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

NCT03721926 | Completed

• 2 other identifiers: 18-389K12CA087723
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Cancer

Keywords

Other Cancer

Outcome Measures

Primary Outcomes (1)

• Rates of study enrollment

  To demonstrate feasibility, investigators will calculate rates of study enrollment (proportion of eligible patients who enroll in the study).

  3 years

Secondary Outcomes (15)

• Rates of study completion

  3 years

• Change in Quality of Life

  6 Months

• Longitudinal effects of the intervention on Quality of Life

  6 months

• Change in Symptom Burden

  6 months

• Longitudinal effects of the intervention on Symptom Burden

  6 months

Other Outcomes (12)

• Age as a moderator of the effect of the intervention on quality of life

  6 months

• Age as a moderator of the effect of the intervention on symptom burden

  6 months

• Age as a moderator of the effect of the intervention on functional outcomes

  6 months

Study Arms (2)

Geriatric Oncology Collaborative Care

EXPERIMENTAL

Patients 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.

Other: Geriatric Oncology Collaborative Care

Usual Care

ACTIVE COMPARATOR

Participants 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.

Other: Usual Care

Interventions

Usual Care OTHER

Participants 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.

Usual Care

Geriatric Oncology Collaborative Care OTHER

Patients 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.

Geriatric Oncology Collaborative Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Uncontrolled psychiatric illness or impaired cognition

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02214, United States

Location

Study Officials

• Ryan D. Nipp

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 26, 2018
• Study Start: February 14, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)