Clinical trial NCT06185738: WeCanManage. An mHealth Self-management Tool
Official title: WeCanManage: An mHealth Self-management Tool to Empower Survivors With Disabilities Due to Long-term Effects of Cancer and Its Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Head and Neck Cancer
Sarcoma
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Northeastern Illinois University
First posted: 2023-12-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will have a data collection session by phone lasting about 60 minutes, and to complete a demographic and health questionnaire, that includes questions such as sex, age, race, ethnicity, marital status, cancer type, time since diagnosis, date of diagnosis, stage of illness, type of primary treatment, type of disability, current activity level, health conditions, annual income, educational history.

WeCanManage (WCM) app orientation by Zoom lasting about 60 minutes. Participants will complete WCM app program, about 10 minutes per day for 30 days and up to 45 days. Data collection by phone lasting about 60 minutes after completion of WCM app program and 4 weeks after completion of WCM app program All participants will have an intervention of 4 modules (WeCanRelate, WeCanAdapt, WeCanBe, and WeCanSpeakUp) that are presented as series of micro-learning sessions
Primary purpose: SUPPORTIVE_CARE

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of WCM app
timeFrame: 1 year
measure: Feasibility of WCM app
timeFrame: 1 year
measure: Acceptability of WCM app
timeFrame: 1 year
measure: Acceptability of WCM app
timeFrame: 1 year
measure: Acceptability of WCM app
timeFrame: 1 year
measure: Acceptability of WCM app
timeFrame: 1 year
measure: Acceptability of WCM app
timeFrame: 1 year
measure: Feasibility with WCM app
timeFrame: Baseline
measure: Feasibility with WCM app
timeFrame: 4 Weeks
measure: Feasibility with WCM app
timeFrame: 8 Weeks
measure: Feasibility with WCM app
timeFrame: Baseline
measure: Feasibility with WCM app
timeFrame: 4 weeks
measure: Feasibility with WCM app
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
Study officials:
References: