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

NCT ID: NCT02868112

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-20

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Cancer

Keywords

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Cancer Care Palliative Care Geriatrics Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Transdisciplinary Intervention

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Usual Oncology Care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ryan Nipp

Clinical Director of Thoracic Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan Nipp, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts general Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R03AG053314

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-179

Identifier Type: -

Identifier Source: org_study_id