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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer Cachexia
• Intervention / Treatment: Other: Psychoeducational and rehabilitative intervention

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Loredana Buonaccorso, Dr.; Phone Number: + 39 3395655250; Email: loredana.buonaccorso@ausl.re.it
• Study Contact Backup: Name: Silvia Tanzi, Dr.; Phone Number: +39 0522 295325; Email: silvia.tanzi@ausl.re.it

Study Locations

• Italy
  • Emilia Romagna
    • Reggio Emilia, Emilia Romagna, Italy, 42100
      • Loredana Buonaccorso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Cancer cachexia; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia
• Investigators: Principal Investigator: Loredana Buonaccorso, Dr., Psycho-Oncology Unit, Azienda USL - IRCSS Reggio Emilia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: palliative care; psychoeducational intervention; dyad; cancer cachexia; rehabilitative intervention
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Thinness; Wasting Syndrome; Cachexia
• Other Study ID Numbers: AziendaUSLRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No