MyHealth: Follow-up After Breast Cancer Treatment (MyHealth)
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|ClinicalTrials.gov Identifier: NCT02949167|
Recruitment Status : Active, not recruiting
First Posted : October 31, 2016
Last Update Posted : February 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: MyHealth||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||501 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||MyHealth: Nurse-led Compared to Physician-led Breast Cancer Follow-up: A Randomized Controlled Trial|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 31, 2024|
Experimental: MyHealth intervention arm
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.
No Intervention: MyHealth Control condition
- Changes in breast cancer specific symptom burden (TOI-PFB) [ Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months ]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
- Changes in breast cancer specific symptom burden [ Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months ]Functional Assessment of Cancer Therapy -Breast (FACT-B) Domains: Physical well-being, social/family well-being, Emotional well-being,Functional wellbeing, BC symptoms
- Changes in knowledge, skill, and confidence for self-management [ Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months ]Patient Activation Measure (PAM)
- Changes in anxiety [ Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months ]Generalized Anxiety Disorder (GAD-7)
- Changes in self-management [ Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months ]The Health Education Impact Questionnaire (heiQ)
- Changes in fear of recurrence [ Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months ]Concerns About Recurrence Questionnaire (CARQ-4)
- Changes in Depression [ Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months ]The Patient Health Questionnaire (PHQ-9)
- Changes in work ability [ Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months ]Work Ability Index (WAI)
- Changes in quality-adjusted life year (QALY) [ Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months ]EuroQol 5 domains (5D), 5 levels (5L)
- Health Care Use [ Time Frame: at 60 months ]Study specific items on health care use single items
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949167
|Department of Oncology and Palliative Care, Naestved Hospital|
|Naestved, Region Zealand, Denmark, 4700|
|Principal Investigator:||Christoffer Johansen, Professor||The Cancer Society Research Center, Survivorship|
|Principal Investigator:||Mads N Svendsen, MD, PHD||The Department for Oncology Naestved and Roskilde Hospital|