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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04153019
Recruitment Status : Unknown
Verified November 2019 by Loredana Buonaccorso, Azienda Unità Sanitaria Locale Reggio Emilia.
Recruitment status was:  Recruiting
First Posted : November 6, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Loredana Buonaccorso, Azienda Unità Sanitaria Locale Reggio Emilia

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.


Condition or disease Intervention/treatment Phase
Cancer Cachexia Other: Psychoeducational and rehabilitative intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR THE ONCOLOGICAL PATIENT WITH CACHEXIA AND HIS CAREGIVER: A FEASIBILITY STUDY
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cancer cachexia
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
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153019


Contacts
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Contact: Loredana Buonaccorso, Dr. + 39 3395655250 loredana.buonaccorso@ausl.re.it
Contact: Silvia Tanzi, Dr. +39 0522 295325 silvia.tanzi@ausl.re.it

Locations
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Italy
Loredana Buonaccorso Recruiting
Reggio Emilia, Emilia Romagna, Italy, 42100
Contact: Loredana Buonaccorso, Dr.    + 39 3395655250    loredana.buonaccorso@ausl.re.it   
Contact: Silvia Tanzi, Dr.    + 39 0522 295325    silvia.tanzi@ausl.re.it   
Sponsors and Collaborators
Azienda Unità Sanitaria Locale Reggio Emilia
Investigators
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Principal Investigator: Loredana Buonaccorso, Dr. Psycho-Oncology Unit, Azienda USL - IRCSS Reggio Emilia
  Study Documents (Full-Text)

Documents provided by Loredana Buonaccorso, Azienda Unità Sanitaria Locale Reggio Emilia:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Loredana Buonaccorso, Principal Investigator, Psychologist Psychotherapist, Psycho-Oncology Unit, Azienda USL - IRCSS Reggio Emilia, Azienda Unità Sanitaria Locale Reggio Emilia
ClinicalTrials.gov Identifier: NCT04153019    
Other Study ID Numbers: AziendaUSLRE
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Loredana Buonaccorso, Azienda Unità Sanitaria Locale Reggio Emilia:
cancer cachexia
psychoeducational intervention
rehabilitative intervention
dyad
palliative care
Additional relevant MeSH terms:
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Wasting Syndrome
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders