WeCanManage. An mHealth Self-management Tool

Breast Cancer Clinical Trial

Official title:

WeCanManage: An mHealth Self-management Tool to Empower Survivors With Disabilities Due to Long-term Effects of Cancer and Its Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06185738
• Other study ID #: 2020-1067
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Examine the Feasibility, Acceptability, User Satisfaction, and Response Patterns and Preliminary Efficacy on Targeted Patient Reported Outcomes. Using a pre-post, single arm feasibility design with cancer survivors with disabilities

Description:

Examine the Feasibility, Acceptability, User Satisfaction, and Response Patterns and Preliminary Efficacy on Targeted Patient Reported Outcomes. Using a pre-post, single arm feasibility design with cancer survivors with disabilities, we will collect data on the WeCanManage app delivered self-management intervention's feasibility, acceptability, user satisfaction as well as response patterns and preliminary efficacy on targeted patient reported outcomes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Usability Testing of the WeCanManage High Fidelity Prototype

• Age 18 or older

• Diagnosis of breast cancer, head and neck cancer or sarcoma

• Completion of active treatment

• Self-identify as a person with a disability according to the Americans with Disabilities .Act and the American Community Survey 6-disability questions

• Able to understand and communicate in English

• Medically stable enough to participate in two data collection sessions totaling 2 hours

Evaluation of the WeCanManage App

• Age 18 or older

• Diagnosis of breast cancer, head and neck cancer or sarcoma

• Completion of primary (i.e. surgery, chemotherapy, and/or radiation); may still be under-going endocrine or hormone therapies

• Self-identify as experiencing disabling after-effects of cancer and its treatment according to the Americans with Disabilities Act and the American Community Survey 6-disability questions

• Able to read, understand and communicate in English

• Ownership of a smartphone, tablet, or personal computer.

• Internet access

Exclusion Criteria:

Usability Testing of the WeCanManage High Fidelity Prototype

• No diagnosis of breast cancer, head and neck cancer or sarcoma

• In active treatment

• Does not self-identify as a person with a disability according to the Americans with Disabilities Act and the American Community Survey 6-disability questions

• Not able to understand and communicate in English

• Not medically stable enough to participate in two data collection sessions totaling 2 hours

Evaluation of the WeCanManage App

• Age 17 or younger

• No diagnosis of breast cancer, head and neck cancer or sarcoma

• In active treatment

• Does not self-identify as experiencing long-term effects of cancer and its treatment according to the Americans with Disabilities Act and the American Community Survey 6-disability questions

• Not able to read, understand, and communicate in English

• Does not have access to internet enabled smartphone, tablet, or personal computer

• Does not have access to the internet

Related Conditions & MeSH terms

• Breast Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Sarcoma

Intervention

Other:
• WCM app
WCM app evaluation at baseline, at completion of WCM program and 4 weeks after completion of WCM program, by completing PROMIS and Self Efficacy for managing disease scale questionnaires

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Northeastern Illinois University, Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of WCM app	Evaluate recruitment capability by assessing response rate	1 year
Primary	Feasibility of WCM app	Number of participants that started the intervention from consent	1 year
Primary	Acceptability of WCM app	Number of participants that adhered to the intervention	1 year
Primary	Acceptability of WCM app	Number of participants that were engaged in the intervention	1 year
Primary	Acceptability of WCM app	Number of participants that were satisfied with the intervention	1 year
Primary	Acceptability of WCM app	Number of participants that found the intervention helpful	1 year
Primary	Acceptability of WCM app	Number of participants that wished to continue using the intervention l	1 year
Primary	Feasibility with WCM app	Measurement of PROMIS questionnaire, low score health good, high score health not good	Baseline
Primary	Feasibility with WCM app	Measurement of PROMIS questionnaire, low score health good, high score health not good	4 Weeks
Primary	Feasibility with WCM app	Measurement of PROMIS questionnaire, low score health good, high score health not good	8 Weeks
Primary	Feasibility with WCM app	Measurement of Self Efficacy for managing disease scale questionnaire, low score not confident, high score very confident	Baseline
Primary	Feasibility with WCM app	Measurement of Self Efficacy for managing disease scale questionnaire, low score not confident, high score very confident	4 weeks
Primary	Feasibility with WCM app	Measurement of Self Efficacy for managing disease scale questionnaire, low score not confident, high score very confident	8 weeks