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

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

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Navigator Phone Calls; Behavioral: Exit Interview

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

I. At least 18 years of age. II. Diagnosis of primary invasive breast cancer. III. Chemotherapy (adjuvant or neo-adjuvant) recommended by treating physician (including pregnant women in 2nd or 3rd trimester).

IV. Patient of the University of Texas MD Anderson Cancer Center or planning on receiving treatment at our Institution.

V. Can speak, read, and understand English and/or Spanish. VI. Participant can provide consent for themself

Exclusion Criteria:

I. Hospitalized for a critical condition or who are considered medically unstable by their medical team.

II. Patients that have been previously treated with chemotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Investigational Group); Participants will complete an in-depth patient needs checklist to identify patient-specific barriers that could lead to a delay with starting chemotherapy.	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
Experimental: Group 2 (Control Group); Participants will follow routine clinical care, where chemotherapy start date is determined by the provider and patient.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Self-Efficacy (GSE) Scale Questionnaires	Responses are made on a 4-point scale, ranging from 1 (not at all true) to 4 (exactly true). Scores could range from a composite score of 10 to 40, with higher score indicating more self-efficacy.25	through study completion and average of 1 year.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Mariana Chavez Mac Gregor, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): October 17, 2023

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-0150; ASCO (Other Grant/Funding Number: FP00004259); NCI-2022-06440 (Other Identifier: NCI-CTRP Clinical Trial Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No