Cancer
Conditions
Keywords
Older Adults, Geriatric Oncology, Caregivers
Brief summary
The purpose of this study is to test the feasibility of a pilot Randomized Controlled Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to social work.
Detailed description
The purpose of this study is to test the feasibility of a pilot Randomized Controlled Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to social work. The study will enroll dyads (pairs) of caregivers and older patients with advanced cancer and dyads of caregivers and patients with advanced cancer. A previous single-arm study was performed testing the feasibility of the adapted DLR intervention in older adults with advanced cancer and their caregivers. The single-arm pilot demonstrated DLR was feasible and acceptable by both patients and caregivers. This innovative pilot study will gather data to test the feasibility of a pilot and examine pre-post intervention changes in caregiver psychological distress.
Interventions
BEHAVIORALDyadic Life Review
DLR is an intervention that will promote relationship closeness, communication, and psychological distress in both older adults and caregivers.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * Age ≥ 65 * Patient has a Stage III or IV advanced cancer diagnosis of any type * Score of 4 or more on National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT)\* * Able to read and understand English Patient
Exclusion criteria
• Unable to identify caregiver to participate in study Caregiver Inclusion Criteria: * One caregiver must enroll with each patient for either subject to be eligible. * Caregivers will be selected by the patient when asked if there is a "significant other, spouse, romantic partner, or adult child with whom you discuss or can be helpful in health-related matters;" * Age 50 or older * Able to reach and understand English Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLR Intervention Enrollment Rate | 18 weeks | Evaluate the feasibility of DLR in older patients and caregivers based on enrollment rate. |
| DLR Intervention Retention Rate | 18 weeks | Evaluate the feasibility of DLR in older patients and caregivers based on retention rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unidimensional Relationship Closeness Scale | 18 weeks | Quality of relationship with 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. This is a 12-item scale, rated from 1-7 (1=strongly agree, 7=strongly disagree), with a possible total of 84; a higher score indicates a higher level of closeness. |
| Communication Satisfaction Scale | 18 weeks | The observation of each partner's level of satisfaction with various aspects of their communication. This is a 12-item scale, rated from 1-5 (1=not at all satisfied, 5=extremely satisfied), with a possible total of 60; a higher score indicates greater satisfaction with communication. |
| Distress Thermometer | 18 weeks | A self-report measure to capture distress and identify a list of sources of that distress. This is a 10-item scale, rated from 0-10 (0=no distress, 10=severe distress), with a possible total of 10; a higher score indicates greater distress. |
Countries
United States
Outcome results
None listed