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
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Among 226 studies in Breast Neoplasms with a site in Denmark — 29 open to participants now, 57 under way, 22 of them phase 3. Breast Neoplasms · Denmark.
Among the 226 studies in Breast Neoplasms with a site in Denmark, this one is the 77th largest by enrollment of the 193 interventional ones that give a count, is one of 13 that started in 2017, is one of 55 with no phase, and was the 135th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →29 of the 226 studies in Breast Neoplasms with a site in Denmark are open now. Recruiting first, the newest first:
UMC Utrecht · Sites in Denmark, Germany, Netherlands and 1 more country
Ages 35+
Novartis Pharmaceuticals · Sites in Denmark, United States, Canada and 8 more countries
Ages 18+
Novartis Pharmaceuticals · Sites in Denmark, United States, Canada and 4 more countries
Ages 18+
Vejle Hospital · Sites in Denmark
Ages 18+
Relay Therapeutics, Inc. · Sites in Denmark, United States, Argentina and 24 more countries
Ages 18+
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
226 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 36 · Phase 2 54 · Phase 3 58 · Phase 4 7
First in 1990; this study’s year is marked. 13 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 309 is above the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 210 across the 193 interventional studies, 200 across the 31 observational. Of the 147 that completed or were terminated, 52 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
98 of 226 have an industry lead sponsor. The 10 most frequent:
Danish Cancer Society is the lead sponsor of 22 studies on the registry; none are open to participants now.
Danish Cancer Society has 7 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
17 of the studies in Breast Neoplasms with a site in Denmark that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05038735Phase 3Novartis PharmaceuticalsStudy to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. | 2027-01-28 |
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
| NCT04421963Phase 3AstraZenecaRoll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib | 2027-04-06 |
| NCT04784715Phase 3AstraZenecaTrastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | 2027-05-03 |
| NCT06312176Phase 3Merck Sharp & Dohme LLCA Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) | 2027-07-11 |
Add all 17 to your calendar (.ics) → With an account.
Among the 226 studies in Breast Neoplasms with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Ran from Aug 2017 to primary completion in Mar 2021, 43 months.
Of 2,662 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 43 months is above that.
Counting every sponsor, half of 2,772 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Danish Cancer Society