PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR CANCER CACHEXIA (PRICC) (NCT04153019) | Clinical Trial Compass
CompletedNot Applicable
PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR CANCER CACHEXIA (PRICC)
Italy24 participantsStarted 2019-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.