Improving Communication in Older Cancer Patients and Their Caregivers
Conditions
Adult Solid Neoplasm - Lymphoma
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Intervention
Name: Informational Intervention Type: Other
Name: Questionnaire Administration Type: Other
Name: Quality-of-Life Assessment Type: Other
Overall Status
Recruiting
Summary
This randomized clinical trial studies standardized geriatric assessment (GA) or usual care in improving communication and quality of life in older patients with advanced solid tumors or lymphoma and their caregivers. A GA measures the issues important to older patients, including function, psychological status, cognitive abilities, social support, and the impact of medical problems on quality of life. A GA may improve communication between patients and their doctors in addressing patient concerns. It is not yet known whether a standardized GA is more effective than usual care in improving communication and quality of life in older patients with solid tumors or lymphoma.
Detailed Description
PRIMARY OBJECTIVES:

I. To determine if providing geriatric assessment (GA) summary plus GA-driven recommendations to patients, their caregivers and oncology physicians improves patient satisfaction with communication with the oncology physician regarding age-related concerns.

SECONDARY OBJECTIVES:

I. To determine if providing GA summary plus GA-driven recommendations to patients, their caregivers, and oncology physicians increases discussions about age-related issues during clinic consultation.

II. To determine whether initially providing patients, their caregivers, and oncology physicians with GA summary plus GA-driven recommendations prior to their treatment influences quality of life of older patients receiving treatment and their caregivers.

III. To determine whether providing patients, their caregivers, and oncology physicians with GA summary plus GA-driven recommendations influences caregiver satisfaction with communication about age-related issues.

TERTIARY OBJECTIVES:

I. Evaluate whether the number of discussions about age-related issues during the clinic visit correlates with patient satisfaction and will explore if communication about age-related issues influences how patients, caregivers, and oncology physicians make decisions for cancer treatment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients and their caregivers (if participating) complete the GA summary and receive recommendations guided by GA results provided by the oncology team to discuss and implement for each age-related issue at baseline.

ARM II: Patients and their caregivers (if participating) complete the GA at baseline.

After completion of study, patients are followed up at 4-6 weeks, 10-14 weeks, and 20-24 weeks.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 70 Years
Gender: Both
Criteria: Inclusion Criteria:

- Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; a patient with a diagnosis of stage III cancer or lymphoma is eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed

- Must be considering or currently receiving any kind of cancer treatment (any line), including but not limited to hormonal treatment, chemotherapy, monoclonal antibody therapy, or targeted therapy; patients who are considering therapy are eligible even if they ultimately choose not to be on therapy; patients with a history of any previous cancer treatment, including radiation and/or surgery are eligible; a patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met

- Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy

- Have visits planned with the oncology physician for at least 3 months and be willing to come in for study visits

- Able to provide informed consent or, if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (per institutional policies) must sign consent by the baseline visit

- Subject has adequate understanding of the English language because not all GA measures have been validated in other languages

- Entry criteria for caregivers: a caregiver can be anyone age 21 or over who is able to understand spoken English and understand the study process and provide informed consent; one caregiver for each patient will be eligible and must be chosen by the patient; for the purposes of this study, a caregiver is defined as a valued and trusted person in a patient's life who is supportive in health care matters by providing valuable social support and/or direct assistive care; the caregiver accompanies the patient to medical appointments, is able to listen and give thoughtful advice and may be a family member, partner, friend, or professional caregiver

- INCLUSION CRITERIA FOR CAREGIVERS: selected by the patient when asked if there is a "family member, partner, friend or caregiver (age 21 or older) with whom you discuss or who can be helpful in health-related matters"; patients who cannot identify such a person ("caregiver") can be eligible for the study; a caregiver need not be someone who lives with the patient or provides direct hands-on care; a caregiver can be any person who provides support (in any way) to the patient

- INCLUSION CRITERIA FOR CAREGIVERS: if a health care proxy signs consent for or with a patient, and wants to participate in the caregiver portion of the study, this same person will always be the caregiver selected; if a health care proxy does not want to enroll as a caregiver in the study or, if enrolled, chooses to stop their own participation in the caregiver portion of the study, but is able to assist the patient in completing the study, the patient can still participate; in other words, the health care proxy can choose NOT to participate in the caregiver portion of the study; this does not preclude the patient from participating in the patient portion of the study with the health care proxy's assistance

Exclusion Criteria:

- Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible

- Have already made a decision to not undergo any cancer treatment (e.g., being followed in best supportive care or hospice)

- EXCLUSION CRITERIA FOR CAREGIVERS: caregivers unable to understand the consent form due to cognitive, health, or sensory impairment will be excluded
Locations
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Status: Active, not recruiting
Delaware/Christiana Care NCORP
Newark, Delaware, United States
Status: Recruiting
Contact: Kandie Dempsey - 302-623-4518 - kdempsey@christianacare.org
Hawaii MU-NCORP
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Virginia McMahon - 808-586-2979
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Status: Not yet recruiting
Contact: William Dale - 773-834-0508 - wdale@medicine.bsd.uchicago.edu
Heartland NCORP
Decatur, Illinois, United States
Status: Recruiting
Contact: Peggy Wisher - 217-876-4755 - pwisher@dmhhs.org
Kansas City NCORP
Prairie Village, Kansas, United States
Status: Recruiting
Contact: Leslie Herst - 913-948-5588 - lherst@kccop.org
Wichita NCORP
Wichita, Kansas, United States
Status: Recruiting
Contact: Keisha Humphries - 316-268-5784 - keisha.humphries@viachristi.org
Metro-Minnesota NCORP
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Michelle Lacey, RN - 952-993-1517 - michele.lacey@parknicollet.com
Nevada NCORP
Las Vegas, Nevada, United States
Status: Recruiting
Contact: Karen Sartell - 702-384-0013 - k.sartell@sncrf.org
University of Rochester
Rochester, New York, United States
Status: Not yet recruiting
Contact: Supriya G. Mohile - 585-275-5513 - supriya_mohile@urmc.rochester.edu
Southeast Clinical ONcology Research Consortium
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: Robin Burgess, RN - 336-777-3036 - rburgess@southeastclinicaloncology.org
Southeast Clinical Oncology Research Consortium
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: Judith O. Hopkins - 336-277-8887 - johopkins@novanthealth.org
Columbus NCORP
Columbus, Ohio, United States
Status: Recruiting
Contact: Julie O'Brien - 614-488-3320 - julie@columbusccop.org
Dayton NCORP
Dayton, Ohio, United States
Status: Recruiting
Contact: Mary Ontko, RN - 937-775-1360 - mary.ontko@wright.edu
Greenville NCORP
Greenville, South Carolina, United States
Status: Recruiting
Contact: Lyndon Evans, RN - 864-404-2045 - Levans4@ghs.org
Start Date
June 2014
Completion Date
August 2019
Sponsors
Gary Morrow
Source
University of Rochester
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page