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De klinische studie NCT06172907 (YAD) voor KANKER, Overleving, Zorgverlenerlast, Psychologische stress, Omgangsvaardigheden, Stellen is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers (YAD)
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De klinische studie NCT06172907 (YAD) is een interventioneel studie bij KANKER, Overleving, Zorgverlenerlast, Psychologische stress, Omgangsvaardigheden, Stellen met de status recruterend. Het doel is om 20 deelnemers te includeren vanaf 19 april 2024. De studie wordt geleid door Massachusetts General Hospital en de voltooiing is gepland op 1 juni 2026. Laatste update op ClinicalTrials.gov: 11 augustus 2025.
Beknopte samenvatting
The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.
Uitgebreide beschrijving
Young adults (YA) with cancer have unique challenges in coping, and their primary partners may experience burden and low self-efficacy related to caregiving. In this single-arm pilot trial, the investigators shall deliver an eight-session intervention to YAs with cancer and their self-identified partners who provide caregiving. The intervention is founded on principles from cognitive-behavioral therapy and couples-focused interventions, tailored for YA. The aim of the study is to assess the feasibility and acceptability of the intervention, which will inform refinements prior to a larger-scale clinical trial. This study will include 10 YAs and their partner-caregivers (N=20). Participants will complete surveys at baseline and after the intervention, and will be invited to complete optional semi-structured exit interviews.
Officiële titel
A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers
Aandoeningen
KANKEROverlevingZorgverlenerlastPsychologische stressOmgangsvaardighedenStellenAndere studie-ID's
- YAD
- 23-472
NCT-ID
Startdatum (Werkelijk)
2024-04-19
Laatste update geplaatst
2025-08-11
Verwachte einddatum
2026-06
Inschrijving (Geschat)
20
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Trefwoorden
Young Adult Cancer
Cancer Caregiving
Cancer Caregiving
Primaire doel
Ondersteunende zorg
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
OverigeYoung Adults Coping with Cancer Together Intervention Young adults with cancer and their partner-caregivers will attend dyadic virtual psychotherapy sessions lasting 45-60 minutes on a weekly basis for eight weeks. | Young Adults Coping with Cancer Together Intervention This intervention is based on cognitive-behavioral therapy and couples' therapy. It aims to improve cancer and caregiving-related self-efficacy and coping, as well as promote relationship maintenance in context of cancer. The intervention will be delivered by a trained mental health practitioner and include didactics, experiential exercises, and home practice. |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Feasibility of Intervention | Feasibility will be measured by measured by participant rates of enrollment (≥50% of those eligible), participant retention (≥70% of those enrolled), and intervention attendance (≥70% attending at least 6 of 8 sessions). | 10 +/- 2 Weeks |
Acceptability of Intervention | Acceptability with be measured by satisfaction with the intervention as rated on the Client Satisfaction Questionnaire. The intervention will be deemed acceptable if ≥75% of participants report average satisfaction that exceeds the CSQ's midpoint. | 10 +/- 2 Weeks |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene
Minimumleeftijd
25 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Either: (1) Currently receiving active cancer treatment (n=5) or are within two years of completing active treatment (n=5) at Massachusetts General Cancer Center (MGHCC), located in Boston, Massachusetts, United States, OR (2) are the partner of an individual between the ages of 25-39 who is currently receiving treatment at MGHCC (n=5) or who has completed cancer treatment at MGHCC within the past two years (n=5)
- Either: (1) Indicates a score ≥4 on the National Comprehensive Cancer Network (NCCN) adapted distress thermometer study screening questions, OR (2) are the partner of a participant indicating a score ≥4 on the NCCN adapted distress thermometer study screening questions
- English-speaking
• Uncontrolled psychosis, active suicidal ideation, or cognitive impairment
Massachusetts General HospitalVerantwoordelijke instantie
Jamie Jacobs, Hoofdonderzoeker, Assistant Professor, Harvard Medical School Department of Psychiatry, Massachusetts General Hospital
Centraal Contactpersoon
Contact: Jamie M Jacobs, Ph.D., 617-643-1777, [email protected]
Contact: Zeba N Ahmad, Ph.D., 617-724-1586, [email protected]
4 Studielocaties in 1 landen
Massachusetts
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02114, United States
Jamie M Jacobs, PhD, Contact
Jamie M Jacobs, PhD, Hoofdonderzoeker
Recruterend
Emerson Hospital/MGH Cancer Center, Concord, Massachusetts, 01742, United States
Jamie M Jacobs, PhD, Contact
Jamie M Jacobs, PhD, Hoofdonderzoeker
Recruterend
Mass General at North Shore Cancer Center, Danvers, Massachusetts, 01923, United States
Jamie M Jacobs, PhD, Contact
Jamie M Jacobs, PhD, Hoofdonderzoeker
Recruterend
Mass General at Newton Wellesley Hospital, Newton, Massachusetts, 02462, United States
Jamie M Jacobs, PhD, Contact
Jamie M Jacobs, PhD, Hoofdonderzoeker
Recruterend