Supporting Women With Breast Cancer to Practice DIBH at Home Before Radiation Therapy

NCT05791084 | Not Yet Recruiting

• 1 other identifier: 2021-04031
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

To examine the effect of a preparatory digital tool including a new instruction for deep inspiration breath hold (DIBH), before start of radiation therapy in women diagnosed with left sided breast cancer, compared with usual care.

Conditions

Health Literacy; Distress, Emotional; Preparedness; Mobile Application

Keywords

DIBH; RCT; radiotherapy; mobile application; distress

Outcome Measures

Primary Outcomes (5)

• Distress (DIS-A)

  The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.

  Time 1, baseline at randomisation/inclusion

• Distress (DIS-A)

  The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.

  time 2, at CT-planning visit one week

• Distress (DIS-A)

  The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.

  time 3, 3 weeks post RT

• Distress (DIS-A)

  The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.

  time 4, 6 month post RT

• Distress (DIS-A)

  The Distress Thermometer (DT) was developed as a simple tool to effectively screen for symptoms of distress. The instrument is a self-reported tool using a 0-to-10 rating scale, where 0 is no distress and 10 the worst distress.

  time 5, 5 years after RT

Secondary Outcomes (6)

• HRQoL and Health economic (EQ-5D-5L)

  at baseline when inclusion/randomisation

• HRQoL and Health economic (EQ-5D-5L)

  5 years post RT

• e-HL (eHLQ)

  at baseline when inclusion/randomisation

• Communicative, critical and functional HL

  at baseline when inclusion/randomisation

• Preparedness(PCSQ-24)

  at CT planning visit, one week

Other Outcomes (19)

• Logged data from the CT machine

  at Ct planning visit, one week

• Logged data from the CT machine

  at Ct planning visit, one week

• Data from the journal

  at Ct planning visit, one week

Study Arms (2)

A=Control group who receives customary information prior to RT with DIBH.

NO INTERVENTION

Usual care and information before start of radiotherapy with DIBH.

B=Intervention group usual care and the DIBH-App to practice at-home before RT with DIBH.

EXPERIMENTAL

Usual care and information and a mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts.

Other: mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts.

Interventions

mobile application with breathing instructions and a sensor to attach around the chest. To be able to train at home before radiotherapy with DIBH starts. OTHER

The DIBH-App consists of 1) a mobile application that patients download to their own smart mobile phone, and 2) associated stretch-sensors that are attached around the chest and connected to the mobile phone via Bluetooth. Visually, the graphics is similar to the software used for DIBH in the RT department. Coaching takes place through instructional videos, text, and audio recordings (Image 2). The following information will be recorded and stored: date and time of practice, outcome of each session (including sensor data and calibration parameters), and user behavior within the application (such as screen visits, FAQ sections viewed, and key button presses).

B=Intervention group usual care and the DIBH-App to practice at-home before RT with DIBH.

Eligibility Criteria

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

You may qualify if:

• patients \> 18 years of age
• with a left-sided breast cancer diagnosis or DCIS
• who are to receive RT with DIBH technology
• with curative intention
• preparatory CT visit minimum 7 days to a maximum of 4 weeks
• able to speak and understand good enough Swedish to be able to assimilate content in the mobile app and answer surveys and interview questions
• have access to a smart mobile phone.

You may not qualify if:

• patients receiving palliative RT or neoadjuvant chemotherap
• Planning CT starting \< 7 days
• people with some form of orthopedic, rheumatological or neurological injury or disease that limits the possibility of carrying out the intervention.

Sponsors & Collaborators

• Jonkoping University: lead

Study Officials

• maria Brovall, ass prof

  Jonkoping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

maria Brovall, ass prof

CONTACT

+46705501097; maria.brovall@ju.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: associated professor

Model Details: RCT with an intervention and control group

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 30, 2023
• Study Start: September 1, 2023
• Primary Completion: September 30, 2024
• Study Completion (Estimated): March 30, 2029
• Last Updated: March 30, 2023

Record last verified: 2023-03