Assessing the Time Demands of Cancer

Ovarian Cancer Clinical Trial

Official title:

Time Toxicity of Cancer: the Time Demands of Cancer-related Activities and Their Impact on Well-being and Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708703
• Other study ID #: 2022LS100
• Status: Recruiting
• Start date: November 13, 2023
• Est. completion date: December 31, 2030

Study information

• Verified date: November 2023
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Rachel Vogel
• Phone: 612-624-6928
• Email: isak0023[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A total of 80 individuals receiving treatment for metastatic breast or advanced stage ovarian cancer will be asked to complete a baseline survey and install the mobile app on their smartphone; carry the smartphone for 28 consecutive days while outside the home; keep smartphone location and motion services active; confirm and correct (if needed) smartphone-detected activities and trips; use the app interface to provide additional information on activities and trips related to cancer treatment tasks; complete daily surveys regarding well-being; and at the end of the 28 day period, complete an online survey.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older
• Diagnosed with advanced stage (III, IV) ovarian (ovarian, fallopian tube or prmary peritoneal) or metastatic breast cancer [do not need to be newly diagnosed]
• Currently receiving any type of therapy for their cancer [can be front-line, maintenance therapy, or treatment for recurrence]
• Able to complete study tasks in English
• Able to provide voluntary informed consent
• Own an Android or iOS smartphone on which the operating system is version 9.0 or higher for Android or 10.0 higher for iOS; or willing to use a researcher-provided smartphone

Exclusion Criteria:

• Those who are currently incarcerated
• Have opted out of research contact

Related Conditions & MeSH terms

• Metastatic Breast Cancer
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	Masonic Cancer Center - University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity and trip types	Using the mobile app smartphone collected data, compute number of different activity or trip types.	28 days
Primary	Activity length	Using the mobile app smartphone collected data, compute the number of minutes per day spent on different activities.	28 days
Primary	Activity reoccurrence	Using the mobile app smartphone collected data, compute separate activity episodes and frequency per week.	28 days