Clinical trial NCT04826315: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer
Cognitive Impairment
Keywords: Aging
Behavioral Intervention
Mental Health
Communication
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of completed sessions as measured by enrollment log
timeFrame: Up to 10 weeks
measure: Number of participants who are satisfied with the intervention as measured by a score of 24 or greater on the CSQ-8
timeFrame: Up to 10 weeks.
Secondary outcomes:
measure: Change in Distress as measured by the DASS-21
timeFrame: Up to 10 weeks.
measure: Change in Quality of Life as measured by the FACT-G
timeFrame: Up to 10 weeks.
measure: Change in Communication Patterns as measured by the CPQ-SF
timeFrame: Up to 10 weeks.
measure: Change in Relationship Satisfaction as measured by the Mutuality Scale of the Family Care Inventory
timeFrame: Up to 10 weeks.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Katherine Ramos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: