Caregivers-Patients Support to Cope With Advanced-Cancer (CASA) Pilot Study.

Обзор

The proposed study will follow a mixed-methods pilot study. The intervention trial will involve conducting an adapted Caregivers-Patients Support intervention to Cope with Advanced-Cancer (CASA) randomized clinical trial framed under the the collaborative intervention planning framework. The team will collect data for primary outcome (Spiritual Well-Being Scale) and secondary outcomes. The secondary outcomes include Hospital Anxiety and Depression Scale (HADS), Beck Hopelessness Scale (BHS), Functional Assessment of Cancer Therapy-General (FACT-G), Family Relationship Index, Holding Back subscale, Zarit Burden Interview (ZBI), and NCCN Distress Thermometer. All measures are available in Spanish and the team has used them in previous studies with Hispanic/Latinx patients and caregivers coping with advanced cancer. Highly innovative analyses exploring feasibility and preliminary effect. Definitions of feasibility will include: (1) ≥60% enrollment among approached participants, (2) ≥70% completion of baseline and T2 surveys; (3) ≥80% of participants in the intervention group agreeing with the item CASA was helpful to me; and (4) ≤20% of respondents in the intervention group agreeing with the item CASA placed a considerable burden on me. Preliminary effects evaluation will include: a linear mixed effect modeling and an intent-to-treat approach to analyze the results. The results of FACIT, FRI, HBS, HADS, BHS, DT, FACT-G, and ZB will be analyzed with a paired t-test, Wilcoxon signed ranks test, and McNemar. Linear mixed effect modeling is statistically appropriate because we will use one independent variable (CASA intervention) with more than two dependent/matched groups (patients-control, caregivers-control, patients-in-treatment, caregivers-in-treatment, patients-caregiver-control, and patients-caregivers-in-treatment). The primary outcome is pre- to post-intervention changes in spirituality (FACIT). Change scores have the advantage of clearly showing the direction of change. The linear mixed effects model analysis will include two primary fixed-effect covariates: 1) spirituality to provide some control over variability in participants baseline; and 2) treatment assignment (CASA vs. control group). The same approach will be used for the secondary outcomes (FACT-IT, HADS, BHS, DT, FACT-G, and ZB). Qualitative Analyses. Interviews will be digitally recorded with consent and analyzed thematically using a matrix. Each thematic matrix will contain data from the interviews pertaining to the theme in question, alongside participant information (demographics, changes in scores). The qualitative analysis will help explain the feasibility/acceptability. The team will implement minor refinements to enhance the relevance of the CASA intervention for the target population and context.

Вмешательства

• Поведенческое Experimental: CASA
  The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be delivered to patients and caregivers. The sessions follow a protocol and will be held weekly or bi-weekly for a total of 5 sessions.
• Поведенческое Placebo Comparator: Usual Care
  Usual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions.

Первичные конечные точки

• Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp) [Срок оценки: [Time Frame: 5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)]]

Критерии участия

Критерии включения

• Cancer patients must be stage III and IV solid tumor patients who report distress >4 on the Distress Thermometer
• Caregivers. Identified caregivers by distressed patients

Критерии исключения

• diagnosed with a major disabling medical or psychiatric condition
• unable to understand the consent procedure, or
• too ill to participate, all as reported by the participant and/or determined by the investigator's judgment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Пуэрто-Рико · 1 центр

• Ponce Health Science University — Ponce

Идентификаторы

NCT: NCT07639268 · 45562

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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