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Transdisciplinary Intervention Integrating Geriatric And Palliative Care With Oncology Care For Older Adults With Cancer

19 november 2021 bijgewerkt door: Ryan Nipp, Massachusetts General Hospital

Pilot Study Of A Transdisciplinary Intervention Integrating Geriatric And Palliative Care With Oncology Care For Older Adults With Cancer

The purpose of this research study is to pilot test a transdisciplinary intervention that integrates both geriatrics and palliative care with routine oncology care for older adults with incurable cancer. The investigators will explore their perceptions of the supportive care needs of older patients with cancer. Using these data, the investigators will finalize the transdisciplinary intervention and perform a pilot, randomized trial of the transdisciplinary intervention versus usual care in patients age ≥65 with newly diagnosed, incurable cancer.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

While evidence suggests that older adults with incurable cancer have unique geriatric and palliative care needs, models of care that are focused on these needs are lacking. The investigators propose to pilot test an intervention targeting the geriatric and palliative care needs of older adults with incurable cancer, referred to as a "transdisciplinary intervention."

The goals of the proposed study are: (1) conduct focus groups with clinicians (from oncology, geriatrics and palliative care) and interviews with patients to explore their perceptions of older patients' supportive care needs and finalize the transdisciplinary intervention; (2) to demonstrate the feasibility and acceptability of delivering the transdisciplinary intervention to older patients with incurable GI and lung cancers; and (3) to estimate the effect size of the transdisciplinary intervention for patient-reported outcomes (e.g., between-group differences from baseline to week 12 in quality of life, physical function, physical and psychological symptoms).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

62

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.

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Massachusetts General Hospital

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 or older
  • Diagnosed with incurable (defined as metastatic or receiving chemotherapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, or lung cancer within the prior 8 weeks (including patients with prior diagnosis of cancer who developed incurable disease)
  • Verbal fluency in English
  • Planning to receive care at Massachusetts General Hospital (MGH)

Exclusion Criteria:

  • Unwilling or unable to participate in the study
  • Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study
  • No medical problems for geriatric clinician to address (e.g. comorbidities, polypharmacy, etc.)

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: Transdisciplinary Intervention

Patients randomized to the Transdisciplinary Intervention will undergo evaluation with a board-certified geriatric clinician, who will tailor their care based on the results of a brief geriatric screening tool.

