Clinical trial · Interventional
To Live Better After Breast Cancer Treatment
To Live Better After Breast Cancer Treatment - a Randomized Pilot Trial of a Supportive and Person-centered Care Intervention in Primary Healthcare
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivorship | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interaktor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- 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.
- interventionNames
- Device: Interaktor
- type
- NO_INTERVENTION
- label
- Control group
- description
- The participants in the control group will only receive standard care in the secondary care setting. Usually after ended primary treatment the follow-up is determined based on the severity of the tumour, the received postoperative treatment and the patient's general health status. Patients should be offered a yearly follow-up for at least five years where the patients are made a part of the decision-making process of the structure of the follow-up. All patients are allocated a contact nurse with a telephone number to contact when needed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: \-
References
Publications (16)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDSocialstyrelsen. Statistik om nyupptäckta cancerfall 2021. https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/statistik/2022-12-8308.pdf: Sveriges officiella statistik Hälsa och sjukvård; 2022. p. 5.
- BACKGROUNDRoginski M, Sifaki-Pistolla D, Stomby A, Velivasaki G, Faresjo T, Lionis C, Faresjo A. Paradoxes of breast cancer incidence and mortality in two corners of Europe. BMC Cancer. 2022 Nov 2;22(1):1123. doi: 10.1186/s12885-022-10243-w. PMID 36319987
- BACKGROUNDCardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio IT, Zackrisson S, Senkus E; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-updagger. Ann Oncol. 2019 Aug 1;30(8):1194-1220. doi: 10.1093/annonc/mdz173. No abstract available. PMID 31161190
- BACKGROUNDEllegaard MB, Grau C, Zachariae R, Jensen AB. Women with breast cancer report substantially more disease- and treatment-related side or late effects than registered by clinical oncologists: a cross-sectional study of a standard follow-up program in an oncological department. Breast Cancer Res Treat. 2017 Aug;164(3):727-736. doi: 10.1007/s10549-017-4301-x. Epub 2017 May 23. PMID 28536950
- BACKGROUNDSundquist K, Malmstrom M, Johansson SE, Sundquist J. Care Need Index, a useful tool for the distribution of primary health care resources. J Epidemiol Community Health. 2003 May;57(5):347-52. doi: 10.1136/jech.57.5.347. PMID 12700218
- BACKGROUNDTariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8. doi: 10.1016/j.apnr.2009.04.003. Epub 2009 Sep 18.