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Breast CancerMyHealthNCT02949167

MyHealth: Follow-up After Breast Cancer Treatment

A study testing MyHealth in people with Breast Cancer, run by Danish Cancer Society at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
MyHealth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
503 participants
Where
1 siteDenmark
Study dates
Nov 2016to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Oncology and Palliative Care, Naestved Hospital

    Næstved, Region Sjælland, 4700

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
MyHealth
Keywords
Nurse-led follow-up after breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MyHealthBehavioural

    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.

Study groups in NCT02949167
Study groupRoleWhat they receive
MyHealth intervention armExperimentalNurse-led follow-up
Receives: Behavioral: MyHealth
MyHealth Control conditionNo interventionPhysician-led follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

Secondary outcomes (8)

  1. 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

    Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

  2. Changes in knowledge, skill, and confidence for self-management

    Patient Activation Measure (PAM)

    Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

  3. Changes in anxiety

    Generalized Anxiety Disorder (GAD-7)

    Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

  4. Changes in self-management

    The Health Education Impact Questionnaire (heiQ)

    Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

  5. Changes in fear of recurrence

    Concerns About Recurrence Questionnaire (CARQ-4)

    Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

  6. Changes in Depression

    The Patient Health Questionnaire (PHQ-9)

    Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

  7. Changes in work ability

    Work Ability Index (WAI)

    Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

  8. Changes in quality-adjusted life year (QALY)

    EuroQol 5 domains (5D), 5 levels (5L)

    Measured: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02949167
Sponsor's protocol ID
Record.12714019
Acronym
MyHealth
Status last verified
Aug 2021
First submitted
25 Oct 2016
Last updated
31 Aug 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Saltbaek L, Bidstrup PE, Karlsen RV, Hoeg BL, Horsboel TA, Belmonte F, Andersen EAW, Zoffmann V, Friberg AS, Svendsen MN, Christensen HG, Glavicic V, Nielsen DL, Dalton SO, Johansen C. Nurse-Led Individualized Follow-Up Versus Regular Physician-Led Visits After Early Breast Cancer (MyHealth): A Phase III Randomized, Controlled Trial. J Clin Oncol. 2024 Jun 10;42(17):2038-2049. doi: 10.1200/JCO.23.01447. Epub 2024 Mar 18.

    PubMed 38498781

Questions about this trial

What is this clinical trial studying?

A study testing MyHealth in people with Breast Cancer, run by Danish Cancer Society at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in breast cancer specific symptom burden (TOI-PFB) (time frame: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02949167, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.

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