WeCanManage. An mHealth Self-management Tool

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Head and Neck Cancer, Sarcoma

Intervention / Treatment
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* Other: WCM app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: WCM app<br>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<br>* 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<br>|

What is the study measuring?
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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 |