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Spots Global Cancer Trial Database for Mobile Health for Adherence in Breast Cancer Patients

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Trial Identification

Brief Title: Mobile Health for Adherence in Breast Cancer Patients

Official Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Study ID: NCT06112613

Study Description

Brief Summary: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the WiseBag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

Detailed Description: PRIMARY OBJECTIVE: I. To compare CDK4/6 inhibitors (CDK4/6i) adherence at 12 months after completion of the baseline survey captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms. SECONDARY OBJECTIVES: I. To compare CDK4/6i adherence at 12 months after completion of the baseline survey captured through self-report between the EUC (Arm A) and CONCURxP (Arm B) arms. II. To compare CDK4/6i persistence at 12 months after completion of the baseline survey captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms. III. To compare symptom burden at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. IV. To compare quality of life at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. V. To compare patient-provider communication at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. VI. To compare self-efficacy for managing symptoms at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. VII. To compare financial worry at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. EXPLORATORY OBJECTIVES: I. To assess longitudinal changes of patient-reported outcomes (self reported adherence, symptom burden, quality of life, and financial worry) from the EUC (Arm A) and CONCURxP (Arm B) arms. II. To compare healthcare utilization at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. III. To compare progression-free survival at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. IV. To compare overall survival at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. V. To describe CONCURxP (Arm B) patients and their provider experience with various implementation outcomes. OUTLINE: Patients are randomized into 1 of 2 arms. Non-patient participants are assigned to arm C. ARM A: Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months. ARM B: Patients use the WiseBag medication dispenser and receive personalized text message reminders, medication tracking and healthcare provider follow ups as part of the CONCURxP platform over 12 months. Patients may complete an interview over 20-30 minutes within 6 months of study completion. ARM C: Participants complete an interview over 20-30 minutes 15-39 months post-first patient enrollment. After completion of study intervention, patients may be followed up to 6 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States

CARTI Cancer Center, Little Rock, Arkansas, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene, Coeur d'Alene, Idaho, United States

Walter Knox Memorial Hospital, Emmett, Idaho, United States

Idaho Urologic Institute-Meridian, Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States

Kootenai Cancer Clinic, Sandpoint, Idaho, United States

Saint Anthony's Health, Alton, Illinois, United States

Rush - Copley Medical Center, Aurora, Illinois, United States

Saint Mary's Hospital, Centralia, Illinois, United States

Carle at The Riverfront, Danville, Illinois, United States

Carle Physician Group-Effingham, Effingham, Illinois, United States

Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States

Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States

Carle Cancer Center, Urbana, Illinois, United States

Rush-Copley Healthcare Center, Yorkville, Illinois, United States

Mary Greeley Medical Center, Ames, Iowa, United States

McFarland Clinic - Ames, Ames, Iowa, United States

McFarland Clinic - Boone, Boone, Iowa, United States

Mercy Hospital, Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States

McFarland Clinic - Trinity Cancer Center, Fort Dodge, Iowa, United States

McFarland Clinic - Jefferson, Jefferson, Iowa, United States

McFarland Clinic - Marshalltown, Marshalltown, Iowa, United States

Central Care Cancer Center - Garden City, Garden City, Kansas, United States

Central Care Cancer Center - Great Bend, Great Bend, Kansas, United States

Minnesota Oncology - Burnsville, Burnsville, Minnesota, United States

Cambridge Medical Center, Cambridge, Minnesota, United States

Mercy Hospital, Coon Rapids, Minnesota, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove, Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States

Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Hennepin County Medical Center, Minneapolis, Minnesota, United States

Health Partners Inc, Minneapolis, Minnesota, United States

Monticello Cancer Center, Monticello, Minnesota, United States

New Ulm Medical Center, New Ulm, Minnesota, United States

Fairview Northland Medical Center, Princeton, Minnesota, United States

North Memorial Medical Health Center, Robbinsdale, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

United Hospital, Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center, Shakopee, Minnesota, United States

Lakeview Hospital, Stillwater, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Rice Memorial Hospital, Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States

Fairview Lakes Medical Center, Wyoming, Minnesota, United States

Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, Missouri, United States

Central Care Cancer Center - Bolivar, Bolivar, Missouri, United States

Cox Cancer Center Branson, Branson, Missouri, United States

Freeman Health System, Joplin, Missouri, United States

Mercy Hospital Joplin, Joplin, Missouri, United States

Lake Regional Hospital, Osage Beach, Missouri, United States

Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States

Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States

Heartland Regional Medical Center, Saint Joseph, Missouri, United States

Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States

Mercy Hospital South, Saint Louis, Missouri, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri, United States

Mercy Hospital Springfield, Springfield, Missouri, United States

CoxHealth South Hospital, Springfield, Missouri, United States

Mercy Hospital Washington, Washington, Missouri, United States

Community Hospital of Anaconda, Anaconda, Montana, United States

Billings Clinic Cancer Center, Billings, Montana, United States

Bozeman Deaconess Hospital, Bozeman, Montana, United States

Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States

Great Falls Clinic, Great Falls, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Community Medical Hospital, Missoula, Montana, United States

Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States

Saint Alphonsus Medical Center-Baker City, Baker City, Oregon, United States

Saint Alphonsus Medical Center-Ontario, Ontario, Oregon, United States

ThedaCare Regional Cancer Center, Appleton, Wisconsin, United States

ThedaCare Cancer Care - Berlin, Berlin, Wisconsin, United States

ThedaCare Regional Medical Center - Neenah, Neenah, Wisconsin, United States

ThedaCare Cancer Care - New London, New London, Wisconsin, United States

Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States

ThedaCare Cancer Care - Oshkosh, Oshkosh, Wisconsin, United States

ThedaCare Cancer Care - Shawano, Shawano, Wisconsin, United States

ThedaCare Cancer Care - Waupaca, Waupaca, Wisconsin, United States

Billings Clinic-Cody, Cody, Wyoming, United States

Welch Cancer Center, Sheridan, Wyoming, United States

Contact Details

Name: Gelareh Sadigh

Affiliation: ECOG-ACRIN Cancer Research Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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