To Live Better After Breast Cancer Treatment
- Conditions
- Breast Cancer Survivorship
- Interventions
- Device: Interaktor
- Registration Number
- NCT06471452
- Lead Sponsor
- Karolinska Institutet
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Interaktor The intervention consists of standard care and the app (called Interaktor) for routine symptom reporting of common symptoms regarding fatigue, emotional distress, sleep, pain, loss of appetite, hot flashes/sweating, edema, and sexual health, in combination with health dialogues with a study-specific nurse. The reports are made weekly during the first month and thereafter as mutually agreed, at minimum once a month for six months, with instant self-care advice in combination with supportive care with a study-specific nurse. At health dialogues with the study-specific nurse, the patient-reported assessments in the app will be used to discuss the individual's current situation and to plan eventual additional actions needed. The intervention will last for 6 months.
- Primary Outcome Measures
Name Time Method Interviews with patients and study-specific nurses 7 months To assess acceptability and feasibility, the participants in the intervention group and the study-specific nurses will be interviewed about their experience of using the Interaktor system and about the health dialogues.
Acceptability E-scale 6 months The Acceptability e-scale is a questionnaire with 6 items that evaluate the acceptability of a system. Items are scored using a Likert scale ranging from 1-5 with higher values indicating higher acceptability.
System Usability Scale (q5 and q10) 6 months The System Usability Scale is a questionnaire with ten items that evaluate the usability of a system. Items are scored using a Likert scale ranging from 1-5. only question 5 and 10 will be included in this study.
Other feasibility measures Through study completion, an average of 24 months To evaluate the feasibility of the future trial methodology, enrollment, recruitment, and withdrawal rates will be documented. Other feasibility measures include completion rates and missing data in each study questionnaire. Objective measures will be extracted from the logged data in the app, i.e., the number of reports sent (adherence), self-care advice viewings, and notes from the study-specific nurses.
- Secondary Outcome Measures
Name Time Method Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - C30. Baseline, 3 months, 6 months, 12 months, 18 months and 24 months. The questionnaire has 30 items divided in five functional scales (physical, role, emotional, social, and cognitive), eight symptom scales (fatigue, nausea and vomiting, pain, insomnia, appetite loss, constipation, diarrhea), financial impact of the disease, and a global health status/QoL scale. Questions are scored using a Likert scale ranging from 1-4 with higher values indicating lower QoL.
Health Literacy CCHL,( 5-items) Baseline, 3 months, 6 months, 12 months, 18 months and 24 months. The questionnaire has five items measuring the ability to read and understand information regarding health, disease and healthcare.
Quality of life measured measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Baseline, 3 months, 6 months, 12 months, 18 months and 24 months. The EQ-5D-5L is a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Patient Activation Measure (PAM-13) Baseline, 3 months, 6 months, 12 months, 18 months and 24 months. The PAM-13 questionnaire has 13 items measure knowledge, skills, beliefs, and confidence in managing health and healthcare.
The Sense of Coherence Scale (SOC-13) Baseline, 3 months, 6 months, 12 months, 18 months and 24 months. The SOC-13 questionnaire measure overall coping ability.
Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module BR45. Baseline, 3 months, 6 months, 12 months, 18 months and 24 months. The questionnaire has 45 items and evaluates specific breast cancer symptoms related to treatment such as fatigue, apatite and sexual health. Items are scored using a Likert scale ranging from 1-4 with higher values indicating more burden of symptoms.
Trial Locations
- Locations (1)
Health Care Services Stockholm County (SLSO)
🇸🇪Stockholm, Sweden