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

NCT ID: NCT06652347

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-21
• Study Completion Date: 2026-11-30

Brief Summary

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.

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.

Conditions

Care Delivery; Geriatrics; Geriatric Assessment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Early Sharing Arm

early sharing of GA and OFS results to participants

Group Type: EXPERIMENTAL

Cancer care delivery

Intervention Type: OTHER

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.

Delayed Sharing Arm

delayed sharing of GA and OFS results to participants

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

geriatric and OFS assessment; Quality Quantity (QQ) questionnaire; Non-therapeutic

Eligibility Criteria

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Zachary Frosch

Assistant Professor Department of Hematology/Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zachary Frosch, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zachary Frosch, MD MSHP

Role: CONTACT

Zachary.Frosch@fccc.edu

215-728-2674

Leslie J Fortin, MPH

Role: CONTACT

Leslie.Fortin@fccc.edu

215-214-3996

Facility Contacts

Leslie J Fortin, MPH

Role: primary

Leslie.Fortin@fccc.edu

215-214-3996

Gerald T Nkogbu, MBBS, MSc

Role: backup

gerald.nkogbu@fccc.edu

215-214-5378

Other Identifiers

24-1020

Identifier Type: -

Identifier Source: org_study_id