Cancer and Mild Cognitive Impairment a Patient-Caregiver Behavioral Intervention

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04826315
• Other study ID #: Pro00107680
• Status: Withdrawn
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: November 30, 2026

Study information

• Verified date: January 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Patient inclusion criteria include:

1. Patients with Stage I-IV breast, colon, rectal, or lung cancer (newly diagnosed within 6 months; 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.

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 for both patients and caregivers:

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.

Related Conditions & MeSH terms

• Cancer
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of completed sessions as measured by enrollment log		Up to 10 weeks
Primary	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.	Up to 10 weeks.
Secondary	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.	Up to 10 weeks.
Secondary	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.	Up to 10 weeks.
Secondary	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.	Up to 10 weeks.
Secondary	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.	Up to 10 weeks.