PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR CANCER CACHEXIA (PRICC)

Azienda USL Reggio Emilia - IRCCS

Status: Completed

Conditions: Cancer Cachexia

Treatments: Other: Psychoeducational and rehabilitative intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04153019

AziendaUSLRE

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

Cancer cachexia

Other group

Description:

Psycho-educational session: 3 weekly face-to-face consultations between a dyads (patients-caregivers) and trained nurses, helping them to cope with cancer cachexia strengthening dyadic coping resources; 2) Rehabilitation program: 3 sessions with physiotherapists including educational component for patients self-management on physical activity and goal-setting, personalized program of exercises stretching and relaxation + 3 home sessions per week, self-managed by dyads.

Treatment:

Other: Psychoeducational and rehabilitative intervention