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

Primary Purpose

Cancer Cachexia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Psychoeducational and rehabilitative intervention
Sponsored by
Azienda Unità Sanitaria Locale Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Cachexia focused on measuring cancer cachexia, psychoeducational intervention, rehabilitative intervention, dyad, palliative care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Loredana Buonaccorso

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cancer cachexia

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Hand-Grip Strenght Test
Measurement of isometric muscle strength of the patient's upper limbs. The best out of three attempts is accounted for.
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.
Ad-hoc semi-structured interviews aimed at the dyad
Qualitative evaluation of the perception of the benefits, good adherence to the intervention or difficulties.
Ad hoc semi-structured interviews with nurses and physiotherapists
Qualitative evaluation of the perception of the benefits or difficulties during the intervention.

Full Information

First Posted
November 4, 2019
Last Updated
October 9, 2023
Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia
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1. Study Identification

Unique Protocol Identification Number
NCT04153019
Brief Title
PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR CANCER CACHEXIA (PRICC)
Official Title
PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR THE ONCOLOGICAL PATIENT WITH CACHEXIA AND HIS CAREGIVER: A FEASIBILITY STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Cachexia
Keywords
cancer cachexia, psychoeducational intervention, rehabilitative intervention, dyad, palliative care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cancer cachexia
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Psychoeducational and rehabilitative intervention
Intervention Description
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 Measure Information:
Title
Feasibility of the intervention
Description
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.
Time Frame
After 2 months
Secondary Outcome Measure Information:
Title
Functional Assessment of Anorexia-Cachexia Therapy (FAACT)
Description
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.
Time Frame
After 1 months
Title
Zarit Burden Interview (ZBI)
Description
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.
Time Frame
After 1 months
Title
Hand-Grip Strenght Test
Description
Measurement of isometric muscle strength of the patient's upper limbs. The best out of three attempts is accounted for.
Time Frame
After 2 months
Title
30 seconds sit-to stand test
Description
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.
Time Frame
After 2 months
Title
Ad-hoc semi-structured interviews aimed at the dyad
Description
Qualitative evaluation of the perception of the benefits, good adherence to the intervention or difficulties.
Time Frame
After 2 months
Title
Ad hoc semi-structured interviews with nurses and physiotherapists
Description
Qualitative evaluation of the perception of the benefits or difficulties during the intervention.
Time Frame
After 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loredana Buonaccorso, Dr.
Organizational Affiliation
Psycho-Oncology Unit, Azienda USL - IRCSS Reggio Emilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loredana Buonaccorso
City
Reggio Emilia
State/Province
Emilia Romagna
ZIP/Postal Code
42100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33649057
Citation
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.
Results Reference
derived

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

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