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

NCT06652347 | Recruiting

• 1 other identifier: 24-1020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Care Delivery; Geriatrics; Geriatric Assessment

Keywords

fitness tracking; Care delivery Intervention; Functional Status in Older Adults; Cancer Treatment Preferences; Quality vs Quantity of Life; Patient-Reported Outcomes in Oncology; Randomized Controlled Trial; Quality of Life in Cancer care; Functional Health Assessments; Patient-Centered Cancer Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary outcome will be the absolute change in the QQ quality of life subscale (QQ-Q) from baseline to post-intervention.

  From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.

Other Outcomes (2)

• 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.

  From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.

Study Arms (2)

Early Sharing Arm

EXPERIMENTAL

early sharing of GA and OFS results to participants

Other: Cancer care delivery

Delayed Sharing Arm

NO INTERVENTION

delayed sharing of GA and OFS results to participants

Interventions

Cancer care delivery 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.

Also known as: geriatric and OFS assessment, Quality Quantity (QQ) questionnaire, Non-therapeutic

Early Sharing Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

MeSH Terms

Interventions

Aging; Surveys and Questionnaires; Body Modification, Non-Therapeutic

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative

Study Officials

• Zachary Frosch, MD, MSHP

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary Frosch, MD MSHP

CONTACT

215-728-2674; Zachary.Frosch@fccc.edu

Leslie J Fortin, MPH

CONTACT

215-214-3996; Leslie.Fortin@fccc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Hematology/Oncology

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 22, 2024
• Study Start: February 21, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)