Clinical trial NCT05488444: A Feasibility and Acceptability Pilot Study Evaluating a Patient-Specific Targeted Intervention Using Patient Navigators or Routine Clinical Care
Official title: A Feasibility and Acceptability Pilot Study Evaluating a Patient-Specific Targeted Intervention Using Patient Navigators or Routine Clinical Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: General Self-Efficacy (GSE) Scale Questionnaires
timeFrame: through study completion and average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Mariana Chavez Mac Gregor, MD
role: PRINCIPAL_INVESTIGATOR
References: