Clinical trial NCT04394325: Digi-Do - a Digital Information Tool to Help Patients Diagnosed With Breast Cancer
Official title: Digi-Do - a Digital Information Tool to Help Patients Diagnosed With Breast Cancer to be Involved and Prepared Before, During, and After Start of Radiotherapy Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Digital Technology
Radiotherapy (RT)
Patient information
Virtual Reality (VR)
Lead sponsor: Jonkoping University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project uses participatory design combined with qualitative and quantitative methods to develop, explore and evaluate the usefulness of a digital information tool to prepare and support patients before, during and after RT as treatment for breast cancer.

Detailed description: The study is a prospective and longitudinal Randomised Control Trial (RCT) study with an Action Research (AR) participatory design approach, including mixed-method data collection, i.e., standardised instruments, interviews (face-to-face and telephone), diaries, observation, and time measurements. The timeline for the study is scheduled between autumn 2020 to spring 2022. The study will consist of two arms: A) an intervention group (n=80), who will receive standard care and information and the digital information tool; and B) a control group (n=80) who will receive standard care and information (verbal and written). Recruitment and randomisation will be completed at two hospitals in the South western part of Sweden.

As a pre-phase, a pilot study was performed for the development and testing of the digital information tool (Digi-Do), approved by the Regional Ethics Committee (Dnr 917-17) with 30 patients in total (15 women with breast cancer and 15 men with prostate cancer). According to the study's co-design, iterative methodology \[26-27 in manuscript\], changes have since been made to the digital information tool and a second version has now been developed for the full RCT. The present study has been approved by the Swedish Ethical Review Authority (Dnr 2020-00170). An ongoing systematic literature review will also guide the present study, and the project is registered in PROSPERO (PROSPERO;168073).

The digital information tool applied in this project is divided into two separate but coherent applications (apps) for mobile devices: one (VR-app) with a guided tour of the RT-department with a voice-over to describe 360 images to create a sense of actually having visited the department prior to start of RT, and one (information app) containing information obtained through the pre-treatment phase. If a VR-effect is not desirable, the patient can complete the simulated study-visit on their mobile phone or tablet as well as present the images in the browser of an integrated media player. Three areas of information are available in the information app: 1) Q\&As from the existing written information, presented both in writing and a recorded voice; 2) practical information, such as maps, public transportation options with relevant links to public transport, telephone numbers, and information about possibilities for staying at the patient hotel; and 3) three short animated films about cancer and physical activity during RT.

Eligibility criteria: Inclusion Criteria:

Adult patients (\>18 years):

* diagnosed with breast cancer, stage I-II not receiving adjuvant or neo-adjuvant chemotherapy or anti-Her-2 treatment and
* with RT as additional treatment after surgery.
* ability to read, write and understand Swedish enough to adhere to the digital information tool and the applied instruments.
* that have access to a smartphone.

Exclusion Criteria:

* not receiving RT have had RT before
* diagnosed with dementia

Primary outcomes:
measure: Change in distress
timeFrame: Baseline pre intervention
measure: Change in distress
timeFrame: up to one week of intervention
measure: Change in distress
timeFrame: 6 months after the intervention
Secondary outcomes:
measure: Change in general self-efficacy
timeFrame: Baseline pre intervention
measure: Change in general self-efficacy
timeFrame: 6 months after the intervention
measure: Change in communicative and critical health literacy
timeFrame: Baseline pre intervention
measure: Change in communicative and critical health literacy
timeFrame: 6 months after the intervention
measure: Change in functional health literacy
timeFrame: Baseline pre intervention
measure: Change in functional health literacy
timeFrame: 6 months after the intervention
measure: Change in eHealth literacy
timeFrame: Baseline pre intervention
measure: Change in eHealth literacy
timeFrame: 6 months after the intervention
measure: Time measurements and Observations
timeFrame: up to one week of intervention
measure: Time measurements and Observations
timeFrame: up to five week of intervention
Other outcomes:
measure: In-depth interviews
timeFrame: 1 week after the intervention
measure: In-depth interviews
timeFrame: 6 months after the intervention
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska universitetssjukhuset
Study officials:
affiliation: Jonkoping Univeristy Box 1026, 551 11 Jonkoping
name: maria brovall
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fristedt S, Smith F, Grynne A, Browall M. Digi-Do: a digital information tool to support patients with breast cancer before, during, and after start of radiotherapy treatment: an RCT study protocol. BMC Med Inform Decis Mak. 2021 Feb 25;21(1):76. doi: 10.1186/s12911-021-01448-3.