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Improving Communication in Older Cancer Patients and Their Caregivers (COACH)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02107443
First Posted: April 8, 2014
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base
  Purpose
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.

Condition Intervention Phase
Adult Solid Neoplasm Lymphoma Other: Informational Intervention Other: Questionnaire Administration Other: Quality-of-Life Assessment Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers

Resource links provided by NLM:


Further study details as provided by Gary Morrow, University of Rochester NCORP Research Base:

Primary Outcome Measures:
  • Patient satisfaction with communication regarding age-related issues as measured by Health Care Climate Questionnaire (HCCQ) [ Time Frame: Within 1-7 days of the baseline audio-recorded clinic consultation ]
    Will apply linear mixed model methodology. The total HCCQ scores will be the response, and the arm will be the fixed effect. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using the Kenward-Roger small sample procedure. 95% credible ("confidence") interval will also be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each site.


Secondary Outcome Measures:
  • Number of discussions related to different aspects of geriatric assessment that occur in the consultation clinic visit between the patient, oncology physician, and caregiver [ Time Frame: Baseline ]
    Will apply linear mixed model methodology. The total HCCQ scores will be the response, and the arm will be the fixed effect. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using the Kenward-Roger small sample procedure. 95% credible ("confidence") interval will also be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using BLUP of the mean response for each site.

  • Proportion of oncology physicians who initiate any discussion related to the patient's age-related issues [ Time Frame: Up to 20-24 weeks ]
  • Percentage of time an oncology physician responds appropriately to an older patient or caregiver-initiated discussion on age-related needs and concerns [ Time Frame: Up to 20-24 weeks ]
  • Health-related quality of life (HRQoL) assessed with the Functional Assessment of Cancer Therapy (FACT) [ Time Frame: At 4-6 weeks following the intervention ]
    Will apply linear mixed model methodology. The total HCCQ scores will be the response, and the arm will be the fixed effect. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using the Kenward-Roger small sample procedure. 95% credible ("confidence") interval will also be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using BLUP of the mean response for each site.

  • Caregiver HRQoL as assessed with the Caregiver Reactions Assessment (CRA) and the modified health care climate questionnaire for the caregiver [ Time Frame: At 4-6 weeks following the intervention ]
    Will apply linear mixed model methodology. The total HCCQ scores will be the response, and the arm will be the fixed effect. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using the Kenward-Roger small sample procedure. 95% credible ("confidence") interval will also be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using BLUP of the mean response for each site.

  • Caregiver satisfaction with communication (as measured by the modified HCCQ) [ Time Frame: At 4-6 weeks following the intervention ]
    The linear mixed model methodology will be used.


Other Outcome Measures:
  • Oncology physician and patient decision-making interaction on the likelihood of having a discussion related to geriatric domains during cancer treatment decision-making [ Time Frame: Baseline ]

Estimated Enrollment: 1056
Actual Study Start Date: June 26, 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (GA informational intervention)
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.
Other: Informational Intervention
Complete GA summary
Other Name: GA
Other: Questionnaire Administration
Ancillary studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Active Comparator: Arm II (usual care)
Patients and their caregivers (if participating) complete the GA at baseline.
Other: Informational Intervention
Complete GA summary
Other Name: GA
Other: Questionnaire Administration
Ancillary studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107443


Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
United States, Delaware
Delaware/Christiana Care NCORP
Newark, Delaware, United States, 19713
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Heartland NCORP
Decatur, Illinois, United States, 62526
United States, Kansas
Kansas City NCORP
Prairie Village, Kansas, United States, 66208
Wichita NCORP
Wichita, Kansas, United States, 67214
United States, Minnesota
Metro-Minnesota NCORP
Minneapolis, Minnesota, United States, 55426
United States, Nevada
Nevada NCORP
Las Vegas, Nevada, United States, 89106
United States, New York
North Shore LIJ Health System NCORP
Lake Success, New York, United States, 11042
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Southeast Clinical ONcology Research Consortium
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Columbus NCORP
Columbus, Ohio, United States, 43215
Dayton NCORP
Dayton, Ohio, United States, 45420
United States, Oregon
Pacific Cancer Research Consortium Ncorp
Portland, Oregon, United States, 97213
United States, Pennsylvania
Geisinger Cancer Institute NCORP
Danville, Pennsylvania, United States, 17822
United States, South Carolina
Greenville NCORP
Greenville, South Carolina, United States, 29615
United States, Wisconsin
Wisconsin NCORP
Marshfield, Wisconsin, United States, 54449
Aurora NCORP
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Supriya Mohile University of Rochester NCORP Research Base
  More Information

Responsible Party: Gary Morrow, Director, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT02107443     History of Changes
Other Study ID Numbers: URCC13070
NCI-2014-00619 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
URCC 13070 ( Other Identifier: University of Rochester )
URCC-13070 ( Other Identifier: DCP )
URCC-13070 ( Other Identifier: CTEP )
UG1CA189961 ( U.S. NIH Grant/Contract )
U10CA037420 ( U.S. NIH Grant/Contract )
CD-12-11-4634 ( Other Identifier: PCORI )
First Submitted: April 3, 2014
First Posted: April 8, 2014
Last Update Posted: June 2, 2017
Last Verified: June 2017