PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR THE ONCOLOGICAL PATIENT WITH CACHEXIA AND HIS CAREGIVER: A FEASIBILITY STUDY
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer Cachexia
- Sponsor
- Azienda USL Reggio Emilia - IRCCS
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Feasibility of the intervention
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Hand-Grip Strenght Test(After 2 months)
- 30 seconds sit-to stand test(After 2 months)
- Ad hoc semi-structured interviews with nurses and physiotherapists(After 2 months)
- Functional Assessment of Anorexia-Cachexia Therapy (FAACT)(After 1 months)
- Zarit Burden Interview (ZBI)(After 1 months)
- Ad-hoc semi-structured interviews aimed at the dyad(After 2 months)