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

Loredana Buonaccorso, Elisabetta Bertocchi, Cristina Autelitano, Monia Allisen Accogli, Monica Denti, Stefania Fugazzaro, Gianfranco Martucci, Stefania Costi, Silvia Tanzi, Loredana Buonaccorso, Elisabetta Bertocchi, Cristina Autelitano, Monia Allisen Accogli, Monica Denti, Stefania Fugazzaro, Gianfranco Martucci, Stefania Costi, Silvia Tanzi

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.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Timeline of the intervention.

References

    1. Hopkinson JB, Wright DNM, McDonald JW, et al. . The prevalence of concern about weight loss and change in eating habits in people with advanced cancer. J Pain Symptom Manage 2006;32:322–31.10.1016/j.jpainsymman.2006.05.012
    1. von Haehling S, Anker SD. Cachexia as a major underestimated and unmet medical need: facts and numbers. J Cachexia Sarcopenia Muscle 2010;1:1–5.10.1007/s13539-010-0002-6
    1. Arends J, Bachmann P, Baracos V, et al. . ESPEN guidelines on nutrition in cancer patients. Clin Nutr 2017;36:11–48.10.1016/j.clnu.2016.07.015
    1. Cederholm T, Barazzoni R, Austin P, et al. . ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr 2017;36:49–64.10.1016/j.clnu.2016.09.004
    1. Fearon K, Strasser F, Anker SD, et al. . Definition and classification of cancer cachexia: an international consensus. Lancet Oncol 2011;12:489–95.10.1016/S1470-2045(10)70218-7
    1. Maddocks M, Hopkinson J, Conibear J, et al. . Practical multimodal care for cancer cachexia. Curr Opin Support Palliat Care 2016;10:298–305.10.1097/SPC.0000000000000241
    1. Hui D, Dev R, Bruera E. The last days of life: symptom burden and impact on nutrition and hydration in cancer patients. Curr Opin Support Palliat Care 2015;9:346–54.10.1097/SPC.0000000000000171
    1. Bruera E, Hui D. Palliative care research: lessons learned by our team over the last 25 years. Palliat Med 2013;27:939–51.10.1177/0269216313477177
    1. Maddocks M, Murton AJ, Wilcock A. Therapeutic exercise in cancer cachexia. Crit Rev Oncog 2012;17:285–92.10.1615/CritRevOncog.v17.i3.60
    1. Maddocks M, Jones LW, Wilcock A. Immunological and hormonal effects of exercise: implications for cancer cachexia. Curr Opin Support Palliat Care 2013;7:376–82.10.1097/SPC.0000000000000010
    1. Grande AJ, Silva V, Riera R, et al. . Exercise for cancer cachexia in adults. Cochrane Database Syst Rev 2014:CD010804. 10.1002/14651858.CD010804.pub2
    1. Cheville AL, Girardi J, Clark MM, et al. . Therapeutic exercise during outpatient radiation therapy for advanced cancer: feasibility and impact on physical well-being. Am J Phys Med Rehabil 2010;89:611–9.10.1097/PHM.0b013e3181d3e782
    1. Oldervoll LM, Loge JH, Lydersen S, et al. . Physical exercise for cancer patients with advanced disease: a randomized controlled trial. Oncologist 2011;16:1649–57.10.1634/theoncologist.2011-0133
    1. Solheim TS, Laird BJA, Balstad TR, et al. . A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer. J Cachexia Sarcopenia Muscle 2017;8:778–88.10.1002/jcsm.12201
    1. Hagmann C, Cramer A, Kestenbaum A, et al. . Evidence-based palliative care approaches to non-pain physical symptom management in cancer patients. Semin Oncol Nurs 2018;34:227–40.10.1016/j.soncn.2018.06.004
    1. Reid J, McKenna H, Fitzsimons D, et al. . The experience of cancer cachexia: a qualitative study of advanced cancer patients and their family members. Int J Nurs Stud 2009;46:606–16.10.1016/j.ijnurstu.2008.10.012
    1. Amano K, Maeda I, Morita T, et al. . Eating-related distress and need for nutritional support of families of advanced cancer patients: a nationwide survey of bereaved family members. J Cachexia Sarcopenia Muscle 2016;7:527–34.10.1002/jcsm.12102
