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

NCT04153019 | Completed DMC

• 1 other identifier: AziendaUSLRE
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Cachexia

Keywords

cancer cachexia; psychoeducational intervention; rehabilitative intervention; dyad; palliative care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Functional Assessment of Anorexia-Cachexia Therapy (FAACT)

  After 1 months

• Zarit Burden Interview (ZBI)

  After 1 months

• Hand-Grip Strenght Test

  After 2 months

• 30 seconds sit-to stand test

  After 2 months

• Ad-hoc semi-structured interviews aimed at the dyad

  After 2 months

Study Arms (1)

Cancer cachexia

OTHER

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

Interventions

Psychoeducational and rehabilitative intervention OTHER

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.

Cancer cachexia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Loredana Buonaccorso

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

Related Publications (2)

• 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.

  PMID: 33649057 RESULT

• 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.

  PMID: 37046724 RESULT

Related Links

• Psychoeducational and rehabilitative intervention to manage cancer cachexia (PRICC) for patients and their caregivers: protocol for a single-arm feasibility trial

Study Officials

• Loredana Buonaccorso, Dr.

  Psycho-Oncology Unit, Azienda USL - IRCSS Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: September 30, 2021
• Last Updated: June 12, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)