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Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05200572
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : June 21, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Lee Kehoe, University of Rochester

Brief Summary:
The purpose of this study is to test the feasibility of a telehealth Dyadic Life Review (DLR), adapted from individual Life Review Therapy, with caregivers of older adults with advanced cancer, including those with Mild Cognitive Impairment (MCI). The study will enroll 20 dyads of caregivers and older patients with advanced cancer and 20 dyads of caregivers and patients with advanced cancer and Mild Cognitive Impairment (MCI).

Condition or disease Intervention/treatment Phase
Cancer, Advanced Cognitive Impairment, Mild Behavioral: Dyadic Life Review (DLR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Mild Cognitive Impairment (MCI) and Their Caregivers
Actual Study Start Date : March 28, 2022
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Cancer Patients
Dyadic Life Review will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes.
Behavioral: Dyadic Life Review (DLR)
DLR will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes. Each session will facilitate a recall of each phase of life: childhood, adolescence, young adulthood, mid-life, earlier later life, and later life. While together, the patient and caregiver will each be asked structured questions to prompt reminiscence of memories from that phase of life.




Primary Outcome Measures :
  1. proportion of participants that complete the study [ Time Frame: week 14 ]
  2. proportion of participants that consent who are approached for the study [ Time Frame: baseline ]
  3. proportion of participants who state the intervention is acceptable during a qualitative interview [ Time Frame: week 14 ]

Secondary Outcome Measures :
  1. mean change in the UCLA Loneliness Score for caregivers [ Time Frame: baseline to week 14 ]
    The scale of this instrument ranges from 0 to 10 with higher scores indicating more loneliness.

  2. mean change in Unidimensional Relationship Closeness Scale for caregivers [ Time Frame: baseline to week 14 ]
    This measures the quality of the relationship with the care-receiver: assesses quality of relationship between participant and family member and has demonstrated valid scores across several relationship types, including spouses and other family members. The scale of this instrument ranges from 1 to 7 with higher scores indicating more closeness.

  3. mean change in PROMIS29 domains [ Time Frame: baseline to week 14 ]
    PROMIS29 assesses for seven domains of depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles. The scale of each domain of the instrument ranges from with 0-10 with higher scores indicating worse outcomes.

  4. mean change in Perceived Stress Scale for caregivers [ Time Frame: baseline to week 14 ]
    Measure the degree to which situations are appraised as stressful. This scale ranges from 0-40 with higher scores indicating higher perceived stress.

  5. mean change in Caregiver Reaction Scale for caregivers [ Time Frame: baseline to week 14 ]
    Items assess both positive and negative aspects of caregiving, have been shown to be responsive to intervention. Subscales: role captivity, overload, relational deprivation, competence, personal gain, family beliefs, family conflict, job conflict. The scale ranges from 0 to 24 with higher scores indicating a more negative caregiver experience.

  6. mean change in Geriatric Depression Scale for caregivers [ Time Frame: baseline to week 14 ]
    The purpose of this scale is to identify the clinical threshold of depression in older adults. The scale ranges from 0 to 15 with higher scores indicating worse depression.

  7. mean change in Distress Thermometer and Problem list for caregivers [ Time Frame: baseline to week 14 ]
    This tool is a 10-point self-report measure to capture distress and identify a list of sources of that distress. The scale ranges from 0-10 with higher scores indicating more distress.

  8. mean change in Dyadic Adjustment Scale-7 for caregivers [ Time Frame: baseline to week 14 ]
    This is a 7-item measure to assess relationship quality that ranges from 0-36 with higher scores indicating positive relationship quality.

  9. mean change in Dyadic Support Questionnaire [ Time Frame: baseline to week 14 ]
    This is an 18-item measure to assess individual's perceptions of received and provided support. The scale ranges from 0-145 with higher scores indicating better dyadic coping.

  10. mean change in the correlation between caregiver and patient distress [ Time Frame: baseline to week 14 ]
    Distress will be measured for patients and caregivers using the Distress Thermometer and Problem list tool. This tool is a 10-point self-report measure to capture distress and identify a list of sources of that distress. The scale ranges from 0-10 with higher scores indicating more distress. The change in the correlation of the scores between patients and caregivers will be calculated.



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.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patient Inclusion Criteria:

  • Age ≥ 65
  • Able to provide informed consent. All patients will be assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 56 - a score >14.5 will define ability to independently provide informed consent.
  • Eligible patients have Stage III or IV cancer of any type
  • Additionally, at least 20 patients will have a will have a high likelihood of MCI based on screening score of <26 on the Montreal Cognitive Assessment (MoCA) within their eRecord chart.
  • Able to read and understand English

Patient Exclusion Criteria:

  • Patients who do not have decision-making capacity (as determined by UBACC as described above) AND do NOT have a previously designated health care proxy (established prior to their cognitive impairment) available to sign consent.
  • Unable to identify caregiver to participate in study.

Caregiver Inclusion Criteria:

  • 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.
  • Caregivers will be selected by the patient when asked if there is a "family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") will remain eligible for the study.
  • Age 50 or older
  • Ability to provide consent
  • Proficient in English

Caregiver Exclusion Criteria

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

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): NCT05200572


Contacts
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Contact: Lee Kehoe, PhD 585-275-4625 lee_kehoe@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Lee Kehoe, PhD    585-275-4625    lee_kehoe@urmc.rochester.edu   
Principal Investigator: Lee Kehoe, PhD         
Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)
National Institute on Aging (NIA)
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Responsible Party: Lee Kehoe, Research Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT05200572    
Other Study ID Numbers: STUDY00006662
T32CA102618 ( U.S. NIH Grant/Contract )
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders