CancerNCT05144516
Cancer and Mild Cognitive Impairment Dyadic Intervention
A study testing Behavioral: COPE + in people with Cancer and Cognitive Impairment, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer, Cognitive Impairment
- What is being tested?
- Behavioral: COPE +
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- (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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27705
About this study
Official title: A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment-2
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
- Cancer, Cognitive Impairment
- Being tested
- Behavioral: COPE +
- Keywords
- Aging, Behavioral Intervention, Mental Health, Communication
- Medical subject headings
- Neoplasms, Cognitive Dysfunction, Psychological Well-Being, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: COPE +Behavioural
Six sixty minute sessions that teaches participants distress and communication coping skills.
| Study group | Role | What they receive |
|---|---|---|
| Patient Caregiver Dyad | Experimental | Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver. Receives: Behavioral: Behavioral: COPE + |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of completed sessions as measured by enrollment log
Measured: 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
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
Measured: Up to 17 weeks
Secondary outcomes (4)
Change in Distress as measured by the DASS-21
The Depression, Anxiety, and Stress Scale (DASS-21) measure will be used for rating general distress across three emotional states of depression, anxiety, and stress. The measure has a total of 21 items. Scores range from 0- 63, with higher scores indicating greater distress.
Measured: Baseline, up to 17 weeks, up to 1 month follow up
Change in Quality of Life as measured by the FACT-G
The Functional Assessment of Cancer Therapy: General (FACT-G) measure will be used for rating quality of life. The measure has a total of 27 items. Scores range from 0-108, with higher scores indicating greater quality of life.
Measured: Baseline, up to 17 weeks, up to 1 month follow up
Change in Communication Patterns as measured by the CPQ-SF
The Communication Patterns Questionnaire Short-Form (CPQ-SF) will be used for rating communication patterns in a relationship. The measure has a total of 11 items. Scores range from 11-99, higher scores indicate a greater likelihood of using a particular communication pattern during conflict interactions.
Measured: 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
The Mutuality Scale of the Family Care Inventory will be used for rating mutual concerns and overall relationship satisfaction. The measure consists of 15 items. Scores range from 0-60, higher scores indicate greater relationship satisfaction
Measured: Baseline, up to 17 weeks, up to 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start30 Sep 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Ramos, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144516
- Sponsor's protocol ID
- Pro00109148
- Status last verified
- Feb 2026
- First submitted
- 22 Nov 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment-2
- ClinicalTrials.gov ID
- NCT05144516
- Acronym / sponsor ID
- Pro00109148
- Conditions
- Cancer, Cognitive Impairment
- Keywords
- Aging, Behavioral Intervention, Mental Health, Communication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Caregiver Dyad | Experimental | Behavioral: Behavioral: COPE +Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: COPE +Six sixty minute sessions that teaches participants distress and communication coping skills. | Behavioural | Patient Caregiver Dyad |
Primary outcome
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
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Ramos, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: COPE + in people with Cancer and Cognitive Impairment, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Ramos, Ph.D. (9194163434, Katherine.Ramos@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of completed sessions as measured by enrollment log (time frame: Up to 17 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.