Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers
- Conditions
- Cognitive Impairment, MildCancer, Advanced
- Interventions
- Behavioral: Dyadic Life Review (DLR)
- Registration Number
- NCT05200572
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cancer Patients Dyadic Life Review (DLR) 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.
- Primary Outcome Measures
Name Time Method proportion of participants that complete the study week 14 proportion of participants that consent who are approached for the study baseline proportion of participants who state the intervention is acceptable during a qualitative interview week 14
- Secondary Outcome Measures
Name Time Method mean change in Perceived Stress Scale for caregivers 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.
mean change in the UCLA Loneliness Score for caregivers baseline to week 14 The scale of this instrument ranges from 0 to 10 with higher scores indicating more loneliness.
mean change in PROMIS29 domains 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.
mean change in the correlation between caregiver and patient distress 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.
mean change in Geriatric Depression Scale for caregivers 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.
mean change in Dyadic Adjustment Scale-7 for caregivers 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.
mean change in Dyadic Support Questionnaire 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.
mean change in Caregiver Reaction Scale for caregivers 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.
mean change in Unidimensional Relationship Closeness Scale for caregivers 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.
mean change in Distress Thermometer and Problem list for caregivers 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.
Trial Locations
- Locations (1)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States