MyHealth: Follow-up After Breast Cancer Treatment

NCT02949167 | Unknown

• 1 other identifier: Record.12714019
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Nurse-led follow-up after breast cancer

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (8)

• Changes in breast cancer specific symptom burden

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

• Changes in knowledge, skill, and confidence for self-management

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

• Changes in anxiety

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

• Changes in self-management

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

• Changes in fear of recurrence

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

Other Outcomes (1)

• Health Care Use

  at 60 months

Study Arms (2)

MyHealth intervention arm

EXPERIMENTAL

Nurse-led follow-up

Behavioral: MyHealth

MyHealth Control condition

NO INTERVENTION

Physician-led follow-up

Interventions

MyHealth BEHAVIORAL

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.

MyHealth intervention arm

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Cancer Society: lead
• Region Sjælland: collaborator

Study Sites (1)

Department of Oncology and Palliative Care, Naestved Hospital

Næstved, Region Sjælland, 4700, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38498781 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christoffer Johansen, Professor

  The Cancer Society Research Center, Survivorship

  PRINCIPAL INVESTIGATOR

• Mads N Svendsen, MD, PHD

  The Department for Oncology Naestved and Roskilde Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 31, 2016
• Study Start: November 1, 2016
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

DK (1)