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

Primary Purpose

Cancer, Advanced, Cognitive Impairment, Mild

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dyadic Life Review (DLR)
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Advanced

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cancer Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

proportion of participants that complete the study
proportion of participants that consent who are approached for the study
proportion of participants who state the intervention is acceptable during a qualitative interview

Secondary Outcome Measures

mean change in the UCLA Loneliness Score for caregivers
The scale of this instrument ranges from 0 to 10 with higher scores indicating more loneliness.
mean change in Unidimensional Relationship Closeness Scale for caregivers
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.
mean change in PROMIS29 domains
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.
mean change in Perceived Stress Scale for caregivers
Measure the degree to which situations are appraised as stressful. This scale ranges from 0-40 with higher scores indicating higher perceived stress.
mean change in Caregiver Reaction Scale for caregivers
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.
mean change in Geriatric Depression Scale for caregivers
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.
mean change in Distress Thermometer and Problem list for caregivers
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.
mean change in Dyadic Adjustment Scale-7 for caregivers
This is a 7-item measure to assess relationship quality that ranges from 0-36 with higher scores indicating positive relationship quality.
mean change in Dyadic Support Questionnaire
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.
mean change in the correlation between caregiver and patient distress
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.

Full Information

First Posted
January 6, 2022
Last Updated
October 4, 2023
Sponsor
University of Rochester
Collaborators
National Cancer Institute (NCI), National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05200572
Brief Title
Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers
Official Title
Feasibility of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Mild Cognitive Impairment (MCI) and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Cancer Institute (NCI), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Advanced, Cognitive Impairment, Mild

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cancer Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dyadic Life Review (DLR)
Intervention Description
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 Measure Information:
Title
proportion of participants that complete the study
Time Frame
week 14
Title
proportion of participants that consent who are approached for the study
Time Frame
baseline
Title
proportion of participants who state the intervention is acceptable during a qualitative interview
Time Frame
week 14
Secondary Outcome Measure Information:
Title
mean change in the UCLA Loneliness Score for caregivers
Description
The scale of this instrument ranges from 0 to 10 with higher scores indicating more loneliness.
Time Frame
baseline to week 14
Title
mean change in Unidimensional Relationship Closeness Scale for caregivers
Description
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.
Time Frame
baseline to week 14
Title
mean change in PROMIS29 domains
Description
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.
Time Frame
baseline to week 14
Title
mean change in Perceived Stress Scale for caregivers
Description
Measure the degree to which situations are appraised as stressful. This scale ranges from 0-40 with higher scores indicating higher perceived stress.
Time Frame
baseline to week 14
Title
mean change in Caregiver Reaction Scale for caregivers
Description
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.
Time Frame
baseline to week 14
Title
mean change in Geriatric Depression Scale for caregivers
Description
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.
Time Frame
baseline to week 14
Title
mean change in Distress Thermometer and Problem list for caregivers
Description
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.
Time Frame
baseline to week 14
Title
mean change in Dyadic Adjustment Scale-7 for caregivers
Description
This is a 7-item measure to assess relationship quality that ranges from 0-36 with higher scores indicating positive relationship quality.
Time Frame
baseline to week 14
Title
mean change in Dyadic Support Questionnaire
Description
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.
Time Frame
baseline to week 14
Title
mean change in the correlation between caregiver and patient distress
Description
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.
Time Frame
baseline to week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Kehoe, PhD
Phone
585-275-4625
Email
lee_kehoe@urmc.rochester.edu
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Kehoe, PhD
Phone
585-275-4625
Email
lee_kehoe@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Lee Kehoe, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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