MyHealth: Follow-up After Breast Cancer Treatment

Overview

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.

Full Title of Study: “MyHealth: Nurse-led Compared to Physician-led Breast Cancer Follow-up: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2024

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: MyHealth intervention arm
    • Nurse-led follow-up
  • No Intervention: MyHealth Control condition
    • Physician-led follow-up

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Danish Cancer Society
  • Collaborator
    • Region Sjælland
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christoffer Johansen, Professor – Danish Cancer Society
  • Overall Official(s)
    • Christoffer Johansen, Professor, Principal Investigator, The Cancer Society Research Center, Survivorship
    • Mads N Svendsen, MD, PHD, Principal Investigator, The Department for Oncology Naestved and Roskilde Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.