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Clinical Trial
. 2021 Mar 1;11(3):e042883.
doi: 10.1136/bmjopen-2020-042883.

Psychoeducational and rehabilitative intervention to manage cancer cachexia (PRICC) for patients and their caregivers: protocol for a single-arm feasibility trial

Loredana Buonaccorso  1 , Elisabetta Bertocchi  2 , Cristina Autelitano  2 , Monia Allisen Accogli  3 , Monica Denti  3 , Stefania Fugazzaro  3 , Gianfranco Martucci  2 , Stefania Costi  4   5 , Silvia Tanzi  2   6
Affiliations
Clinical Trial

Psychoeducational and rehabilitative intervention to manage cancer cachexia (PRICC) for patients and their caregivers: protocol for a single-arm feasibility trial

Loredana Buonaccorso et al. BMJ Open. .

Abstract

Introduction: Half of all patients with cancer experience cachexia, with the prevalence rising above 80% in the last weeks of life. Cancer cachexia (CC) is a complex relational experience that involves the patient-family dyad. There are no studies on the association between the psychoeducational component and the rehabilitative component of dyads for supporting more functional relationships in the management of CC.The primary objective of this study is to evaluate the feasibility of a psychoeducational intervention combined with a rehabilitative intervention on dyads.The secondary objective is to improve the quality of life (QoL) and acceptability of the intervention.

Methods and analysis: This mixed-methods study with a nonpharmacological interventional prospective includes 30 consecutive cancer patients with cachexia and refractory cachexia and their caregivers, assisted by the Specialised Palliative Care Team. The recruitment will last 1 year. The intervention involves two components: (1) psychoeducational intervention: 3 weekly face-to-face consultations between dyads and trained nurses to help the dyads cope with involuntary weight loss and strengthening dyadic coping resources and (2) rehabilitation intervention: 3 biweekly educational sessions between dyads and trained physiotherapists focused on self-management, goal-setting, physical activity with three home exercise sessions per week.The primary endpoint will be in adherence to the intervention, indicated by a level of completion greater than or equal to 50% in both components. The secondary endpoints will be QoL (Functional Assessment of Anorexia-Cachexia Therapy), caregiver burden (Zarit Burden), physical performance (Hand-Grip strength and 30 seconds sit-to-stand test), and the acceptability of the intervention (ad hoc semi-structured interviews with the dyads and the healthcare professionals).

Ethics and dissemination: The study was approved by the Ethics Committee Area Vasta Emilia Nord, Azienda USL-IRCSS Reggio Emilia, Italy, number: 73/2019/SPER/IRCCSRE. The authors will provide the dissemination of the results through publication in international scientific journals.

Trial registration number: NCT04153019.

Keywords: adult oncology; adult palliative care; cancer cachexia; dyad; palliative care; psychoeducational intervention; qualitative research; rehabilitation; rehabilitation medicine.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Timeline of the intervention.
See this image and copyright information in PMC

References

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