Back to results

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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Experimental

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Discussion Prioritization Tool (DPT)

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

Functional Assessment of the Discussion Prioritization Tool (DPT)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05073432

First Posted

September 28, 2021

Last Updated

July 17, 2023

Sponsor

University of Rochester

1. Study Identification

Unique Protocol Identification Number

NCT05073432

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

July 28, 2021 (Actual)

Primary Completion Date

March 15, 2023 (Actual)

Study Completion Date

March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Discussion Prioritization Tool (DPT)

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Experimental

Intervention Description

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

Primary Outcome Measure Information:

Title

Functional Assessment of the Discussion Prioritization Tool (DPT)

Description

Time Frame

2 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allison Magnuson, DO

Organizational Affiliation

Univ. of Rochester Wilmot Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs