A Feasibility and Acceptability Pilot Study Evaluating a Patient-Specific Targeted Intervention Using Patient Navigators or Routine Clinical Care
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- M.D. Anderson Cancer Center
- Locations
- 2
- Primary Endpoint
- General Self-Efficacy (GSE) Scale Questionnaires
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
General Self-Efficacy (GSE) Scale Questionnaires
Time Frame: through study completion and average of 1 year.
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
Secondary Outcomes
No secondary outcomes reported