An interventional study of MyHealth in Breast Cancer, sponsored by Danish Cancer Society. Status unknown at 1 site in Denmark. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-08-31.
Sponsored by Danish Cancer Society · Not applicable, Interventional, and Treatment
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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 58th largest by enrollment of the 193 interventional ones that give a count, is one of 12 that started in 2016, is one of 55 with no phase, and was the 124th 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: 40 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. 12 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 503 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:
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Approximately 24,000 women attend a follow-up care program after end of primary treatment for breast cancer (BC) in Denmark. There is no well-conducted, larger randomized controlled trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of recurrence, good management of symptoms and cost-effectiveness. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored symptom management program (MyHealth) will significantly reduce reported symptoms among BC patients following primary treatment compared to physician-led scheduled follow-up. Secondary, the investigators will examine patient activation (self-management), anxiety, depression, fear of recurrence, work ability, time to recurrence, overall survival, health behavior changes, health care utilization and financial costs in the two arms.
The MyHealth program provides patients with a nurse-led education focusing on management of symptoms, an electronic platform to report symptoms to the nurses and support in symptom management and navigation of patients to appropriate health care services.
During an 18-month period, 494 primary BC patients will be recruited from the Departments of Oncology at Naestved and Roskilde Hospital. The women will be enrolled in the study following completion of primary treatment. Participants are randomized 1:1 to the intervention (Nurse-led follow up) or control group (physician-led follow-up) and followed for 5 years. No matter group assignment, all women will follow the national mammography screening programs.
Patients who accept to participate are asked to invite a close relative, preferably partners, to participate in the study. Patients, who do not want to participate in the randomization will be asked if they are willing to participate in the study by filling out two questionnaires. Patients who decline to participate in the MyHealth study will be enrolled in the standard follow-up.
The investigators will collect data using questionnaires, clinical databases, and national registers before intervention and for 5 years after inclusion both in the control and intervention arm. Questionnaires from validated scales are used to measure primary and secondary outcomes in both groups whereas Patient Reported Outcomes (PRO) are only collected in the intervention group. Patients who experiences relapse during the MyHealth intervention will not be asked to fill in the remaining outcome questionnaires or PROs since they quit the follow-up program in favor of treatment for recurrent disease.
During follow-up, the patient will consult the nurse or the project physician if PROs reveal a need, or if the patient require a consultation. In order to ensure that treatment of symptoms and referral to other health professionals will meet clinical guidelines the nurses are instructed to follow a detailed response algorithm, which is developed by the project physician in collaboration with experienced oncologists.
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Exclusion Criteria:
Nurse-led follow-up
Behavioral: MyHealth
Physician-led follow-up
The MyHealth intervention is a nurse-led individually tailored symptom management program, focused on patient education and regularly collection of Patient Reported Outcomes (PRO) subsequently evaluated by specialist nurses and navigation to health care service. The nurse will meet with the patient on three-five planned appointments focused on adjustment of life after breast cancer treatment including information on symptoms of relapse or late effects and how to react on these. Close relatives are invited if patients accept. Patients will report PRO´s on symptoms of recurrence and late effects every three months during the first year and thereafter every six months.The appointments with the nurse are finalized within 3-6 month and patients will be followed with PRO for three years.
Changes in breast cancer specific symptom burden (TOI-PFB)
Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score of the Functional Assessment of Cancer Therapy -Breast (FACT-B) Domains: Physical well-being, Functional wellbeing,BC symptoms
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in breast cancer specific symptom burden
Functional Assessment of Cancer Therapy -Breast (FACT-B) Domains: Physical well-being, social/family well-being, Emotional well-being,Functional wellbeing, BC symptoms
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in knowledge, skill, and confidence for self-management
Patient Activation Measure (PAM)
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in anxiety
Generalized Anxiety Disorder (GAD-7)
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in self-management
The Health Education Impact Questionnaire (heiQ)
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in fear of recurrence
Concerns About Recurrence Questionnaire (CARQ-4)
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in Depression
The Patient Health Questionnaire (PHQ-9)
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in work ability
Work Ability Index (WAI)
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in quality-adjusted life year (QALY)
EuroQol 5 domains (5D), 5 levels (5L)
Time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Health Care Use
Study specific items on health care use single items
Time frame: at 60 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2016 (actual). Primary completion is estimated for Apr 2024, 89 months after the start.
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 planned 89 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 status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Danish Cancer Society