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

Cognitive Impairment, Mild Clinical Trial

— urochester  

Official title:

Feasibility of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Mild Cognitive Impairment (MCI) and Their Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200572
• Other study ID #: STUDY00006662
• Secondary ID: T32CA102618
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: October 2023
• Source: University of Rochester
• Contact: Lee Kehoe, PhD
• Phone: 585-275-4625
• Email: lee_kehoe[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer, Advanced
• Cognitive Dysfunction
• Cognitive Impairment, Mild

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of participants that complete the study		week 14
Primary	proportion of participants that consent who are approached for the study		baseline
Primary	proportion of participants who state the intervention is acceptable during a qualitative interview		week 14
Secondary	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.	baseline to week 14
Secondary	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.	baseline to week 14
Secondary	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.	baseline to week 14
Secondary	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.	baseline to week 14
Secondary	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.	baseline to week 14
Secondary	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.	baseline to week 14
Secondary	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.	baseline to week 14
Secondary	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.	baseline to week 14
Secondary	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.	baseline to week 14
Secondary	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.	baseline to week 14