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Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers

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ClinicalTrials.gov Identifier: NCT05436327
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : August 18, 2022
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
To improve patient-centered outcomes for older patients with cancer considering or receiving chemotherapy and their caregivers. To do this, the project team will (a) establish the effectiveness of GA on communication about age-related concerns, patient and caregiver satisfaction with communication about age-related concerns, quality of life, and patient-reported side effects of chemotherapy; (b) evaluate the success of the implementation strategies on the adoption, reach, and fidelity of implementing the GA in community oncology practices; and (c) identify the resources needed to implement GA and the GA-guided recommendations in community oncology practices for older patients considering or receiving chemotherapy.

Condition or disease Intervention/treatment Phase
Cancer Aging Communication Behavioral: Geriatric Assessment Not Applicable

Detailed Description:

Objectives:

  • Establish the effectiveness of GA on patient and caregiver satisfaction and communication about age-related concerns for older patients receiving chemotherapy in community oncology practices.
  • Evaluate the success of our implementation strategies on the reach, adoption, and fidelity of implementing the GA in community oncology practices.
  • Identify the resources needed to implement GA and the GA-guided recommendations in community oncology practices for older patients receiving chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers
Actual Study Start Date : May 6, 2022
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Geriatric Assessment (GA)
Clinical staff undergo training in GA and are provided with facilitation and support for one year as they implement GA among older adult patients (65+) considering chemotherapy and their care partners/caregivers.
Behavioral: Geriatric Assessment
Clinical staff receive (a) training in GA and workflow management strategies (<60 minutes) at baseline, (b) monthly facilitation and technical support calls (15-30 minutes) for 12 months, and (c) a group-based quarterly call for 12 months. For 12 months, clinical staff implement GA strategies during visits with older adult (65+) patients planning to receive new chemotherapy regimen and their care partners/caregivers.




Primary Outcome Measures :
  1. Reach of Geriatric Assessment (GA) implementation in routine medical practice [ Time Frame: monthly over 12 months of implementation, and 6 months after implementation ]
  2. Reach of Geriatric Assessment (GA) implementation in routine medical practice as measured by applying the reach formula (# people served divided by potential # of people) to the following four metrics: [ Time Frame: monthly over 12 months of implementation, and 6 months after implementation ]
    a) patients per month who received the Geriatric Assessment (GA), b) patients per month who received Geriatric Assessment (GA)-guided recommendations, c) total patients per month age 65+, d) total patients per month who were age 65+ and receiving new chemotherapy or deciding to start chemotherapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Practice Staff Participants

Inclusion Criteria:

  • Aged 18 years or older
  • A practicing clinician (e.g., oncologist, nurse practitioners, physician assistant, advanced practice nurse, registered nurse, medical assistant) or other practice staff (e.g., administrators and IT)
  • Fluent in English (reading and speaking)
  • Have access to computer, laptop, tablet, or smart phone

Exclusion Criteria:

  • Have plans to leave the practice in six months (e.g., retiring or changing organizations)
  • Unable to provide consent

Patient Participants

Inclusion Criteria:

  • Aged 65 and older
  • Considering a new chemotherapy plan

Exclusion Criteria:

• Have been diagnosed with a health condition that precludes their ability to participate in informed consent or in the intervention (e.g., dementia which limits decision-making capacity).

Care Partner/Caregiver Participants (Care partners can be any partner, spouse, family member, and/or friend that has been identified by the patient and/or clinical team that supports the patient through treatment.)

Inclusion Criteria:

  • Aged 18 years and older
  • Fluent in English (reading and speaking)
  • Have access to computer, laptop, tablet, or smart phone

Exclusion Criteria:

• Unable to provide consent

Inclusion of Special Populations:

Employees. The rationale for including employees is to gain a better understanding of how we can improve cancer care for older patients with cancer receiving chemotherapy. It is possible that some employees may be pregnant women or military personnel. We intend to include these individuals as long as they meet the inclusion and exclusion criteria because this is a clinical improvement project to promote the implementation of the GA in routine clinical practice and should have external validity. These individuals would not be excluded in other clinical improvement projects outside of a research study.

Other special populations. This study will not include other special subject populations (students, Non-English-Speaking Populations, Minors, Human Fetuses; Neonates (infants under 30 days old), prisoners/detainees (wards)) because the purpose of the study is to understand the implementation of the GA in clinical oncology practices and its impact on patients 65+ with cancer and their care partners satisfaction with care, communication about their care, quality of life, and patient (65+) reported toxicities.


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): NCT05436327


Contacts
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Contact: Lisa Marie Lowenstein, PhD, MPH 713-792-5807 LMLowenstein@mdanderson.org

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lisa Lowenstein, PhD, MPH    713-792-5807    LMLowenstein@mdanderson.org   
Principal Investigator: Lisa Lowenstein, PhD, MPH         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Lisa Marie Lowenstein, PhD, MPH M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05436327    
Other Study ID Numbers: 2021-0881
NCI-2022-05359 ( Other Identifier: NCI-CTRP Clinical Trials Processing Registry )
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No