Cancer and Mild Cognitive Impairment a Patient-Caregiver Behavioral Intervention

Study Overview
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Brief Summary
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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.

Official Title
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A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment

Conditions
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Cancer, Cognitive Impairment

Intervention / Treatment
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* Behavioral: COPE +


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient inclusion criteria include: Patients with Stage I-IV breast, colon, rectal, or lung cancer (newly diagnosed within 6 months; age 65 or older. Participants must be living at home (either in her/his own home). Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions. Exhibit Mild Cognitive Impairment. Have an informal family caregiver. Inclusion Criteria: (Partner or family member) inclusion criteria include: Caregivers are 18 older. Be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions. Either co-reside with the patient or spend at least 3-4 hours day caregiving. Not exhibit cognitive impairment. Exclusion Criteria for both patients and caregivers: Participant has visual or hearing impairments that preclude participation. Participant has dementia and do not have the capacity to participate. Have a serious untreated psychiatric illness as documented in medical chart review. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Caregiver Dyad<br>Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver. | Behavioral: COPE +<br>* Six sixty minute sessions that teaches participants distress and communication coping skills.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Up to 10 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Distress as measured by the DASS-21 | 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. | Up to 10 weeks. | 
| Change in Quality of Life as measured by the FACT-G | 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. | Up to 10 weeks. | 
| Change in Communication Patterns as measured by the CPQ-SF | 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. | Up to 10 weeks. | 
| Change in Relationship Satisfaction as measured by the Mutuality Scale of the Family Care Inventory | 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. | Up to 10 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Behavioral Intervention, Mental Health, Communication