Clinical trial NCT05200572: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Advanced
Cognitive Impairment, Mild
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute on Aging (NIA)
First posted: 2022-01-20
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).


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 scoring \<14.5 on the UBACC
* 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

Primary outcomes:
measure: proportion of participants that complete the study
timeFrame: week 14
measure: proportion of participants that consent who are approached for the study
timeFrame: baseline
measure: proportion of participants who state the intervention is acceptable during a qualitative interview
timeFrame: week 14
Secondary outcomes:
measure: mean change in the UCLA Loneliness Score for caregivers
timeFrame: baseline to week 14
measure: mean change in Unidimensional Relationship Closeness Scale for caregivers
timeFrame: baseline to week 14
measure: mean change in PROMIS29 domains
timeFrame: baseline to week 14
measure: mean change in Perceived Stress Scale for caregivers
timeFrame: baseline to week 14
measure: mean change in Caregiver Reaction Scale for caregivers
timeFrame: baseline to week 14
measure: mean change in Geriatric Depression Scale for caregivers
timeFrame: baseline to week 14
measure: mean change in Distress Thermometer and Problem list for caregivers
timeFrame: baseline to week 14
measure: mean change in Dyadic Adjustment Scale-7 for caregivers
timeFrame: baseline to week 14
measure: mean change in Dyadic Support Questionnaire
timeFrame: baseline to week 14
measure: mean change in the correlation between caregiver and patient distress
timeFrame: baseline to week 14
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: