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.
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.
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].”
Saltbæk L, Karlsen RV, Bidstrup 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