Back to resultsCancer and Mild Cognitive Impairment a Patient-Caregiver Behavioral Intervention
Primary Purpose
Cancer, Cognitive Impairment
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COPE +
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring Aging, Behavioral Intervention, Mental Health, Communication
Eligibility Criteria
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.
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient Caregiver Dyad
Arm Description
Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver.
Outcomes
Primary Outcome Measures
Number of completed sessions as measured by enrollment log
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04826315
Brief Title
Cancer and Mild Cognitive Impairment a Patient-Caregiver Behavioral Intervention
Official Title
A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study halted prematurely, prior to enrollment of first participant
Study Start Date
January 15, 2022 (Anticipated)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cognitive Impairment
Keywords
Aging, Behavioral Intervention, Mental Health, Communication
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Caregiver Dyad
Arm Type
Experimental
Arm Description
Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver.
Intervention Type
Behavioral
Intervention Name(s)
COPE +
Intervention Description
Six sixty minute sessions that teaches participants distress and communication coping skills.
Primary Outcome Measure Information:
Title
Number of completed sessions as measured by enrollment log
Time Frame
Up to 10 weeks
Title
Number of participants who are satisfied with the intervention as measured by a score of 24 or greater on the CSQ-8
Description
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.
Time Frame
Up to 10 weeks.
Secondary Outcome Measure Information:
Title
Change in Distress as measured by the DASS-21
Description
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.
Time Frame
Up to 10 weeks.
Title
Change in Quality of Life as measured by the FACT-G
Description
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.
Time Frame
Up to 10 weeks.
Title
Change in Communication Patterns as measured by the CPQ-SF
Description
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.
Time Frame
Up to 10 weeks.
Title
Change in Relationship Satisfaction as measured by the Mutuality Scale of the Family Care Inventory
Description
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.
Time Frame
Up to 10 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Ramos, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cancer and Mild Cognitive Impairment a Patient-Caregiver Behavioral Intervention
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