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

NCT05488444 | Withdrawn Phase 2

• 3 other identifiers: 2022-0150ASCONCI-2022-06440
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group 1 (Investigational Group)

EXPERIMENTAL

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; Behavioral: Exit Interview

Group 2 (Control Group)

EXPERIMENTAL

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

Behavioral: Navigator Phone Calls; Behavioral: Exit Interview

Interventions

Navigator Phone Calls 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.

Group 1 (Investigational Group); Group 2 (Control Group)

Exit Interview BEHAVIORAL

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

Group 1 (Investigational Group); Group 2 (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mariana Chavez Mac Gregor, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: August 25, 2022
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: October 22, 2024

Record last verified: 2023-10

Locations

US (1)