Clinical trial NCT02949167: MyHealth: Follow-up After Breast Cancer Treatment
Official title: MyHealth: Nurse-led Compared to Physician-led Breast Cancer Follow-up: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Nurse-led follow-up after breast cancer
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: Region Sjælland
First posted: 2016-10-31
Enrollment: 503
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Complete remission following primary treatment for loco-regional BC (stage I-II) - No confirmed genetic predisposition to BC
* Female gender
* Performance status ≤3
* Read, understand and speak Danish
* No severe cognitive problems
* No severe psychiatric disease requiring treatment or any substance abuse.

Exclusion Criteria:

* Genetic predisposition for BC
* Patient younger than 40 years of age at diagnosis
* Control after recurrent breast cancer
* Other active cancer except non-melanoma skin cancer
* Severe cognitive problems or dementia
* Severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence

Primary outcomes:
measure: Changes in breast cancer specific symptom burden (TOI-PFB)
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Secondary outcomes:
measure: Changes in breast cancer specific symptom burden
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in knowledge, skill, and confidence for self-management
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in anxiety
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in self-management
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in fear of recurrence
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in Depression
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in work ability
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
measure: Changes in quality-adjusted life year (QALY)
timeFrame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Other outcomes:
measure: Health Care Use
timeFrame: at 60 months
Locations:
city: Naestved
country: Denmark
facility: Department of Oncology and Palliative Care, Naestved Hospital
state: Region Zealand
Study officials:
affiliation: The Cancer Society Research Center, Survivorship
name: Christoffer Johansen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Department for Oncology Naestved and Roskilde Hospital
name: Mads N Svendsen, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: