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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychoeducational and rehabilitative intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 1 months |
| Zarit Burden Interview (ZBI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loredana Buonaccorso, Dr. | Psycho-Oncology Unit, Azienda USL - IRCSS Reggio Emilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loredana Buonaccorso | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33649057 | Result | 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. | |
| 37046724 |
| Label | URL |
|---|---|
| Psychoeducational and rehabilitative intervention to manage cancer cachexia (PRICC) for patients and their caregivers: protocol for a single-arm feasibility trial | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2019 | Nov 4, 2019 | Prot_SAP_000.pdf |
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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. |
| 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. | 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. | 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. | 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. | After 2 months |
| Buonaccorso 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. |