Health TrialsbyHealthPanel

Utility of a Mobile Application for Young Women With Breast Cancer

ConditionsBreast CancerCancer Distress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorWake Forest University Health Sciences

About this trial

This study aims to evaluate the use of mobile technology as a communication tool among patients with breast cancer and measured its effect on patient-reported cancer-related distress, specifically focusing on young women as they often face unique challenges.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and willingness to sign an IRB-approved informed consent

Age ≥ 18 and ≤ 45 years at the time of consent

Female

Established patient at Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mighty Pro Application

    Other intervention

    Access to Mighty Pro Application

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Access to the Mighty Pro ApplicationExperimental treatment 1 intervention
Group B: No Access to the Mighty Pro ApplicationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Stage 1: Feasibility of Implementation of Mighty Pro App

Binary variable indicating if at least one encounter with the application occurred for at least 80% of the weeks during the observation period. At the Participant level, the scale is either 0 (less than 80% utilization of the Mighty Pro App at least once per week during the 26-week observation period) or 1 (80% or greater utilization of the Mighty Pro App App at least once per week during the the 26-week observation period).

Time frame
26 Weeks
2

Stage 2: Efficacy of the Mighty Pro App

Binary variable indicating if at least a 2-point improvement was achieved from baseline to 26 weeks. At the Participant level, the scale is either 0 (the study participant did not achieve at least a 2-point improvement from baseline to 26 weeks on the distress scale) or 1 (the study participant did achieve at least a 2-point improvement from baseline to 26 weeks on the distress scale). The distress scale ranges from 0 (no distress) to 10 (extreme distress).

Time frame
26 Weeks

Secondary outcomes

1

Efficacy of the Mighty Pro App in Improving Distress Scores

Binary variable indicating if at least a 2-point improvement was achieved from baseline to 52 weeks. At the Participant level, the scale is either 0 (the study participant did not achieve at least a 2-point improvement from baseline to 52 weeks on the distress scale) or 1 (the study participant did achieve at least a 2-point improvement from baseline to 52 weeks on the distress scale). The distress scale ranges from 0 (no distress) to 10 (extreme distress).

Time frame
52 Weeks
2

Efficacy of the Mighty Pro App in Improving Distress Scores - Quantitative

Quantitative distress scores collected for each participant and for each time point. For each Participant and each time point a quantitative measure will be collected ranging from 0 (no distress) to 10 (extreme distress).

Time frame
52 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Atrium Health Levine Cancer Institute

Collaborator

Source ClinicalTrials.gov
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