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Validation of the questionnaire for Portuguese (Brazil) and evaluation of the effect of the Posthumous Dignity Therapy intervention in bereaved informal caregivers

Posthumous Dignity Therapy: validation of the questionnaire for Portuguese (Brazil) and evaluation of the effect of the dignity therapy intervention in bereaved informal caregivers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6vfbzj6
Enrollment
Unknown
Registered
2023-07-14
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mourning

Interventions

This will be a randomized clinical trial with a control group, with a descriptive and qualitative methodological design. In this phase of the study, the Posthumous Dignity Therapy guiding questions pr
moment 2, when researcher 2 (doctoral student) will conduct a follow-up consultation, in person or online, addressing issues concerning grief with the open question: "How have you been feeling since t
N02.421.585.905.400

Sponsors

Instituto de Câncer de Londrina
Lead Sponsor
Instituto de Câncer de Londrina
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Bereaved informal caregivers of patients cared for by the Oncology Palliative Care Team at the Londrina Cancer Hospital; informal caregivers of patients in the active death process or who have already died cared for by the Team; over 18 years of age of both genders; previously elected by patients or the healthcare team as the patients’ main caregivers; who write, speak or read Brazilian Portuguese; with cognitive capacity to understand questions and answers, which will be evaluated by the researcher; willing to meet researchers for up to 3 consecutive meetings at an interval of approximately 45 days in total, in person or online

Exclusion criteria

Exclusion criteria: Previous or ongoing psychiatric disorders; caregivers presenting criteria for diagnosis of depression using the PHQ-9 questionnaire (9-item Patient Health Questionnaire), which will be applied before the TCLE (Informed Consent Form), with the aim of screening for suicidal ideation or depression

Design outcomes

Primary

MeasureTime frame
Reduction in anxiety and depression levels identified by the HADS (Hospital Anxiety and Depression Scale), with the variables HADS-A (anxiety) and HADS-D (depression) dichotomized at cutoff points based on the literature, that is, greater than or equal to 9 in each of these spheres (anxiety and depression), with the improvement in the depressive and anxious scores considered a decrease of 2 points or more in the value of these scores

Secondary

MeasureTime frame
It is intended to demonstrate improvement in the scores of inner peace and spiritual pain by the ESAS scale (Edmonton Symptom Scale). This scale consists of numeric responses from 0 to 10, zero being the absence of the symptom and 10 the symptom in its most intense form, and it is expected to obtain, after the intervention, a decrease in the score given by the patient to the symptom, thus characterizing the improvement of the symptom;It is expected to find improvement in spiritual well-being scores by the FACIT-Sp 12 (Functional Assessment of Chronic Illness Therapy – Spiritual Well-being Scale), a scale containing 12 items, self-administered and comprehensive to broadly assess spirituality, meaning and purpose in life, harmony, peace, and the sense of comfort and strength that come from faith. Respondents choose a five-point Likert-type agreement response for each of the statements, which can vary from “not at all” to “very much”. After the intervention, the improvement in these domains will be evaluated by changing the response to others closer to "very much" in each domain;Assessment regarding the acceptance or not of the caregiver in relation to Posthumous Dignity Therapy, which will be evaluated through a specific study question: How was it for you to participate in this study? The answers will be evaluated in terms of content through content analysis (Beaton's methodology) and responses with an acceptance speech will be considered positive

Countries

Brazil

Contacts

Public ContactAna Carolina ;Bianca Kotinda Bennemann;Sakamoto Ribeiro Paiva

Hospital do Cancer de Londrina;Hospital do Câncer de Barretos

anakotinda@hotmail.com;bsrpaiva@gmail.com+55(43)3379-2600;+55(17)3321-6600

Outcome results

None listed

Source: REBEC (via WHO ICTRP)