Clinical Trials Directory

Trials / Completed

CompletedNCT03721926

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
91 (actual)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERUsual CareParticipants assigned to receive usual oncology care will not meet with the study nurses, though they may receive geriatric or palliative care consults at their request or at the discretion of their treating oncologist.
OTHERGeriatric Oncology Collaborative CarePatients receive three visits with a trained study nurse. At each visit, the study nurse will assess the patient's symptom burden, functional status, comorbid conditions, psychosocial issues, and medication use. The nurses can refer patients to specialists as needed. The study nurses will meet with a supervising support team, consisting of clinicians from geriatrics, palliative care, social work, and pharmacy to discuss each patient and review documentation. Following the team meetings, the nurses will document recommendations in the medical record and communicate with the primary oncology team, either in person or via phone, as appropriate. The study nurses will contact the supervising team in between meetings for any urgent issues or questions that arise.

Timeline

Start date
2019-02-14
Primary completion
2022-03-31
Completion
2022-03-31
First posted
2018-10-26
Last updated
2022-04-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03721926. Inclusion in this directory is not an endorsement.