
The Patient Health Questionnaire (PHQ9)
Time frame: Change from baseline and to 18 months
Anxiety
Generalized Anxiety Disorder (GAD7)
Time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Anxiety
Generalized Anxiety Disorder (GAD7)
Time frame: Change from baseline and to 6 months
Anxiety
Generalized Anxiety Disorder (GAD7)
Time frame: Change from baseline and to 12 months
Anxiety
Generalized Anxiety Disorder (GAD7)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from baseline and to 18 months
Self-efficacy
Patient Activation Measure (PAM)
Time frame: Change from baseline and to 6,12,18 months (mixed models)
Self-efficacy
Patient Activation Measure (PAM)
Time frame: Change from baseline and to 6 months
Self-efficacy
Patient Activation Measure (PAM)
Time frame: Change from baseline and to 12 months
Self-efficacy
Patient Activation Measure (PAM)
Time frame: Change from baseline and to 18 months
Fear of recurrence
Concerns About Recurrence Questionnaire (CARQ)
Time frame: 6 months
Fear of recurrence
Concerns About Recurrence Questionnaire (CARQ)
Time frame: 12 months
Fear of recurrence
Concerns About Recurrence Questionnaire (CARQ)
Time frame: 18 months
Pain in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Time frame: 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
Time frame: Change from baseline and to 6 months
Pain in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Time frame: Change from baseline and to 12 months
Pain in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Time frame: Change from baseline and to 18 months
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Time frame: 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
Time frame: Change from baseline and to 6 months
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Time frame: Change from baseline and to 12 months
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Self-developed scale
Time frame: Change from baseline and to 18 months
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline and to 6,12,18 months (mixed models)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline and to 6 months
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline and to 12 months
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline and to 18 months
Need for support
Single self-developed items
Time frame: Change from baseline and to 6,12,18 months (mixed models)
Need for support
Single self-developed items
Time frame: Change from baseline and to 6 months
Need for support
Single self-developed items
Time frame: Change from baseline and to 12 months
Need for support
Single self-developed items
Time frame: 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
Time frame: Cumulative from baseline to 18 months
Acceptability
Single self-developed items
Time frame: 18 months
Social support
Modified Medical Outcomes Study Social Support Scale (MOS)
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Danish Cancer Society