NCT05144516 Cancer and Mild Cognitive Impairment Dyadic Intervention
| NCT ID | NCT05144516 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-09-30 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, gastrointestinal (GI), genitourinary (GU), or lung cancer (including extensive stage small cell lung cancer), diagnosed within two years; 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/Concerns 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: 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. At least one dyad member must experience distress.
Contact & Investigator
Katherine Ramos, Ph.D.
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT05144516 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05144516 currently recruiting?
Yes, NCT05144516 is actively recruiting participants. Contact the research team at Katherine.Ramos@duke.edu for enrollment information.
Where is the NCT05144516 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT05144516 clinical trial?
NCT05144516 is sponsored by Duke University. The principal investigator is Katherine Ramos, Ph.D. at Duke University. The trial plans to enroll 80 participants.
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