NCT05488444

A Feasibility and Acceptability Pilot Study Evaluating a Patient-Specific Targeted Intervention Using Patient Navigators or Routine Clinical Care

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Project Lets start will provide individual support to breast cancer patients with the goal of reducing delay to chemotherapy initiation. In this study participants will identify areas of need and work with patient navigators who will provide weekly 1-1 support throughout patient's journey to beginning chemotherapy

Detailed description

OBJECTIVES: Among patients with early-stage breast cancer, delays with the administration of chemotherapy significantly reduce its benefit. Interventions aimed at reducing TTC have the potential of improving outcomes and reducing health disparities. In this study we propose to develop an effective targeted intervention that is culturally sensitive and that addresses the roots of chemotherapy delay. Our objective is to conduct a pilot study randomizing patients with breast cancer, in whom adjuvant or neoadjuvant chemotherapy has been recommended, to a culturally sensitive and patient-specific targeted intervention using patient navigators or routine clinical care Primary Aim: To establish feasibility and acceptability. We hypothesize that the intervention will be feasible and accepted by participants. Secondary Aim: Explore TTC according to treatment arm. We hypothesize that the TTC will be shorter among participants randomized to the intervention Exploratory Aim: 1) To determine if social support, interpersonal trust in a physician, and general self-efficacy changed from baseline to the end of the intervention; and 2) to determine if that change was similar between participants randomized to the intervention compared to the control arm. We hypothesize that there will be favorable changes in scores among participants randomized to the intervention, while no change will occur among those randomized to the control arm.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Navigator Phone Calls	The patient navigator will call you every week as described above in "Study Groups." These phone calls will continue until you begin receiving chemotherapy.
BEHAVIORAL	Exit Interview	Participants will be asked to complete an exit interview either in person or by phone

Timeline

• Start date: 2022-08-25
• Primary completion: 2023-10-17
• Completion: 2023-10-17
• First posted: 2022-08-04
• Last updated: 2024-10-22

Locations

1 site across 1 country: United States