To Live Better After Breast Cancer Treatment
ConditionBreast Cancer Survivorship
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Interaktor
DeviceIn the app (Interaktor), the patients will report frequency and distress on common symptoms and concerns. Free text comments will also be possible to make to cover the patients' other potential needs. Information about the concerns will be included in the app containing; a) general information about why they have the side effects and what it means b) evidence-based advice about self-management; c) when they should contact health care providers, and d) further information linked to reliable documents, web pages or YouTube videos. Supportive Care delivered from a study-specific nurse. During the health dialogues with a nurse, the patient-reported assessments in the app will be used to discuss the individual's current situation and needs and to plan eventual additional actions needed such as support from a physiotherapist, social worker, dietitian or if a visit to the physician if needed. This is documented in the patient's journal.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Acceptability E-scale
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.
Time frame
6 months2
System Usability Scale (q5 and q10)
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.
Time frame
6 months3
Interviews with patients and study-specific nurses
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.
Time frame
7 months4
Other feasibility measures
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.
Time frame
Through study completion, an average of 24 monthsSecondary outcomes
1
Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module BR45.
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.
Time frame
Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.2
Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - C30.
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.
Time frame
Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.3
Health Literacy CCHL,( 5-items)
The questionnaire has five items measuring the ability to read and understand information regarding health, disease and healthcare.
Time frame
Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.4
Quality of life measured measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)
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.
Time frame
Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.Sponsors and contacts
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Source ClinicalTrials.gov