NCT06185738

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

December 15, 2023

Last Update Submit

December 5, 2025

Conditions

Outcome Measures

Primary Outcomes (13)

  • 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

Study Arms (1)

WCM app

OTHER

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

Interventions

WCM appOTHER

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

WCM app

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsHead and Neck NeoplasmsSarcoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 15, 2023

First Posted

December 29, 2023

Study Start

July 1, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

December 15, 2025

Record last verified: 2025-12

Locations