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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05488444
• Other study ID #: 2022-0150
• Secondary ID: ASCONCI-2022-064
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 25, 2022
• Est. completion date: October 17, 2023

Study information

• Verified date: October 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 17, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.
• Exit Interview
Participants will be asked to complete an exit interview either in person or by phone

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   MD Anderson Cancer Center