Care DeliveryNCT06652347
Understanding the Preferences and Views of Older Adults on the Use of Geriatric and Objective Functional Assessments for Cancer Treatment Planning.
A study testing Cancer care delivery in people with Care Delivery and Geriatrics, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Care Delivery, Geriatrics, Geriatric Assessment
- What is being tested?
- Cancer care delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Leslie J Fortin, MPH, 215-214-3996, Leslie.Fortin@fccc.edu
Gerald T Nkogbu, MBBS, MSc, 215-214-5378, gerald.nkogbu@fccc.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Cancer care delivery
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer care deliveryOther
Also called geriatric and OFS assessment, Quality Quantity (QQ) questionnaire, Non-therapeutic
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Sharing Arm | Experimental | early sharing of GA and OFS results to participants Receives: Other: Cancer care delivery |
| Delayed Sharing Arm | No intervention | delayed sharing of GA and OFS results to participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start21 Feb 2025
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care DeliveryStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Zachary Frosch, Fox Chase Cancer Center
- Investigators
- Zachary Frosch, MD, MSHP, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652347
- Sponsor's protocol ID
- 24-1020
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared due to privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06652347
- Acronym / sponsor ID
- 24-1020
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Sharing Arm | Experimental | Other: Cancer care deliveryearly sharing of GA and OFS results to participants |
| Delayed Sharing Arm | No intervention | –delayed sharing of GA and OFS results to participants |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 65
- Started a new qualifying index regimen within the last 30 days (inclusive)
- Are being considered for a new qualifying index regimen
Key exclusion criteria (5 listed)
- Patients will be excluded if they
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer care deliveryAlso: geriatric and OFS assessment, Quality Quantity (QQ) questionnaire, Non-therapeuticEarly 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 | Early Sharing Arm |
Primary outcome
Absolute change in QQ-Length of life from baseline to post-intervention
Time frame: From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
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.
1 secondary outcome
The secondary outcome will be the absolute change in the QQ quality of life subscale (QQ-Q) from baseline to post-intervention.
Time frame: From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared due to privacy concerns.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zachary Frosch, MD, MSHP principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer care delivery in people with Care Delivery and Geriatrics, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zachary Frosch, MD MSHP (215-728-2674, Zachary.Frosch@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in QQ-Length of life from baseline to post-intervention (time frame: From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.