WeCanManage. An mHealth Self-management Tool

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoma; Breast Cancer; Head and Neck Cancer
• Intervention / Treatment: Other: WCM app

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: WCM app; WCM app evaluation at baseline, upon completion of WCM program and 4 weeks after completion of WCM program, by completing PROMIS and Self Efficacy for managing disease scale questionnaires	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Northwestern University; Northeastern Illinois University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2020-1067

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No