Cancer, Cognitive Impairment
Conditions
Keywords
Aging, Behavioral Intervention, Mental Health, Communication
Brief summary
The purpose of this study is to see whether programs that include both a patient and their spouse or a patient and family caregiver (known as a dyad) are helpful for families in which one member of the dyad has cancer and mild memory difficulties and/or concerns. Participant and their spouse or participant and their family caregiver will have six, 60-minute video-conference sessions which will be scheduled at their convenience. The investigator will loan participants a tablet computer (iPad) to use for videoconferencing and train the participant in its use. Participant and their spouse or participant and their family caregiver will complete three assessments - one before starting the sessions, one after the sixth session, and one after 1 month. Each assessment will include surveys, which the participant will complete separately from their spouse or family caregiver. For most people, it will take upwards of 2 - 4 months to complete this study.
Interventions
BEHAVIORALCOPE +
Six sixty minute sessions that teaches participants distress and communication coping skills.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Patient inclusion criteria include: 1. Patients with Stage I-IV breast, colon, rectal, or lung cancer (newly diagnosed within 6 months; age 65 or older. 2. Participants must be living at home (either in her/his own home). 3. Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions. 4. Exhibit Mild Cognitive Impairment. 5. Have an informal family caregiver. Inclusion Criteria: (Partner or family member) inclusion criteria include: 1. Caregivers are 18 older. 2. Be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions. 3. Either co-reside with the patient or spend at least 3-4 hours day caregiving. 4. Not exhibit cognitive impairment.
Exclusion criteria
for both patients and caregivers: 1. Participant has visual or hearing impairments that preclude participation. 2. Participant has dementia and do not have the capacity to participate. 3. Have a serious untreated psychiatric illness as documented in medical chart review. 4. The patient and the caregiver score less than a 3 on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) on a scale 0 to 10 to screen for distress.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of completed sessions as measured by enrollment log | Up to 10 weeks | — |
| Number of participants who are satisfied with the intervention as measured by a score of 24 or greater on the CSQ-8 | Up to 10 weeks. | The Client Satisfaction Questionnaire (CSQ-8) is a self report measure of satisfaction with health and behavioral services received. The CSQ-8 is measured on a four point Likert scale from 1 Quite Dissatisfied to 4 Very Satisfied. Scores range from 8-32, with higher values indicating higher satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Distress as measured by the DASS-21 | Up to 10 weeks. | The Depression, Anxiety, and Stress Scale (DASS-21) measure will be used for rating general distress across three emotional states of depression, anxiety, and stress. The measure has a total of 21 items. Scores range from 0- 63, with higher scores indicating greater distress. |
| Change in Quality of Life as measured by the FACT-G | Up to 10 weeks. | The Functional Assessment of Cancer Therapy: General (FACT-G) measure will be used for rating quality of life. The measure has a total of 27 items. Scores range from 0-108, with higher scores indicating greater quality of life. |
| Change in Communication Patterns as measured by the CPQ-SF | Up to 10 weeks. | The Communication Patterns Questionnaire Short-Form (CPQ-SF) will be used for rating communication patterns in a relationship. The measure has a total of 11 items. Scores range from 11-99, higher scores indicate a greater likelihood of using a particular communication pattern during conflict interactions. |
| Change in Relationship Satisfaction as measured by the Mutuality Scale of the Family Care Inventory | Up to 10 weeks. | The Mutuality Scale of the Family Care Inventory will be used for rating mutual concerns and overall relationship satisfaction. The measure consists of 15 items. Scores range from 0-60, higher scores indicate greater relationship satisfaction. |
Countries
United States
Outcome results
None listed