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Inzicht in de voorkeuren en opvattingen van oudere volwassenen over het gebruik van geriatrische en objectieve functionele beoordelingen voor de planning van de behandeling van kanker.

16 september 2026 bijgewerkt door: Zachary Frosch, Fox Chase Cancer Center

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.

Studie Overzicht

Toestand

Werving

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19111
        • Werving
        • Fox Chase Cancer Center
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Zachary Frosch, MD, MSHP

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Early Sharing Arm

early sharing of GA and OFS results to participants

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.

Andere namen:
  • geriatrische en OFS-beoordeling
  • Vragenlijst Kwaliteit Kwantiteit (QQ).
  • Niet-therapeutisch
Geen tussenkomst: Delayed Sharing Arm

delayed sharing of GA and OFS results to participants

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Absolute change in QQ-Length of life from baseline to post-intervention
Tijdsspanne: 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.

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

Secundaire uitkomstmaten

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

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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: From enrollment to the end of treatment or at 3 months after study entry, whichever comes first.

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

It inquires about their preferences for receipt, use and sharing of their assessment results, along with the degree to which receipt of these results affected their understanding or approach to their care

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Zachary Frosch, MD, MSHP, Fox Chase Cancer Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 februari 2025

Primaire voltooiing (Geschat)

1 maart 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

15 oktober 2024

Eerst ingediend dat voldeed aan de QC-criteria

21 oktober 2024

Eerst geplaatst (Werkelijk)

22 oktober 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 september 2026

Laatste update ingediend die voldeed aan QC-criteria

16 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual Participant Data will not be shared due to privacy concerns.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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