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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-25

Study Completion Date

2023-10-17

Brief Summary

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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

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Detailed Description

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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

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Navigator Phone Calls

Intervention Type BEHAVIORAL

The patient navigator will call you every week as described above in "Study Groups." These phone calls will continue until you begin receiving chemotherapy.

Exit Interview

Intervention Type BEHAVIORAL

Participants will be asked to complete an exit interview either in person or by phone

Group 2 (Control Group)

Participants will follow routine clinical care, where chemotherapy start date is determined by the provider and patient.

Group Type EXPERIMENTAL

Navigator Phone Calls

Intervention Type BEHAVIORAL

The patient navigator will call you every week as described above in "Study Groups." These phone calls will continue until you begin receiving chemotherapy.

Exit Interview

Intervention Type BEHAVIORAL

Participants will be asked to complete an exit interview either in person or by phone

Interventions

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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.

Intervention Type BEHAVIORAL

Exit Interview

Participants will be asked to complete an exit interview either in person or by phone

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes