An ongoing Danish randomized, controlled trial is evaluating physical and psychological outcomes in women treated for early-stage breast cancer receiving routine oncologist-led follow-up in outpatient clinics vs a nurse-led program using the Guided Self-Determination Method (GSD), patient-reported outcomes (PROs), and patient navigation. An early report of study feasibility was published in Acta Oncologica.  

The importance of follow-up for women treated for early-stage breast cancer, including the development of self-management skills, has been widely recognized. In this study, replacement of the more traditional paradigm of physician-led follow-up with nurse-led self-management interventions is being evaluated. Study end points included evaluation of physical and psychological symptoms, as well as breast cancer-specific health-related quality of life (HRQOL), and time to detection of disease recurrence,

“To the best of our knowledge, this has never been undertaken before,” the authors said.


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Eligibility criteria for the study included completion of primary treatment for stage I/II breast cancer without evidence of disease recurrence, Eastern Cooperative Oncology Group (ECOG) performance status of 3 or lower; women with breast cancer diagnosed at age younger than 40 or those with a hereditary predisposition for breast cancer were excluded. 

The MyHealth intervention program consisted of 3 to 5 individual appointments with a nurse specialist within the first 6 months of follow-up based on the GSD, collection of PROs every 3 months for the first year and every 6 months during the following 2 years, and nurse-led patient support in symptom management and navigation. The control arm involved in-clinic appointments with an oncologist every 6 months for 3 years. Questionnaires evaluating patient demographic information, as well as assessments of HRQOL were completed at regular intervals by patients in both study arms.

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An early evaluation of study feasibility showed participation by 25 patients, representing 78% of those recruited. A high rate of PRO completion was also observed.

The authors noted that “the strength of the feasibility study is the high recruitment and adherence rate proving the reorganization of follow-up possible and the elements in the intervention acceptable and relevant for [patients with breast cancer].” 

Reference

Saltbæk LKarlsen RVBidstrup PE, et al. MyHealth: specialist nurse-led follow-up in breast cancer. A randomized controlled trial — development and feasibility [published online January 30, 2019]. doi: 10.1080/0284186X.2018.1563717