Development of a Personalized Discussion Prioritization Tool for Older Adults Considering Adjuvant Chemotherapy for Breast Cancer

Sponsor

University of Rochester (Other)

Overall Status

Recruiting

CT.gov ID

NCT05073432

Collaborator

(none)

Enrollment

Location

Arm

22.1

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators have developed a Discussion Prioritization Tool (DPT) for older adults consider adjuvant chemotherapy that utilizes Conjoint Analysis (CA) methodology and the objective of the current study is to assess usability of this DPT in the target population, older adults with breast cancer and to adapt the tool to optimize usability for the target population.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Experimental	Phase 1

Detailed Description

Given the complexity of adjuvant chemotherapy decision making for older adults with breast cancer, enhancing support and promoting treatment discussions in the context of patient's goals and preferences is an important need. With this need in mind, the investigators have completed interviews with patients with cancer patients who are considering adjuvant therapy. As a result of these interviews, the investigators have developed a common list of attributes (variables found to be important in decision making) that were used to create the Discussion Prioritization Tool (DPT) using Conjoint Analysis (CA) methodology. CA which is a method that can assess the relative importance that patients place on different aspects of care by asking patients to make a series of trade-offs between competing options. The purpose of this study is to assess the usability of a Discussion Prioritization Tool, administered through a tablet, laptop, or computer, for its ability to aid in treatment decision-making. The investigators would like to gather feedback from individuals to improve and adapt the communication tool.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Study in Development of a Personalized Discussion Prioritization Tool for Older Adults Considering Adjuvant Chemotherapy for Breast Cancer

Actual Study Start Date :

Jul 28, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Electronic completion of Geriatric Assessment and Conjoint Analysis with result output.	Other: Experimental Usability of the Discussion Prioritization Tool (DPT) by completing Geriatric Assessment and Conjoint Analysis

Arm

Intervention/Treatment

Experimental: Experimental

Electronic completion of Geriatric Assessment and Conjoint Analysis with result output.

Other: Experimental

Usability of the Discussion Prioritization Tool (DPT) by completing Geriatric Assessment and Conjoint Analysis

Outcome Measures

Primary Outcome Measures

Functional Assessment of the Discussion Prioritization Tool (DPT) [2 Months]
System Usability Scale (SUS) (score on 10-item scale, total score ranging 0-100; higher score corresponds to greater usability). We will deem the tool usable if our mean SUS score among the 10 patients enrolled is >68.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥65
Diagnosis of stage I-III BC
Being considered for adjuvant chemotherapy
Able to speak and read English
Able to participate in study procedures.

Exclusion Criteria:

Lacking medical decision-making capacity as determined by their oncologist
Evidence of metastatic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator: Allison Magnuson, DO, Univ. of Rochester Wilmot Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Allison Magnuson, Assistant Professor - Department of Medicine , Hematology/Oncology (SMD), University of Rochester

ClinicalTrials.gov Identifier:

NCT05073432

Other Study ID Numbers:

UCCS20110

First Posted:

Oct 11, 2021

Last Update Posted:

Jul 12, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Allison Magnuson, Assistant Professor - Department of Medicine , Hematology/Oncology (SMD), University of Rochester

Breast Cancer

Discussion Prioritization Tool (DPT)

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jul 12, 2022