NCT02479607

Brief Summary

The purpose of this study is to evaluate the effects of an interactive Information and Communication Technologies (ICT) -platform for use in a smartphone or tablet in patients treated with neoadjuvant chemotherapy for breast cancer. The hypothesis is that clinical management will be improved and costs reduced and safe and participatory care promoted, when patients report symptoms in an application which provides self-care advice and instant access to professionals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

June 30, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

2.3 years

First QC Date

June 12, 2015

Last Update Submit

August 7, 2018

Conditions

Breast Cancer

Keywords

Breast CancerCytostatic AgentsNursingHealth LiteracyQuality of LifeOncology NursingSelf CareSymptom ManagementParticipatory CarePerson-centered CareInformation and Communication TechnologyPatient-reported symptomsMobile device

Outcome Measures

Primary Outcomes (6)

  • Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)

    To evaluate self-reported data in terms of understanding health

    Up to 3 months after completion of neoadjuvant chemotherapy treatment

  • Questionnaire Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)

    To evaluate self-reported data in terms of communicating health

    Up to 3 months after completion of neoadjuvant chemotherapy treatment

  • Questionnaire Individualized Care Scale (ICS)

    To evaluate self-reported data in terms of individualized care

    Up to 3 months after completion of neoadjuvant chemotherapy treatment

  • Questionnaire Sense of Coherence Scale (KASAM)

    To evaluate self-reported data in terms of Sense of Coherence

    Up to 3 months after completion of neoadjuvant chemotherapy treatment

  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)

    To evaluate self-reported data in terms of health related quality of life

    Up to 3 months after completion of neoadjuvant chemotherapy treatment

  • Questionnaire Memorial Symptom Assessment Scale (MSAS)

    To evaluate self-reported data in terms of symptom prevalence, characteristics and distress

    Up to 3 months after completion of neoadjuvant chemotherapy treatment

Secondary Outcomes (1)

  • Health care costs

    Up to 3 months after completion of neoadjuvant chemotherapy treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

Use of an application for a smartphone or tablet for daily reporting symptoms and access to self-care advice and health care professionals in real time in combination with standard care according to the clinic´s routines

Device: Smartphone or tablet

Control group

NO INTERVENTION

Standard care according to the clinic's routines.

Interventions

Smartphone or tabletDEVICE
Also known as: Intervention
Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The diagnosis of breast cancer
  • Patients who will receive neoadjuvant chemotherapy
  • Literacy in the Swedish language

You may not qualify if:

  • Patients who need an interpreter at the doctor's visit
  • Patients who have a known severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (2)

  • Crafoord MT, Ekstrand J, Sundberg K, Nilsson MI, Fjell M, Langius-Eklof A. Mobile Electronic Patient-Reported Outcomes and Interactive Support During Breast and Prostate Cancer Treatment: Health Economic Evaluation From Two Randomized Controlled Trials. JMIR Cancer. 2025 Mar 11;11:e53539. doi: 10.2196/53539.

    PMID: 40067346DERIVED

  • Langius-Eklof A, Crafoord MT, Christiansen M, Fjell M, Sundberg K. Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer. BMC Cancer. 2017 Jul 4;17(1):466. doi: 10.1186/s12885-017-3450-y.

    PMID: 28676102DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Ann Langius-Eklöf, RN, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD, Professor

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 24, 2015

Study Start

June 30, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

SE(1)