Pernille Christiansen Skovlund1,2,3, Henriette Vind Thaysen3,4, Henrik Schmidt2, Jan Alsner1, Niels Henrik Hjollund5,6,7, Kirsten Lomborg3,6,8, Berit Kjærside Nielsen3,9. 1. Experimental Clinical Oncology, Department of Oncology, Aarhus University Hospital, Aarhus N, Denmark. 2. Department of Oncology, Aarhus University Hospital, Aarhus N, Denmark. 3. The Research Centre for Patient Involvement, Aarhus University & the Central Denmark Region, Aarhus N, Denmark. 4. Department of Surgery, Aarhus University Hospital, Aarhus N, Denmark. 5. AmbuFlex - Center for Patient-reported Outcomes, Hospital Unit West Jutland, Herning, Denmark. 6. Faculty of Health, Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark. 7. Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus N, Denmark. 8. Steno Diabetes Center Copenhagen, Gentofte, Denmark. 9. DEFACTUM, Social & Health Services and Labour Market, Central Denmark Region, Aarhus N, Denmark.
Abstract
BACKGROUND: With increased survival among patients with metastatic melanoma and limited time with health care providers, patients are expected to assume a more active role in managing their treatment and care. Activated patients have the knowledge, skills, and confidence to make effective solutions to self-manage health. The use of patient-reported outcomes (PRO) could have the potential to enhance patient activation. However, PRO-based interventions that facilitate an activation in patients with metastatic melanoma are lacking and warranted. MATERIAL AND METHODS: In this prospective non-randomized controlled, clinical trial, patients with metastatic melanoma were assigned to either the intervention (systematic feedback and discussion of PRO during consultation) given at one hospital or the control group (treatment as usual) if they received treatment from two other hospitals in Denmark. The primary outcome was the patient activation measure (PAM), which reflects self-management. Secondary outcomes were health-related quality of life (HRQoL), self-efficacy, and Patient-Physician interaction. Outcomes were measured at baseline, and after 3, 6, and 12 months. The analysis of the effect from baseline to 12 months employed mixed-effects modeling. RESULTS: Between 2017 and 2019, patients were allocated to either the intervention group (n = 137) or the control group (n = 142). We found no significant difference in the course of patient activation between the two groups over time. The course of HRQoL was statistically significantly improved by the intervention compared to the control group. Especially, females in the intervention group performed better than males. The other secondary outcomes were not improved by the intervention. CONCLUSION: The intervention did not improve knowledge, skills, and confidence for self-management for patients with metastatic melanoma. Neither did it improve coping self-efficacy nor perceived efficacy in Patient-Physician interaction. However, the results suggest that the intervention can have a significant impact on HRQoL and in particular social and emotional well-being among the females.
BACKGROUND: With increased survival among patients with metastatic melanoma and limited time with health care providers, patients are expected to assume a more active role in managing their treatment and care. Activated patients have the knowledge, skills, and confidence to make effective solutions to self-manage health. The use of patient-reported outcomes (PRO) could have the potential to enhance patient activation. However, PRO-based interventions that facilitate an activation in patients with metastatic melanoma are lacking and warranted. MATERIAL AND METHODS: In this prospective non-randomized controlled, clinical trial, patients with metastatic melanoma were assigned to either the intervention (systematic feedback and discussion of PRO during consultation) given at one hospital or the control group (treatment as usual) if they received treatment from two other hospitals in Denmark. The primary outcome was the patient activation measure (PAM), which reflects self-management. Secondary outcomes were health-related quality of life (HRQoL), self-efficacy, and Patient-Physician interaction. Outcomes were measured at baseline, and after 3, 6, and 12 months. The analysis of the effect from baseline to 12 months employed mixed-effects modeling. RESULTS: Between 2017 and 2019, patients were allocated to either the intervention group (n = 137) or the control group (n = 142). We found no significant difference in the course of patient activation between the two groups over time. The course of HRQoL was statistically significantly improved by the intervention compared to the control group. Especially, females in the intervention group performed better than males. The other secondary outcomes were not improved by the intervention. CONCLUSION: The intervention did not improve knowledge, skills, and confidence for self-management for patients with metastatic melanoma. Neither did it improve coping self-efficacy nor perceived efficacy in Patient-Physician interaction. However, the results suggest that the intervention can have a significant impact on HRQoL and in particular social and emotional well-being among the females.