MyHealth: Follow-up After Breast Cancer Treatment (MyHealth)

August 30, 2021 updated by: Christoffer Johansen, Danish Cancer Society

MyHealth: Nurse-led Compared to Physician-led Breast Cancer Follow-up: A Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

503

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Zealand
      • Naestved, Region Zealand, Denmark, 4700
        • Department of Oncology and Palliative Care, Naestved Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MyHealth intervention arm
Nurse-led follow-up
Behavioral: MyHealth
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
Physician-led follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
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)
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in anxiety
Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Generalized Anxiety Disorder (GAD-7)
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
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)
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
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)
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in Depression
Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
The Patient Health Questionnaire (PHQ-9)
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Changes in work ability
Time Frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Work Ability Index (WAI)
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
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)
at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Care Use
Time Frame: at 60 months
Study specific items on health care use single items
at 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Cancer Society

Collaborators

Region Sjælland

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 28, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Record.12714019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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