Cancer and Mild Cognitive Impairment Dyadic Intervention
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Patient Caregiver Dyad Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver. |
Behavioral: Behavioral: COPE +
Six sixty minute sessions that teaches participants distress and communication coping skills.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Change in Distress as measured by the DASS-21 [Baseline, 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 [Baseline, 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 [Baseline, 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 [Baseline, 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
Eligibility Criteria
Criteria
Inclusion Criteria:
Patient inclusion criteria include:
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Patients with Stage I-IV breast, colon, rectal, or lung cancer (newly diagnosed within 6 months); age 65 or older.
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Participants must be living at home (either in her/his own home).
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Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
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Exhibit Mild Cognitive Impairment/Concerns
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Have an informal family caregiver.
Inclusion Criteria:
(Partner or family member) inclusion criteria include:
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Caregivers are 18 older.
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Be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
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Either co-reside with the patient or spend at least 3-4 hours day caregiving.
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Not exhibit cognitive impairment.
Exclusion Criteria:
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Participant has visual or hearing impairments that preclude participation.
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Participant has dementia and do not have the capacity to participate.
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Have a serious untreated psychiatric illness as documented in medical chart review.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Duke University | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Katherine Ramos, Ph.D., Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00109148