Clinical trial · Interventional
Cancer and Mild Cognitive Impairment Dyadic Intervention
A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment-2
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral: COPE + | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient Caregiver Dyad
- description
- Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver.
- interventionNames
- Behavioral: Behavioral: COPE +
Primary outcomes (2)
- measure
- Number of completed sessions as measured by enrollment log
- timeFrame
- Up to 17 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 17 weeks
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available