Digi-Do - a Digital Information Tool to Help Patients Diagnosed With Breast Cancer

NCT04394325 | Completed

• 1 other identifier: JU 2020/1732-51
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Digital Technology; Radiotherapy (RT); Patient information; Virtual Reality (VR)

Outcome Measures

Primary Outcomes (3)

• Change in distress

  The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress

  Baseline pre intervention

• Change in distress

  The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress

  up to one week of intervention

• Change in distress

  The National Comprehensive Cancer Network Distress Thermometer is a brief screening tool for cancer patients to assess psychosocial distress

  6 months after the intervention

Secondary Outcomes (10)

• Change in general self-efficacy

  Baseline pre intervention

• Change in general self-efficacy

  6 months after the intervention

• Change in communicative and critical health literacy

  Baseline pre intervention

• Change in communicative and critical health literacy

  6 months after the intervention

• Change in functional health literacy

  Baseline pre intervention

Other Outcomes (2)

• In-depth interviews

  1 week after the intervention

• In-depth interviews

  6 months after the intervention

Study Arms (2)

Group A) Intervention group

EXPERIMENTAL

Group A) an intervention group (n=80) who will receive the standard care and information (oral and written) + the digital information tool.

Behavioral: Digital information tool

Group B) Control group

NO INTERVENTION

Group B) a control group (n=80) who will receive standard care and information (oral and written).

Interventions

Digital information tool BEHAVIORAL

The patients randomized to group A will receive verbal and written information regarding the digital information tool and how to use it, as well as verbal and written information about the study. They will also receive information about the different instruments and surveys they will be asked to answer at different occasions during the RT treatment period. The applied instruments for data collection will be administrated in person or by post at the baseline collection and by post (including pre-paid return envelope) on consecutive collections. Approximately 30 patients (in group A) will be asked to make regular notes in a notebook during the waiting period prior start of RT as well as during RT treatment period. Following completion of the RT treatment period individual in-depth and telephone interviews will take place with 10-12 patients that accept participation.

Group A) Intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jonkoping University: lead

Study Sites (1)

Sahlgrenska universitetssjukhuset

Gothenburg, 41345, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33632215 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• maria brovall

  Jonkoping Univeristy Box 1026, 551 11 Jonkoping

  PRINCIPAL INVESTIGATOR

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: Associate Professor

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 19, 2020
• Study Start: September 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: November 30, 2023
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)