Cancer and Mild Cognitive Impairment a Patient-Caregiver Behavioral Intervention
Key facts
- Who runs it
- Duke University
- Where
- Durham, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 15 Jan 2022
- Expected to end
- 30 Nov 2026
- Type of study
- Interventional
- Treatments tested
- COPE +
- Record updated
- 19 January 2022
- Why it stopped
- Study halted prematurely, prior to enrollment of first participant
Who can take part
- Age
- 18 years to 100 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
- (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
Who cannot take part
- 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
- Participant has visual or hearing impairments that preclude participation
Where in United States
- Duke UniversityDurham, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Patient Caregiver DyadTreatment being tested
Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver.
Treatment: COPE +
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment
- Record updated
- 19 January 2022