    1. Reid J, McKenna H, Fitzsimons D, et al. . Fighting over food: patient and family understanding of cancer cachexia. Oncol Nurs Forum 2009;36:439–45.10.1188/09.ONF.439-445
    1. Oberholzer R, Hopkinson JB, Baumann K, et al. . Psychosocial effects of cancer cachexia: a systematic literature search and qualitative analysis. J Pain Symptom Manage 2013;46:77–95.10.1016/j.jpainsymman.2012.06.020
    1. Hopkinson JB. Psychosocial impact of cancer cachexia. J Cachexia Sarcopenia Muscle 2014;5:89–94.10.1007/s13539-014-0142-1
    1. Reid J, McKenna HP, Fitzsimons D, et al. . An exploration of the experience of cancer cachexia: what patients and their families want from healthcare professionals. Eur J Cancer Care 2010;19:682–9.10.1111/j.1365-2354.2009.01124.x
    1. Lövgren M, Tishelman C, Sprangers M, et al. . Symptoms and problems with functioning among women and men with inoperable lung cancer--a longitudinal study. Lung Cancer 2008;60:113–24.10.1016/j.lungcan.2007.09.015
    1. Hopkinson JB, Fenlon DR, Okamoto I, et al. . The deliverability, acceptability, and perceived effect of the Macmillan approach to weight loss and eating difficulties: a phase II, cluster-randomized, exploratory trial of a psychosocial intervention for weight- and eating-related distress in people with advanced cancer. J Pain Symptom Manage 2010;40:684–95.10.1016/j.jpainsymman.2010.02.015
    1. Hopkinson JB, Fenlon DR, Foster CL. Outcomes of a nurse-delivered psychosocial intervention for weight- and eating-related distress in family carers of patients with advanced cancer. Int J Palliat Nurs 2013;19:116–23.10.12968/ijpn.2013.19.3.116
    1. Hopkinson JB, Richardson A. A mixed-methods qualitative research study to develop a complex intervention for weight loss and anorexia in advanced cancer: the family approach to weight and eating. Palliat Med 2015;29:164–76.10.1177/0269216314556924
    1. Kissane DW, Zaider TI, Li Y, et al. . Randomized controlled trial of family therapy in advanced cancer continued into bereavement. J Clin Oncol 2016;34:1921–7.10.1200/JCO.2015.63.0582
    1. Schuler TA, Zaider TI, Li Y, et al. . Typology of perceived family functioning in an American sample of patients with advanced cancer. J Pain Symptom Manage 2014;48:281–8.10.1016/j.jpainsymman.2013.09.013
    1. Kissane DW. The challenge of family-centered care in palliative medicine. Ann Palliat Med 2016;5:319–21.10.21037/apm.2016.08.04
    1. Margola D, Fenaroli V S, et al. . The family relationships index (FRI): multilevel confirmatory factor analysis in an Italian community sample. Eur J Psychol Assess 2019;35:335–45.
    1. Ribaudo JM, Cella D, Hahn EA, et al. . Re-validation and shortening of the functional assessment of anorexia/cachexia therapy (FAACT) questionnaire. Qual Life Res 2000;9:1137–46.10.1023/A:1016670403148
    1. The quality of life and nutrition in the patient with cancer by William Small J, M.D.; Robert Carrara, R.D.; Lynn Danford, M.S., L.D.; Jeri A. Logemann, Ph.D.; and David Cella, Ph.D. ACCC’s Integrating nutrition into your cancer program 2002:15–16.
    1. Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist 1980;20:649–55.10.1093/geront/20.6.649
    1. Chattat R, Cortesi V, Izzicupo F, et al. . The Italian version of the Zarit burden interview: a validation study. Int Psychogeriatr 2011;23:797–805.10.1017/S1041610210002218
    1. Shirley Ryan AbilityLab . Hand-held dynamometer/grip strength., 2014. Available: [Accessed 22 Jan 2019].
    1. Shirley Ryan AbilityLab . 30 second sit to stand test, 2013. Available: [Accessed 22 Jan 2019].
    1. Taylor M. Interviewing. : Holloway I, . Qualitative research in health care. Maidenhead, England: McGraw-Hill Education, 2005: 39–55.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3:77–101.10.1191/1478088706qp063oa

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner