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To Live Better After Breast Cancer Treatment

NCT06471452 · Karolinska Institutet
In plain English

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Official title
To Live Better After Breast Cancer Treatment - a Randomized Pilot Trial of a Supportive and Person-centered Care Intervention in Primary Healthcare
About this study
The incidence rate of breast cancer has increased during the past decades and has surpassed lung cancer as the most frequently diagnosed type of cancer worldwide. In Sweden, it is the most common cancer among women and in 2021, 8 616 women received a diagnosis, the ten-year survival rate is over 87%. The overall increase in survival rates can be explained by population-based mammography screening, early detection, and advancements in treatment. The negative impact of treatment on patients' quality of life (QoL) has been established as important to consider in the adjuvant treatment setting of operable breast cancer. Furthermore, several treatments are given over longer periods; e.g. anti-hormonal treatments are prescribed for up to 10 years after a breast cancer diagnosis. As the number of patients with breast cancer increases, so does the demands on the healthcare services throughout the whole cancer trajectory. Patient-reported outcome (PRO) is an outcome that is reported by the patients. Previous research on collecting PRO:s through an interactive application during treatment for breast cancer, pancreatic cancer, and prostate cancer shows promising results such as reduced symptom burden and improved QoL as well as survival. Current research emphasizes the importance of user involvement in the development phase of web-based interventions and that its content is specific to the patient´s needs as well as delivered at the right stage in the cancer trajectory. The aim is to pilot- test routine assessment of patient's reported symptoms and support in self-management assisted by digital technology for six months during the first year after primary treatment for breast cancer in combination with health dialogues with a study-specific nurse at the Primary healthcare centre. The primary objective is to evaluate the acceptability and feasibility of a digital and nurse-led support intervention in primary healthcare for patients with breast cancer during the first year after primary treatment. The secondary objectives of this trial are to (i) evaluate the potential efficacy of the intervention, (ii) obtain estimates for secondary outcome measures and potential mediators and moderators to be used in a future trial and (iii) evaluate the feasibility of such assessments. There are 250 PHCCs within the region and to achieve representativeness for randomization the Care Need Index (CNI) for calculating economic compensation to the PHCC is used. It measures healthcare needs for the distribution of primary care resources to the population with the biggest need. A high CNI index equals low socioeconomic status, and a low CNI index equals high socioeconomic status. The intervention involves the entire PHCC and cluster randomisation is used to avoid a spill-over effect. Approximately ten PHCCs will be matched on CNI index and the number of patients allocated to the PHCCs.
Eligibility criteria
Inclusion Criteria: * patients with breast cancer at the end of curative treatment * able to read and understand Swedish * considered being physically, psychologically and cognitively able to participate in the study Exclusion Criteria: \-
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-01
Estimated completion: 2025-12
Last updated: 2024-06-24
Interventions
Device: Interaktor
Primary outcomes
  • Acceptability E-scale (6 months)
  • System Usability Scale (q5 and q10) (6 months)
  • Interviews with patients and study-specific nurses (7 months)
Sponsor
Karolinska Institutet · other
Contacts & investigators
ContactKristina Rooth, MSc · contact · kristina.rooth@ki.se · 0046707526845
ContactAnn Langius Eklöf, Professor · contact · ann.langius-eklöf@ki.se · 0046722535878
InvestigatorAnn Langius-Eklöf, Professor · principal_investigator, Karolinska Institutet
All locations (1)
Health Care Services Stockholm County (SLSO)Recruiting
Stockholm, Sweden
To Live Better After Breast Cancer Treatment · TrialPath