Skip to content

Palliative Care for Lymphoma with early navigation and outcomes (PLENO study): a randomized controlled trial

Early palliative care in patients with relapsed/refractory Non-Hodgkin Lmphoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7pjj8mk
Enrollment
Unknown
Registered
2025-07-30
Start date
2025-07-01
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

Diffuse Large B-Cell Lymphoma

Interventions

This is a controlled, randomized, and unblinded clinical study involving patients with relapsed or refractory aggressive Non-Hodgkin Lymphomas, assessing the integration of early palliative care (with

Sponsors

Oncoclínicas Rio de Janeiro S.A
Lead Sponsor
Oncoclínicas Rio de Janeiro S.A
Collaborator
Grupo Oncoclínicas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diffuse Large B-Cell Lymphoma (DLBCL); Primary Central Nervous System Lymphoma (PCNSL); HTLV-associated Lymphoma, Burkitt Lymphoma; Mantle Cell Lymphoma (MCL); Primary Mediastinal Large B-Cell Lymphoma (PMBCL); Peripheral T-Cell Lymphoma (PTCL); transformed indolent Non-Hodgkin Lymphoma; both male or female; over 18 years old; followed in outpatient settings; capable of responding to the required information or accompanied by someone able to do so; who sign the informed consent form

Exclusion criteria

Exclusion criteria: Individuals under 18 years of age; patients who refuse to participate; patientse with a histopathological diagnosis of indolent Non-Hodgkin Lymphoma of the following subtypes: Follicular, Cutaneous T-Cell, and Lymphoplasmacytic

Design outcomes

Primary

MeasureTime frame
It is expected that there will be a change in the FACT-Lym score from baseline to 12 weeks after the integration of palliative care into oncohematological treatment

Secondary

MeasureTime frame
To evaluate changes in the scores of the Edmonton Symptom Assessment Scale (ESAS) and the Hospital Anxiety and Depression Scale (HADS), as well as the incidence of treatment in the last 30 days of life, the number of emergency admissions, the location and length of hospitalization, the time and place of death, and overall survival

Countries

Brazil

Contacts

Public ContactCecilia Vaz

Oncoclínicas Botafogo

cecilia.vaz@medicos.oncoclinicas.com+552121270250

Outcome results

None listed

Source: REBEC (via WHO ICTRP)