Cancer CachexiaNCT04153019
PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR CANCER CACHEXIA (PRICC)
A study testing Psychoeducational and rehabilitative intervention in people with Cancer Cachexia, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- Psychoeducational and rehabilitative intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer Cachexia
- Being tested
- Psychoeducational and rehabilitative intervention
- Keywords
- cancer cachexia, psychoeducational intervention, rehabilitative intervention, dyad, palliative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational and rehabilitative interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Psychoeducational and rehabilitative intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 2 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Mar 2019
- Primary completion1 Mar 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Loredana Buonaccorso, Dr., Principal investigator, Psycho-Oncology Unit, Azienda USL - IRCSS Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153019
- Sponsor's protocol ID
- AziendaUSLRE
- Status last verified
- Oct 2023
- First submitted
- 4 Nov 2019
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33649057Buonaccorso 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.
PubMed 37046724
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR THE ONCOLOGICAL PATIENT WITH CACHEXIA AND HIS CAREGIVER: A FEASIBILITY STUDY
- ClinicalTrials.gov ID
- NCT04153019
- Acronym / sponsor ID
- AziendaUSLRE
- Conditions
- Cancer Cachexia
- Keywords
- cancer cachexia, psychoeducational intervention, rehabilitative intervention, dyad, palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer cachexia | Other | Other: Psychoeducational and rehabilitative interventionPsycho-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational and rehabilitative interventionPsycho-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. | Other | Cancer cachexia |
Primary outcome
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.
6 secondary outcomes
Functional Assessment of Anorexia-Cachexia Therapy (FAACT)
Time frame: After 1 months
Zarit Burden Interview (ZBI)
Time frame: After 1 months
Hand-Grip Strenght Test
Time frame: After 2 months
30 seconds sit-to stand test
Time frame: After 2 months
Ad-hoc semi-structured interviews aimed at the dyad
Time frame: After 2 months
Ad hoc semi-structured interviews with nurses and physiotherapists
Time frame: After 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Results publication: PubMed 33649057Buonaccorso 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.
- Results publication: PubMed 37046724Buonaccorso 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.
- Psychoeducational and rehabilitative intervention to manage cancer cachexia (PRICC) for patients and their caregivers: protocol for a single-arm feasibility trialLink provided by the sponsor.
- Psycho-Educational and Rehabilitative Intervention to Manage Cancer Cachexia (PRICC) for Advanced Patients and Their Caregivers: Lessons Learned from a Single-Arm Feasibility TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cancer Cachexia
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Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
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Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
RecruitingPhase 2/3
Visugromab in Cachexia International Trial
Cancer-associated Cachexia
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loredana Buonaccorso, Dr. principal investigator
Psycho-Oncology Unit, Azienda USL - IRCSS Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational and rehabilitative intervention in people with Cancer Cachexia, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: After 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04153019, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.