Understanding the Preferences and Views of Older Adults on the Use of Geriatric and Objective Functional Assessments for Cancer Treatment Planning.

Facilitating the Engagement and Satisfaction of Older Adults in Their Cancer Care Planning: a Randomized Study to Understand the Preferences and Views of Older Adults Regarding the Use of Geriatric and Objective Functional Assessments for Cancer Treatment Planning

This Interventional clinical study aims to explore how receiving information about their health and physical abilities affects the treatment decisions of older adults. The study will look at whether sharing detailed assessments of their health and functional status helps older adults better understand their condition and make informed decisions about their care.

The main question it aims to answer is if providing this information changes the treatment priorities of older adults, helping them focus on what matters most to them in their medical care.

Study Overview

• Status: Recruiting
• Conditions: Geriatrics; Geriatric Assessment; Care Delivery
• Intervention / Treatment: Other: Cancer care delivery

Detailed Description

This randomized, interventional, cancer care delivery trial will test whether receipt of Geriatric Assessment (GA) and Objective Functional Status (OFS) assessment data affects older adults' treatment priorities. It will also assess the preferences of older adults for the collection, sharing, and use of their assessment data. Finally, it will explore whether less fit patients experience a lower level of satisfaction and a greater degree of regret with their decision to undergo anti-cancer therapy. This study will utilize a randomized design where participants will be randomized to either the intervention arm (early sharing of GA and OFS results) or to the control arm (delayed sharing of GA and OFS results). To assess patients' preferences for quality vs quantity of life, the investigators will use the Quality Quantity (QQ) questionnaire. All patients will complete this at baseline and then undergo their GA and OFS assessments. Patients randomized to the intervention group will be provided the results of their GA and OFS assessments, and then complete the QQ Questionnaire for a second time to assess for any changes following receipt of their assessment results. Patients randomized to the control group will undergo the assessments and complete the same questionnaire as the intervention group but will not receive the results of their GA and OFS assessments prior to completing the second QQ Questionnaire. For the control group, assessment results will be shared with patients after completion of the follow-up QQ Questionnaire. After reviewing their assessment results, patients in both groups will then complete a questionnaire that inquire about their preferences for receipt, use, and sharing of their assessment data. It will also inquire about the degree to which receipt of these data affected how they experienced their cancer care.

The Investigators will determine whether sharing of geriatric and OFS assessment results affected patients' treatment priorities by measuring the absolute change from baseline in the QQ questionnaire scores for quantity and quality of life, comparing the change in the intervention versus the control group. The Investigators will also describe patients' preferences for the collection, use and sharing of their assessment data as reported in the preferences questionnaire, both overall and by race/ethnicity. To explore differences in patients' satisfaction with their decision to pursue anti-cancer therapy by functional status level, participants will complete the "Was it Worth It" (WIWI) questionnaire at the first of either 1) the conclusion of their treatment regimen or 2) three months after enrollment. The provider assessment will ask whether patients experienced any of the following: a toxicity of treatment ≥grade 3, treatment dose reduction, treatment interruption, treatment discontinuation, hospitalization, or a decline in performance status.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zachary Frosch, MD MSHP; Phone Number: 215-728-2674; Email: Zachary.Frosch@fccc.edu
• Study Contact Backup: Name: Leslie J Fortin, MPH; Phone Number: 215-214-3996; Email: Leslie.Fortin@fccc.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Fox Chase Cancer Center
      • Contact: Leslie J Fortin, MPH; Phone Number: 215-214-3996; Email: Leslie.Fortin@fccc.edu
      • Contact: Gerald T Nkogbu, MBBS, MSc; Phone Number: 215-214-5378; Email: gerald.nkogbu@fccc.edu
      • Contact: Zachary Frosch, MD, MSHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 65

At the time of study screening either:

• Started a new qualifying index regimen within the last 30 days (inclusive)
• Are being considered for a new qualifying index regimen

Exclusion Criteria:

• Patients will be excluded if they

  • Do not have the capacity to consent to study procedures
  • Are unable to complete English language questionnaires
  • Are already using an activity tracker on a daily basis (and therefore may be aware of their current level of activity)
  • Are enrolled in another study in which physical activity is a substantial part or all of the therapeutic intervention or where physical activity is specifically being evaluated and shared with patients. Patients on studies not evaluating or sharing physical activity are eligible for the present study if they meet the other inclusion/exclusion criteria and participation in the present study is not excluded by other studies in which they are enrolled.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Sharing Arm; early sharing of GA and OFS results to participants	Other: Cancer care delivery; Early vs. delayed sharing of GA and OFS diagnostic results and how that sharing affects patient preferences, decision- making, and satisfaction in the context of participants' cancer care.; Other Names: geriatric and OFS assessment; Quality Quantity (QQ) questionnaire; Non-therapeutic
No Intervention: Delayed Sharing Arm; delayed sharing of GA and OFS results to participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in QQ-Length of life from baseline to post-intervention	The QQ uses a 5-point Likert scale to rate each of the 4 questions on the QQ-L subscale. The scores for this subscale are then summed, meaning that patients will receive a score ranging from 4-20 for the QQ-L. The total score from the 4 QQ-L items measures the strength of a participant's preference for length of life, with higher scores meaning greater preference for length of life.	From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary outcome will be the absolute change in the QQ quality of life subscale (QQ-Q) from baseline to post-intervention.	The QQ uses a 5-point Likert scale to rate each of the 4 questions on the QQ-Q subscale. The scores for the subscale are then summed, meaning that patients will receive a score ranging from 4-20 for the QQ-Q. The total score from the 4 QQ-Q items measures the strength of a participant's preference for quality of life, with higher scores meaning greater preference for quality of life.	From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients who, on the Was It Worth It (WIWI) questionnaire, report that their treatment was worthwhile, that they would undergo it again, and that they would recommend it to others.	The proportion of patients who, on the Was It Worth It (WIWI) questionnaire, report that their treatment was worthwhile, that they would undergo it again, and that they would recommend it to others.	From enrollment to the end of treatment or at 3 months after study entry, whichever comes first.
Summary/descriptive statistics for participants' answers to the preferences questionnaire.	It inquires about their preferences for receipt, use and sharing of their assessment results, along with the degree to which receipt of these results affected their understanding or approach to their care	From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Zachary Frosch, MD, MSHP, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; fitness tracking; Care delivery Intervention; Functional Status in Older Adults; Cancer Treatment Preferences; Quality vs Quantity of Life; Patient-Reported Outcomes in Oncology; Quality of Life in Cancer care; Functional Health Assessments; Patient-Centered Cancer Treatment
• Other Study ID Numbers: 24-1020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data will not be shared due to privacy concerns.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No