Clinical trial NCT02107443: Improving Communication in Older Cancer Patients and Their Caregivers
Official title: Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Solid Neoplasm
Lymphoma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Patient-Centered Outcomes Research Institute
First posted: 2014-04-08
Enrollment: 546
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Over 60% of cancers occur in older persons, and the number of older persons with cancer is expected to grow as the population ages. Oncology clinical trials have traditionally excluded older patients with advanced cancer and chronic health conditions. In this context, where data is limited and risk from treatment is high, older patients with advanced cancer and their caregivers must understand how cancer treatment can affect quality of life in light of underlying health status. Better communication about age-related health conditions between oncologists, older patients with advanced cancer, and their caregivers may improve decision-making for cancer treatment and quality of life. A geriatric assessment (GA), a validated set of patient-centered outcomes, has been shown to identify concerns (e.g., function, cognition) important to older persons with cancer and their caregivers. In this cluster randomized clinical trial we examined whether providing a web-generated GA summary with targeted recommendations to older patients with advanced cancer, their caregivers, and their oncologists can improve communication about age-related concerns that could affect efficacy and tolerance of cancer treatment. We also determined whether the intervention improves patient-reported quality of life and patient and caregiver satisfaction.

Detailed description: OBJECTIVES:

I. Primary Aim - Direct Communication about Age-related Concerns: 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. \[Patient-Centered Outcomes Research Institute (PCORI) specified\]

II. Primary Aim - Patient Satisfaction with Communication about Age-related Concerns: 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. \[National Cancer Institute (NCI) specified\]

III. Secondary Aim - 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.

IV. Secondary Aim - 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.

OUTLINE: Patients are randomized to 1 of 2 arms.

Arm I: At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA and receive the GA summary plus GA targeted recommendations which is provided to the oncology team to discuss and implement if they so choose.

Arm II: At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA (no GA summary or recommendations are provided).

Patients are followed at 4-6 weeks, 3 months, and 6 months. Survival data will be collected at 1 year after enrollment.

Eligibility criteria: Inclusion Criteria for Patients

* Male or female 70 years of age or older
* 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.

Exclusion Criteria for Patients

* 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).

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.
* 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 for Caregivers

-Caregivers unable to understand the consent form due to cognitive, health, or sensory impairment will be excluded.

Primary outcomes:
measure: Direct Communication About Age-related Concerns: Number of Discussions Related to the Geriatric Assessment That Occur in the Clinic Visit Between the Patient, Oncology Physician, and Caregiver. [Patient-Centered Outcomes Research Institute Specified]
timeFrame: Baseline
measure: Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified]
timeFrame: Within 1-7 days of the baseline audio-recorded clinic consultation
Secondary outcomes:
measure: Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Quality of Life of Older Patients Receiving Treatment and Their Caregivers.
timeFrame: Mean score over 4-6 weeks, 3 months, 6 months assessments following the intervention
measure: Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Caregiver Satisfaction With Communication About Age-related Issues.
timeFrame: At 4-6 weeks, 3 months and 6 months following the intervention
measure: Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Quality of Life of Older Patients Receiving Treatment and Their Caregivers.
timeFrame: Mean 4-6 weeks, 3 months, and 6 months after the intervention
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Newark
country: United States
facility: Delaware/Christiana Care NCORP
state: Delaware
city: Honolulu
country: United States
facility: Hawaii
state: Hawaii
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
city: Decatur
country: United States
facility: Heartland NCORP
state: Illinois
city: Prairie Village
country: United States
facility: Kansas City NCORP
state: Kansas
city: Wichita
country: United States
facility: Wichita NCORP
state: Kansas
city: Ann Arbor
country: United States
facility: Michigan Cancer Research Consortium
state: Michigan
city: Minneapolis
country: United States
facility: Metro-Minnesota NCORP
state: Minnesota
city: Las Vegas
country: United States
facility: Nevada NCORP
state: Nevada
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Winston-Salem
country: United States
facility: Southeast Clinical Oncology Research Consortium
state: North Carolina
city: Columbus
country: United States
facility: Columbus NCORP
state: Ohio
city: Portland
country: United States
facility: Pacific Cancer Research Consortium Ncorp
state: Oregon
city: Danville
country: United States
facility: Geisinger Cancer Institute NCORP
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville NCORP
state: South Carolina
city: Marshfield
country: United States
facility: WiNCORP
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora NCORP
state: Wisconsin
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Supriya Mohile
role: PRINCIPAL_INVESTIGATOR
References:
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