A Geriatric Oncology Collaborative Care Intervention for Older Adults With Advanced Cancer

Not Applicable

Completed

• Conditions: Other Cancer

• Registration Number: NCT03721926
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this research study is to develop a geriatric oncology collaborative care intervention to enhance the quality of life, symptom burden, and functional outcomes of older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancers.

Detailed Description

Cancer disproportionately affects older adults, and the number of older adults with cancer is expected to grow as the population ages. Older adults with advanced cancer often possess a distinct set of medical and psycho-social issues that makes caring for the geriatric oncology population challenging for oncologists. Currently, a critical knowledge gap exists regarding how best to deliver comprehensive cancer care targeting the unique geriatric and palliative care needs of these individuals. The investigators propose to develop a geriatric oncology collaborative care intervention to improve supportive care outcomes for older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancer. GI and GU cancers are among the leading causes of cancer death in the geriatric cancer population, and patients with advanced GI and GU cancers experience a high symptom burden. The intervention will entail visits with an oncology advanced practice nurse trained to address patients' unique needs, who will meet regularly with a supervising team of geriatric, palliative care, social work, and pharmacy clinicians for feedback and iterative reevaluation of the care plan. Using nurses who are already integrated into the oncology setting represents a scalable model that addresses the workforce shortage of geriatric and palliative care clinicians. The investigators used conceptual models for collaborative care and geriatric interventions to develop an initial intervention framework, and prior research to develop a preliminary intervention manual. In Aim 1, the investigators will refine and finalize both the intervention and the intervention manual based on qualitative data from patients, caregivers, and clinicians to ensure the intervention targets the unique needs of older adults with advanced cancer. In Aim 2, the investigators will modify the intervention and study methods with an open pilot study (n=10). In Aim 3, the investigators will conduct a pilot randomized trial (n=75) to assess the feasibility and preliminary efficacy of the geriatric oncology collaborative care intervention for improving patients' QOL, symptom burden, and functional outcomes.

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-26
• Study Start: 2019-02-14
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Age 65 or older
• Diagnosed with advanced (defined as metastatic or receiving therapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, renal, bladder, or prostate cancer within the past 8 weeks (includes patients with a new diagnosis, progression or recurrence).
• ECOG performance status of 0-2
• Ability to read and respond to questions in English
• Planning to receive care at MGH

Exclusion Criteria

• Uncontrolled psychiatric illness or impaired cognition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rates of study enrollment	3 years	To demonstrate feasibility, investigators will calculate rates of study enrollment (proportion of eligible patients who enroll in the study).

Secondary Outcome Measures

Name	Time	Method
Longitudinal effects of the intervention on Depression Symptoms	6 months	To determine longitudinal effects of the intervention on depression symptoms (measured with the Geriatric Depression Scale (GDS)), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in depression symptoms across multiple time points (e.g. baseline, four months, and six months).
Change in Activities of Daily Living	6 months	Compare change in Activities of Daily Living (measured with the Medical Outcomes Study) between treatment groups from baseline to 4 and 6 months.
Change in number of falls	6 months	Compare change in number of falls in the past 6 months between treatment groups from baseline to 4 and 6 months.
Rates of study completion	3 years	To demonstrate feasibility, investigators will calculate rates of study completion (the proportion of participants who complete all study outcome assessments).
Change in depression symptoms	6 months	Compare change in depression symptoms (measured with the 15-item Geriatric Depression Scale (GDS) with higher scores indicating greater depressive symptoms) between treatment groups from baseline to 4 and 6 months.
Cange in psychological distress	6 months	Compare change in psychological distress (measured with the PHQ-4) between treatment groups from baseline to 4 and 6 months.
Longitudinal effects of the intervention on Activities of Daily Living	6 months	To determine longitudinal effects of the intervention on Activities of Daily Living (measured with the Medical Outcomes Study), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in Activities of Daily Living across multiple time points (e.g. baseline, four months, and six months).
Change in Instrumental Activities of Daily Living	6 months	Compare change in Instrumental Activities of Daily Living (measured with the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)) between treatment groups from baseline to 4 and 6 months.
Longitudinal effects of the intervention on Instrumental Activities of Daily Living	6 months	To determine longitudinal effects of the intervention on Instrumental Activities of Daily Living (measured with the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in Instrumental Activities of Daily Living across multiple time points (e.g. baseline, four months, and six months).
Change in Quality of Life	6 Months	Compare change in QOL (measured with the Functional Assessment of Cancer Therapy (FACT) - General) between treatment groups from baseline to 4 and 6 months.
Change in Symptom Burden	6 months	Compare change in symptom burden Burden (measured with the Edmonton Symptom Assessment System-revised (ESAS-r)) between treatment groups from baseline to 4 and 6 months.
Longitudinal effects of the intervention on Quality of Life	6 months	To determine longitudinal effects of the intervention on QOL (measured with the Functional Assessment of Cancer Therapy (FACT) - General), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in QOL across multiple time points (e.g. baseline, four months, and six months).
Longitudinal effects of the intervention on Symptom Burden	6 months	To determine longitudinal effects of the intervention on symptom burden (measured with the Edmonton Symptom Assessment System-revised (ESAS-r)), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in symptom burden across multiple time points (e.g. baseline, four months, and six months).
Longitudinal effects of the intervention on psychological distress	6 months	To determine longitudinal effects of the intervention on psychological distress (measured with the PHQ-4), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in psychological distress across multiple time points (e.g. baseline, four months, and six months).
Longitudinal effects of the intervention on number of falls	6 months	To determine longitudinal effects of the intervention on number of falls in the past 6 months, investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in number of falls in the past 6 months across multiple time points (e.g. baseline, four months, and six months).

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States