Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

19 listopada 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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).

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

62

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02114
        • Massachusetts General Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

65 lat i starsze (Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: 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.
Aktywny komparator: 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.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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.
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Rates of study enrollment (proportion of eligible patients who enroll in the study).
Ramy czasowe: 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).
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Massachusetts General Hospital

Współpracownicy

National Institute on Aging (NIA)

Śledczy

  • Główny śledczy: Ryan Nipp, MD, Massachusetts General Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 października 2016

Zakończenie podstawowe (Rzeczywisty)

1 października 2018

Ukończenie studiów (Rzeczywisty)

20 grudnia 2018

Daty rejestracji na studia

Pierwszy przesłany

30 lipca 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 sierpnia 2016

Pierwszy wysłany (Oszacować)

16 sierpnia 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 listopada 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 listopada 2021

Ostatnia weryfikacja

1 listopada 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 16-179
  • R03AG053314 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Nowotwór

Badania kliniczne na Transdisciplinary Intervention

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Nigeria

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj