Clinical trial NCT06471452: To Live Better After Breast Cancer Treatment
Official title: To Live Better After Breast Cancer Treatment - a Randomized Pilot Trial of a Supportive and Person-centered Care Intervention in Primary Healthcare
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Survivorship
Keywords: Breast cancer
Mhealth
Supportive care
Symptom management
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The most common cancer among women in Sweden is breast cancer. Advances in treatment have improved survival, but these advances have come at a steep price since most treatments impose substantial morbidity and burden on patients and their families. Furthermore, many survivors from cancer have ongoing poor health and well-being and long-term rehabilitation and support should not be neglected to prevent recurrence and increase survival. There are good reasons to believe that routine collection of relevant patient-reported symptoms facilitates person-centered care where the patient is a participatory member of the team. This study aims to pilot-test a supportive and person-centered care intervention in primary healthcare for six months during the first year after primary treatment for breast cancer, assisted by digital technology and compare it to standard care only. The intervention consists of symptom reporting and management in an app in combination with health dialogues with a study-specific nurse at the Primary healthcare centre.

Detailed description: 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:

-

Primary outcomes:
measure: Acceptability E-scale
timeFrame: 6 months
measure: System Usability Scale (q5 and q10)
timeFrame: 6 months
measure: Interviews with patients and study-specific nurses
timeFrame: 7 months
measure: Other feasibility measures
timeFrame: Through study completion, an average of 24 months
Secondary outcomes:
measure: Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module BR45.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.
measure: Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - C30.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.
measure: Health Literacy CCHL,( 5-items)
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.
measure: Quality of life measured measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.
measure: Patient Activation Measure (PAM-13)
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.
measure: The Sense of Coherence Scale (SOC-13)
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Health Care Services Stockholm County (SLSO)
Study officials:
affiliation: Karolinska Institutet
name: Ann Langius-Eklöf, Professor
role: PRINCIPAL_INVESTIGATOR
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