To Live Better After Breast Cancer Treatment

NCT06471452 | Recruiting DMC

• 1 other identifier: Dnr-2023-02423-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivorship

Keywords

Breast cancer; Mhealth; Supportive care; Symptom management

Outcome Measures

Primary Outcomes (4)

• 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.

  6 months

• 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.

  6 months

• 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.

  7 months

• 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.

  Through study completion, an average of 24 months

Secondary Outcomes (6)

• 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.

• 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.

• Health Literacy CCHL,( 5-items)

  Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.

• 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.

• Patient Activation Measure (PAM-13)

  Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Device: Interaktor

Control group

NO INTERVENTION

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.

Interventions

Interaktor DEVICE

In 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Health Care Services Stockholm County (SLSO)

Stockholm, Sweden

RECRUITING

Related Publications (16)

• Sung 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 BACKGROUND

• Socialstyrelsen. 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.

  BACKGROUND

• Roginski 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 BACKGROUND

• Cardoso 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 BACKGROUND

• Ellegaard 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 BACKGROUND

• Sundquist 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 BACKGROUND

• Tariman 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.

  PMID: 20974066 BACKGROUND

• Lewis, J. R. (2018) The System Usability Scale: Past, Present, and Future, International Journal of Human-Computer Interaction, 34:7, 577-590, DOI: 10.1080/10447318.2018.1455307

  BACKGROUND

• Christie J, O'Halloran P, Stevenson M. Planning a cluster randomized controlled trial: methodological issues. Nurs Res. 2009 Mar-Apr;58(2):128-34. doi: 10.1097/NNR.0b013e3181900cb5.

  PMID: 19289934 BACKGROUND

• Bjelic-Radisic V, Cardoso F, Cameron D, Brain E, Kuljanic K, da Costa RA, Conroy T, Inwald EC, Serpentini S, Pinto M, Weis J, Morag O, Lindviksmoen Astrup G, Tomaszweksi KA, Pogoda K, Sinai P, Sprangers M, Aaronson N, Velikova G, Greimel E, Arraras J, Bottomley A; EORTC Quality of Life Group and Breast Cancer Group. An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45. Ann Oncol. 2020 Feb;31(2):283-288. doi: 10.1016/j.annonc.2019.10.027. Epub 2019 Dec 18.

  PMID: 31959345 BACKGROUND

• Sprangers MA, Cull A, Groenvold M, Bjordal K, Blazeby J, Aaronson NK. The European Organization for Research and Treatment of Cancer approach to developing questionnaire modules: an update and overview. EORTC Quality of Life Study Group. Qual Life Res. 1998 May;7(4):291-300. doi: 10.1023/a:1024977728719.

  PMID: 9610213 BACKGROUND

• Wangdahl JM, Martensson LI. The communicative and critical health literacy scale--Swedish version. Scand J Public Health. 2014 Feb;42(1):25-31. doi: 10.1177/1403494813500592. Epub 2013 Aug 27.

  PMID: 23982461 BACKGROUND

• Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.

  PMID: 15230939 BACKGROUND

• Eriksson M, Lindstrom B. Validity of Antonovsky's sense of coherence scale: a systematic review. J Epidemiol Community Health. 2005 Jun;59(6):460-6. doi: 10.1136/jech.2003.018085.

  PMID: 15911640 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Langius-Eklof A, Craftman AG, Gellerstedt L, Kelmendi N, Rooth K, Gustavell T, Sundberg K. Digital and nurse-led support intervention in primary care during the first year after curative intent treatment for breast or prostate cancer: study protocol of two cluster randomised controlled pilot trials. BMJ Open. 2025 Feb 22;15(2):e090848. doi: 10.1136/bmjopen-2024-090848.

  PMID: 39986997 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ann Langius-Eklöf, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Rooth, MSc

CONTACT

0046707526845; kristina.rooth@ki.se

Ann Langius Eklöf, Professor

CONTACT

0046722535878; ann.langius-eklöf@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: June 24, 2024
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)