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

Not Applicable

Completed

• Conditions: Cancer Cachexia
• Interventions: Other: Psychoeducational and rehabilitative intervention

• Registration Number: NCT04153019
• Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Primary Completion: 2021-03-01
• Study Completion: 2021-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cancer cachexia	Psychoeducational and rehabilitative intervention	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	After 2 months	The proportion of number of dyads who completed the intervention / involved dyads will be evaluated. Compliance will be assessed for each individual component (psycho-social and rehabilitative intervention). The overall intervention will be evaluated feasible if there is compliance greater than or equal to 50 percent to both interventions.

Secondary Outcome Measures

Name	Time	Method
Hand-Grip Strenght Test	After 2 months	Measurement of isometric muscle strength of the patient's upper limbs. The best out of three attempts is accounted for.
30 seconds sit-to stand test	After 2 months	Evaluation of functionally the strength of the lower limbs. The test counts the number of times the patient can get up from a chair without arms within a period of 30 second.
Ad hoc semi-structured interviews with nurses and physiotherapists	After 2 months	Qualitative evaluation of the perception of the benefits or difficulties during the intervention.
Functional Assessment of Anorexia-Cachexia Therapy (FAACT)	After 1 months	Evaluation of anorexia-cachexia related distress. Each item is scored 0-4 (0=Not at all; 4= Very much). Higher scores indicating greater quality of life.
Zarit Burden Interview (ZBI)	After 1 months	Measurement of the caregiver's perceived burden of providing family. Each item is scored 0-4 (0=Never; 4=Nearly always). Total score ranging: 0-88. Higher scores indicating greater burden.
Ad-hoc semi-structured interviews aimed at the dyad	After 2 months	Qualitative evaluation of the perception of the benefits, good adherence to the intervention or difficulties.

Trial Locations

Locations (1)

Loredana Buonaccorso; 🇮🇹 Reggio Emilia, Emilia Romagna, Italy