-Investigators will test a two-visit Transdisciplinary Intervention with the first visit occurring within four weeks of enrollment and the second visit four weeks after the initial visit.
Ander: Transdisciplinary Intervention
Patients randomized to the transdisciplinary intervention will undergo evaluation with a board-certified geriatric clinician, who will tailor their care based on the results of a brief geriatric screening tool, completed prior to their visit. We will test a two-visit transdisciplinary intervention with the first visit occurring within four weeks of enrollment and the second visit four weeks after the initial visit.
Actieve vergelijker: Usual Care
Participants receiving Usual Oncology Care will not meet routinely with geriatric clinicians, though they may receive a geriatrics consult at their request or at the discretion of their treating team.
Ander: Usual Oncology Care
Participants receiving usual oncology care will not meet routinely with geriatric clinicians, though they may receive a geriatrics consult at their request or at the discretion of their treating team.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Perceptions of the necessary components of a transdisciplinary intervention integrating geriatrics and palliative care with oncology care for older patients with incurable GI and lung cancers.
Tijdsspanne: 2 years
We will use qualitative assessment methods to characterize the sample and explore participant perceptions of the supportive care needs of older patients with cancer.
2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rates of study enrollment (proportion of eligible patients who enroll in the study).
Tijdsspanne: 18 Months
To demonstrate feasibility, investigators will calculate rates of study enrollment (proportion of eligible patients who enroll in the study).
18 Months
Rates of study completion (the proportion of participants who complete both study visits).
Tijdsspanne: 18 Months
To demonstrate feasibility, investigators will calculate rates of study completion (the proportion of participants who complete both study visits).
18 Months
Mean change in Quality of Life (measured with the Functional Assessment of Cancer Therapy (FACT) - General) scores between treatment groups from baseline to week 12.
Tijdsspanne: From Baseline to week 12
We will compare mean change in QOL scores between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
From Baseline to week 12
Mean change in symptom scores (measured continuously with the Edmonton Symptom Assessment System-revised (ESAS-r)) between treatment groups from baseline to week 12.
Tijdsspanne: From Baseline to week 12
We will compare mean change in symptom scores between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
From Baseline to week 12
Mean change in depression scores (measured continuously with the Geriatric Depression Scale (GDS)) between treatment groups from baseline to week 12.
Tijdsspanne: From Baseline to week 12
We will compare mean change in depression scores between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
From Baseline to week 12
Rates of post-intervention moderate/severe symptoms (measured as presence or absence of moderate/severe symptoms using the Edmonton Symptom Assessment System-revised (ESAS-r)) between treatment groups.
Tijdsspanne: From Baseline to week 12
We will compare rates of post-intervention moderate/severe symptoms (defined as ESAS scores ≥4) between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
From Baseline to week 12
Rates of post-intervention depression symptoms (measured as presence or absence of depression symptoms using the Geriatric Depression Scale (GDS)) between treatment groups.
Tijdsspanne: From Baseline to week 12
We will compare rates of post-intervention depression symptoms (defined as GDS scores > 5) between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
From Baseline to week 12
Mean change in activities of daily living (measured continuously using a subscale of the Medical Outcomes Study (MOS) Physical Health) between treatment groups from baseline to week 12.
Tijdsspanne: From Baseline to week 12
We will compare mean change in activities of daily living between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
From Baseline to week 12
Mean change in instrumental activities of daily living (subscale of the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)) between treatment groups from baseline to week 12.
Tijdsspanne: From Baseline to week 12
We will compare mean change in instrumental activities of daily living between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
From Baseline to week 12
Mean change in illness perceptions (measured continuously using the Brief Illness Perceptions Questionnaire (BIPQ)) between treatment groups from baseline to week 12.
Tijdsspanne: From Baseline to week 12
We will compare mean change in illness perceptions between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
From Baseline to week 12
Mean change in self-efficacy (measured continuously using the Perceived Efficacy in Patient-Physician Interactions (PEPPI)) between treatment groups from baseline to week 12.
Tijdsspanne: From Baseline to week 12
We will compare mean change in self-efficacy between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
From Baseline to week 12
Rates of post-intervention deficits in activities of daily living (measured as presence or absence of deficits in activities of daily living using a subscale of the Medical Outcomes Study (MOS) Physical Health) between treatment groups.
Tijdsspanne: From Baseline to week 12
We will compare rates of post-intervention deficits in activities of daily living between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
From Baseline to week 12
Rates of post-intervention deficits in instrumental activities of daily living (subscale of the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)) between treatment groups.
Tijdsspanne: From Baseline to week 12
We will compare rates of post-intervention deficits in instrumental activities of daily living between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
From Baseline to week 12
Rates of hospice enrollment prior to death (measured as rates of hospice enrollment prior to death) between treatment groups.
Tijdsspanne: From Baseline until Death, assessed up to 5 years
We will compare rates of hospice enrollment prior to death between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
From Baseline until Death, assessed up to 5 years
Acceptability of the Transdisciplinary Intervention To Older Patients With Incurable GI And Lung Cancers.
Tijdsspanne: 18 Months

Investigators will evaluate acceptability using exit assessment data. Participants will rate their satisfaction with the structure, timing and content of the intervention, using Likert-type scale responses.

Investigators will calculate individual item response frequencies using descriptive statistics to summarize acceptability of different intervention components.
18 Months

Medewerkers en onderzoekers

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

Sponsor

Massachusetts General Hospital

Medewerkers

National Institute on Aging (NIA)

Onderzoekers

  • Hoofdonderzoeker: Ryan Nipp, MD, Massachusetts General Hospital

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

1 oktober 2016

Primaire voltooiing (Werkelijk)

1 oktober 2018

Studie voltooiing (Werkelijk)

20 december 2018

Studieregistratiedata

Eerst ingediend

30 juli 2016

Eerst ingediend dat voldeed aan de QC-criteria

13 augustus 2016

Eerst geplaatst (Schatting)

16 augustus 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 november 2021

Laatste update ingediend die voldeed aan QC-criteria

19 november 2021

Laatst geverifieerd

1 november 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 16-179
  • R03AG053314 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

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

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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