Skip to main content
OpenTrials
Completed

NCT Number: NCT04153019

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Cachexia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loredana Buonaccorso

Reggio Emilia, Emilia-Romagna, 42100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of the intervention

    Time frame: 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 outcomes

  1. Functional Assessment of Anorexia-Cachexia Therapy (FAACT)

    Time frame: 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.

  2. Zarit Burden Interview (ZBI)

    Time frame: 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.

  3. Hand-Grip Strenght Test

    Time frame: After 2 months

    Measurement of isometric muscle strength of the patient's upper limbs. The best out of three attempts is accounted for.

  4. 30 seconds sit-to stand test

    Time frame: 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.

  5. Ad-hoc semi-structured interviews aimed at the dyad

    Time frame: After 2 months

    Qualitative evaluation of the perception of the benefits, good adherence to the intervention or difficulties.

  6. Ad hoc semi-structured interviews with nurses and physiotherapists

    Time frame: After 2 months

    Qualitative evaluation of the perception of the benefits or difficulties during the intervention.

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2019
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.