Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652347
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Understanding the Preferences and Views of Older Adults on the Use of Geriatric and Objective Functional Assessments for Cancer Treatment Planning
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 raceethnicity 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
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 raceethnicity 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None