To Live Better After Breast Cancer Treatment

June 18, 2024 updated by: Ann Langius-Eklöf, Karolinska Institutet

To Live Better After Breast Cancer Treatment - a Randomized Pilot Trial of a Supportive and Person-centered Care Intervention in Primary Healthcare

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Health Care Services Stockholm County (SLSO)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

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

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.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability E-scale
Time Frame: 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.
6 months
System Usability Scale (q5 and q10)
Time Frame: 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.
6 months
Interviews with patients and study-specific nurses
Time Frame: 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.
7 months
Other feasibility measures
Time Frame: 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.
Through study completion, an average of 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module BR45.
Time Frame: 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.
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.
Time Frame: 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.
Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.
Health Literacy CCHL,( 5-items)
Time Frame: 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.
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)
Time Frame: 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.
Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.
Patient Activation Measure (PAM-13)
Time Frame: 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.
Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.
The Sense of Coherence Scale (SOC-13)
Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.
The SOC-13 questionnaire measure overall coping ability.
Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Ann Langius-Eklöf, Professor, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr-2023-02423-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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