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)
10
Enrollment
1
Location
1
Arm
10.1
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We 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 our target population, older adults with breast cancer and to adapt the tool to optimize usability for our target population.

Condition or DiseaseIntervention/TreatmentPhase
  • 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, our group has completed interviews with patients with cancer patients who are considering adjuvant therapy. As a result of these interviews, our group has 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. We 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, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

ArmIntervention/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

  1. 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:
No
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

SiteCityStateCountryPostal Code
1University of RochesterRochesterNew YorkUnited States14642

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:
Oct 11, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Allison Magnuson, Assistant Professor - Department of Medicine , Hematology/Oncology (SMD), University of Rochester
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021