Trial Outcomes & Findings for App-Assisted Day Reconstruction to Reduce Logistic Toxicity in Cancer (NCT NCT05502302)

NCT ID: NCT05502302

Last Updated: 2024-07-03

Results Overview

Number of Interviews completed to help identify themes to develop a cancer-specific, multi-tiered activity/trip classification system to organize cancer treatment-related activities and trips in the app; and user stories to describe what the users want to do with the proposed app. 45-minute interviews.

Recruitment status

COMPLETED

Target enrollment

23 participants

Primary outcome timeframe

7 months

Results posted on

2024-07-03

Participant Flow

Participant milestones

Participant milestones
Measure
Cancer Patients
Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios.
Overall Study
STARTED
23
Overall Study
COMPLETED
15
Overall Study
NOT COMPLETED
8

Reasons for withdrawal

Reasons for withdrawal
Measure
Cancer Patients
Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios.
Overall Study
Lost to Follow-up
6
Overall Study
Death
2

Baseline Characteristics

App-Assisted Day Reconstruction to Reduce Logistic Toxicity in Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cancer Patients
n=23 Participants
Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
n=5 Participants
Age, Categorical
>=65 years
7 Participants
n=5 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
Race (NIH/OMB)
White
17 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Region of Enrollment
United States
23 participants
n=5 Participants

PRIMARY outcome

Timeframe: 7 months

Number of Interviews completed to help identify themes to develop a cancer-specific, multi-tiered activity/trip classification system to organize cancer treatment-related activities and trips in the app; and user stories to describe what the users want to do with the proposed app. 45-minute interviews.

Outcome measures

Outcome measures
Measure
Cancer Patients
n=23 Participants
Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios.
Interviews
20 Interviews

PRIMARY outcome

Timeframe: 7 months

Participants with overall satisfaction with proposed system design will be measured using a 5-point Likert scale from not at all satisfied to very satisfied. The primary endpoint will be the proportion of participants who report an overall satisfaction score of 4.0 or above. 10-Minutes.

Outcome measures

Outcome measures
Measure
Cancer Patients
n=15 Participants
Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios.
Satisfaction Score Follow-Up Survey
80 Percentage of participants

Adverse Events

Cancer Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rachel Vogel

University of Minnesota, Masonic Cancer Center

Phone: 612-624-6928

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place