Clinical trial NCT04153019: PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR CANCER CACHEXIA (PRICC)
Official title: PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR THE ONCOLOGICAL PATIENT WITH CACHEXIA AND HIS CAREGIVER: A FEASIBILITY STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Cachexia
Keywords: cancer cachexia
psychoeducational intervention
rehabilitative intervention
dyad
palliative care
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2019-11-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Half of all cancer patients experience cachexia, with the prevalence rising above 80% in the last weeks of life. The cancer cachexia is a complex relational experience which involves the dyads patients-families. There are no studies on psychosocial interventions on dyads associated with rehabilitative interventions, to support more functional relationships to the management of cancer cachexia.

Primary objective: to evaluate the feasibility of a psycho-educational intervention combined with a physiotherapy intervention on the dyads. Secondary objective: improvement of the Quality of Life of dyads, acceptability of the intervention, adherence to each of the two components.

Methods: non-pharmacological interventional perspective, mixed-method study, addressed to a consecutive 30 cancer patients with cachexia and irreversible cachexia and their caregivers assisted by Hospital Palliative Care Unit.


Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older
* Good command of the Italian language
* Written informed consent
* Histologically confirmed tumor diagnosis
* Presence of irreversible cachexia and cachexia (ESPEN3-5 guidelines, MUST calculation)
* Patients who have identified a caregiver
* Patients and family members are informed of the diagnosis and the objectives of the therapies and who have reported awareness of the disease phase (evaluated by the palliative doctor).

Exclusion Criteria:

* Patients with prognosis less than three months to enable the rehabilitative intervention
* Presence of important mental disorder or dementia
* Severe sensory deficit
* Presence of diffuse bone metastases that put the patient at risk of fracture during rehabilitation exercise.

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: After 2 months
Secondary outcomes:
measure: Functional Assessment of Anorexia-Cachexia Therapy (FAACT)
timeFrame: After 1 months
measure: Zarit Burden Interview (ZBI)
timeFrame: After 1 months
measure: Hand-Grip Strenght Test
timeFrame: After 2 months
measure: 30 seconds sit-to stand test
timeFrame: After 2 months
measure: Ad-hoc semi-structured interviews aimed at the dyad
timeFrame: After 2 months
measure: Ad hoc semi-structured interviews with nurses and physiotherapists
timeFrame: After 2 months
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Loredana Buonaccorso
state: Emilia Romagna
Study officials:
affiliation: Psycho-Oncology Unit, Azienda USL - IRCSS Reggio Emilia
name: Loredana Buonaccorso, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buonaccorso L, Bertocchi E, Autelitano C, Allisen Accogli M, Denti M, Fugazzaro S, Martucci G, Costi S, Tanzi S. Psychoeducational and rehabilitative intervention to manage cancer cachexia (PRICC) for patients and their caregivers: protocol for a single-arm feasibility trial. BMJ Open. 2021 Mar 1;11(3):e042883. doi: 10.1136/bmjopen-2020-042883.
citation: Buonaccorso L, Fugazzaro S, Autelitano C, Bertocchi E, Accogli MA, Denti M, Costi S, Martucci G, Braglia L, Bassi MC, Tanzi S. Psycho-Educational and Rehabilitative Intervention to Manage Cancer Cachexia (PRICC) for Advanced Patients and Their Caregivers: Lessons Learned from a Single-Arm Feasibility Trial. Cancers (Basel). 2023 Mar 30;15(7):2063. doi: 10.3390/cancers15072063.