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

Cancer Cachexia Clinical Trial

Official title:

PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR THE ONCOLOGICAL PATIENT WITH CACHEXIA AND HIS CAREGIVER: A FEASIBILITY STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153019
• Other study ID #: AziendaUSLRE
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2023
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 30, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Cancer Cachexia

Intervention

Other:
• Psychoeducational and rehabilitative intervention
Psycho-educational session: 3 weekly face-to-face consultations between a dyads 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.

Locations

Country	Name	City	State
Italy	Loredana Buonaccorso	Reggio Emilia	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the intervention	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.	After 2 months
Secondary	Functional Assessment of Anorexia-Cachexia Therapy (FAACT)	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.	After 1 months
Secondary	Zarit Burden Interview (ZBI)	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.	After 1 months
Secondary	Hand-Grip Strenght Test	Measurement of isometric muscle strength of the patient's upper limbs. The best out of three attempts is accounted for.	After 2 months
Secondary	30 seconds sit-to stand test	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.	After 2 months
Secondary	Ad-hoc semi-structured interviews aimed at the dyad	Qualitative evaluation of the perception of the benefits, good adherence to the intervention or difficulties.	After 2 months
Secondary	Ad hoc semi-structured interviews with nurses and physiotherapists	Qualitative evaluation of the perception of the benefits or difficulties during the intervention.	After 2 months