Cancer and Mild Cognitive Impairment Dyadic Intervention

Official title

A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment-2

Overview

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

• Behavioral Behavioral: COPE +
  Six sixty minute sessions that teaches participants distress and communication coping skills.

Primary outcome measures

• Number of completed sessions as measured by enrollment log [Time frame: Up to 17 Weeks]
• Number of participants who are satisfied with the intervention as measured by a score of 24 or greater on the CSQ-8 [Time frame: Up to 17 weeks]

Secondary outcome measures (4)

• Change in Distress as measured by the DASS-21 [Time frame: Baseline, up to 17 weeks, up to 1 month follow up]
• Change in Quality of Life as measured by the FACT-G [Time frame: Baseline, up to 17 weeks, up to 1 month follow up]
• Change in Communication Patterns as measured by the CPQ-SF [Time frame: Baseline, up to 17 weeks, up to 1 month follow up]
• Change in Relationship Satisfaction as measured by the Mutuality Scale of the Family Care Inventory [Time frame: Baseline, up to 17 weeks, up to 1 month follow up]

Eligibility criteria

Inclusion criteria

Patient inclusion criteria include:

• Patients with Stage I-IV breast, gastrointestinal (GI), genitourinary (GU), or lung cancer (including extensive stage small cell lung cancer), diagnosed within two years; 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/Concerns
• 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

• 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. At least one dyad member must experience distress.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Duke University — Durham

Identifiers

NCT: NCT05144516 · Pro00109148

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