Clinical trial NCT03721926: A Geriatric Oncology Collaborative Care Intervention for Older Adults With Advanced Cancer
Official title: A Geriatric Oncology Collaborative Care Intervention for Older Adults With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Cancer
Keywords: Other Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-10-26
Enrollment: 91
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of study enrollment
timeFrame: 3 years
Secondary outcomes:
measure: Rates of study completion
timeFrame: 3 years
measure: Change in Quality of Life
timeFrame: 6 Months
measure: Longitudinal effects of the intervention on Quality of Life
timeFrame: 6 months
measure: Change in Symptom Burden
timeFrame: 6 months
measure: Longitudinal effects of the intervention on Symptom Burden
timeFrame: 6 months
measure: Change in depression symptoms
timeFrame: 6 months
measure: Longitudinal effects of the intervention on Depression Symptoms
timeFrame: 6 months
measure: Cange in psychological distress
timeFrame: 6 months
measure: Longitudinal effects of the intervention on psychological distress
timeFrame: 6 months
measure: Change in Activities of Daily Living
timeFrame: 6 months
measure: Longitudinal effects of the intervention on Activities of Daily Living
timeFrame: 6 months
measure: Change in Instrumental Activities of Daily Living
timeFrame: 6 months
measure: Longitudinal effects of the intervention on Instrumental Activities of Daily Living
timeFrame: 6 months
measure: Change in number of falls
timeFrame: 6 months
measure: Longitudinal effects of the intervention on number of falls
timeFrame: 6 months
Other outcomes:
measure: Age as a moderator of the effect of the intervention on quality of life
timeFrame: 6 months
measure: Age as a moderator of the effect of the intervention on symptom burden
timeFrame: 6 months
measure: Age as a moderator of the effect of the intervention on functional outcomes
timeFrame: 6 months
measure: Sex as a moderator of the effect of the intervention on quality of life
timeFrame: 6 months
measure: Sex as a moderator of the effect of the intervention on symptom burden
timeFrame: 6 months
measure: Sex as a moderator of the effect of the intervention on functional outcomes
timeFrame: 6 months
measure: Cancer type as a moderator of the effect of the intervention on quality of life
timeFrame: 6 months
measure: Cancer type as a moderator of the effect of the intervention on symptom burden
timeFrame: 6 months
measure: Cancer type as a moderator of the effect of the intervention on functional outcomes
timeFrame: 6 months
measure: Comorbid conditions as a moderator of the effect of the intervention on quality of life
timeFrame: 6 months
measure: Comorbid conditions as a moderator of the effect of the intervention on symptom burden
timeFrame: 6 months
measure: Comorbid conditions as a moderator of the effect of the intervention on functional outcomes
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan D. Nipp
role: PRINCIPAL_INVESTIGATOR
References: