- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04826315
Cancer and Mild Cognitive Impairment a Patient-Caregiver Behavioral Intervention
4. januar 2022 oppdatert av: Duke University
A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment
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.
Studieoversikt
Studietype
Intervensjonell
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Duke University
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 100 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
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.
Inclusion Criteria:
(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.
Exclusion Criteria for both patients and caregivers:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Pasientbehandler Dyad
Deltakere som er 65 år eller eldre med kreft og lett kognitiv svikt med sin omsorgsperson.
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Six sixty minute sessions that teaches participants distress and communication coping skills.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of completed sessions as measured by enrollment log
Tidsramme: Up to 10 weeks
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Up to 10 weeks
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Number of participants who are satisfied with the intervention as measured by a score of 24 or greater on the CSQ-8
Tidsramme: Up to 10 weeks.
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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.
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Up to 10 weeks.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Distress as measured by the DASS-21
Tidsramme: Up to 10 weeks.
|
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.
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Up to 10 weeks.
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Change in Quality of Life as measured by the FACT-G
Tidsramme: Up to 10 weeks.
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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.
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Up to 10 weeks.
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Change in Communication Patterns as measured by the CPQ-SF
Tidsramme: Up to 10 weeks.
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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.
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Up to 10 weeks.
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Change in Relationship Satisfaction as measured by the Mutuality Scale of the Family Care Inventory
Tidsramme: Up to 10 weeks.
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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.
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Up to 10 weeks.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
15. januar 2022
Primær fullføring (Forventet)
30. november 2026
Studiet fullført (Forventet)
30. november 2026
Datoer for studieregistrering
Først innsendt
29. mars 2021
Først innsendt som oppfylte QC-kriteriene
29. mars 2021
Først lagt ut (Faktiske)
1. april 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. januar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. januar 2022
Sist bekreftet
1. januar 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00107680
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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