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Trial Title:
Understanding the Preferences and Views of Older Adults on the Use of Geriatric and Objective Functional Assessments for Cancer Treatment Planning.
NCT ID:
NCT06652347
Condition:
Care Delivery
Geriatrics
Geriatric Assessment
Conditions: 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
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Cancer care delivery
Description:
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.
Arm group label:
Early Sharing Arm
Other name:
geriatric and OFS assessment
Other name:
Quality Quantity (QQ) questionnaire
Other name:
Non-therapeutic
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.
Criteria for 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)
- 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.
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Contact:
Last name:
Leslie J Fortin, MPH
Phone:
215-214-3996
Email:
Leslie.Fortin@fccc.edu
Contact backup:
Last name:
Gerald T Nkogbu, MBBS, MSc
Phone:
215-214-5378
Email:
gerald.nkogbu@fccc.edu
Contact backup:
Last name:
Zachary Frosch, MD, MSHP
Start date:
November 2024
Completion date:
November 2026
Lead sponsor:
Agency:
Fox Chase Cancer Center
Agency class:
Other
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Fox Chase Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06652347
