Study protocol for a single-site feasibility study evaluating the adoption and fidelity of Prep-4-RT: prehabilitation for head and neck cancer patients undergoing radiotherapy.
Head and neck cancer
Multimodal
Nutrition and dietetics
Physiotherapy
Prehabilitation
Psychology
Radiotherapy
Speech pathology
Stepped-care
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
02 Aug 2024
02 Aug 2024
Historique:
received:
04
07
2023
accepted:
15
07
2024
medline:
3
8
2024
pubmed:
3
8
2024
entrez:
2
8
2024
Statut:
epublish
Résumé
Prep-4-RT is a co-designed stepped-care multimodal prehabilitation program for people scheduled to receive radiotherapy for head and neck cancer (HNC). Prehabilitation, which occurs between diagnosis and treatment commencement, aims to improve a patient's health to reduce the incidence and severity of current and future impairments. HNC treatment can be distressing and has detrimental impacts on function and quality of life. HNC patients have increased social vulnerabilities including higher rates of socio-economic disadvantage and engagement in lifestyle habits which increase cancer risk. High levels of physical and psychological impacts of HNC treatment and increased social vulnerabilities of this population warrant investigation of optimal pathways of care, such as prehabilitation. This paper describes a research protocol to evaluate the feasibility of Prep-4-RT, which was designed to prepare HNC patients for the physical and psychological impacts of radiotherapy. At least sixty adult HNC patients, scheduled to receive radiotherapy (with or without chemotherapy), will be recruited over a five-month period. All participants will receive access to Prep-4-RT self-management resources. Participants identified through screening as high-risk will also be offered individualised interventions with relevant allied health professionals prior to the commencement of radiotherapy (psychologists, dietitians, speech pathologists and physiotherapists). Participants will complete evaluation surveys assessing their experiences with Prep-4-RT resources and interventions. Clinicians will also complete program evaluation surveys. Primary feasibility outcomes include adoption (uptake and intention to try) and fidelity (adherence to the specialist prehabilitation pathway). Secondary feasibility outcomes include acceptability (patient and clinician) of and satisfaction (patient) with Prep-4-RT as well as operational costs. Feasibility outcome data will be analysed using exact binomial and one-sample t tests, as appropriate. Ethics approval has been obtained at the Peter MacCallum Cancer Centre in Melbourne, Australia. Results will be presented at national conferences and published in peer-reviewed journal(s) so that it can be accessed by clinicians involved in the care of HNC patients receiving radiotherapy. If the model of care is found to be feasible and acceptable, the transferability and scalability to other cancer centres, or for other cancer types, may be investigated. ANZCTA (Australian New Zealand Clinical Trials Registry) ACTRN12623000770662.
Identifiants
pubmed: 39095879
doi: 10.1186/s40814-024-01531-2
pii: 10.1186/s40814-024-01531-2
doi:
Types de publication
Journal Article
Langues
eng
Pagination
106Informations de copyright
© 2024. The Author(s).
Références
Moschopoulou E, Hutchison I, Bhui K, Korszun A. Post-traumatic stress in head and neck cancer survivors and their partners. Support Care Cancer. 2018;26(9):3003–11.
doi: 10.1007/s00520-018-4146-9
pubmed: 29546528
Threader J, McCormack L. Cancer-related trauma, stigma and growth: the ‘lived’ experience of head and neck cancer. Eur J Cancer Care (Engl). 2016;25(1):157–69.
doi: 10.1111/ecc.12320
pubmed: 25899673
Capuano G, Gentile PC, Bianciardi F, Tosti M, Palladino A, Di Palma M. Prevalence and influence of malnutrition on quality of life and performance status in patients with locally advanced head and neck cancer before treatment. Support Care Cancer. 2010;18(4):433–7.
doi: 10.1007/s00520-009-0681-8
pubmed: 19562384
Findlay M, White K, Stapleton N, Bauer J. Is sarcopenia a predictor of prognosis for patients undergoing radiotherapy for head and neck cancer? A meta-analysis. Clin Nutr. 2021;40(4):1711–8.
doi: 10.1016/j.clnu.2020.09.017
pubmed: 32994071
Marshall KM, Loeliger J, Nolte L, Kelaart A, Kiss NK. Prevalence of malnutrition and impact on clinical outcomes in cancer services: a comparison of two time points. Clin Nutr. 2019;38(2):644–51.
doi: 10.1016/j.clnu.2018.04.007
pubmed: 29789167
Xu B, Boero IJ, Hwang L, Le QT, Moiseenko V, Sanghvi PR, et al. Aspiration pneumonia after concurrent chemoradiotherapy for head and neck cancer. Cancer. 2015;121(8):1303–11.
doi: 10.1002/cncr.29207
pubmed: 25537836
Alias A, Henry M. Psychosocial effects of head and neck cancer. Oral Maxillofac Surg Clin North Am. 2018;30(4):499–512.
doi: 10.1016/j.coms.2018.06.010
pubmed: 30266192
Dunne S, Mooney O, Coffey L, Sharp L, Desmond D, Timon C, et al. Psychological variables associated with quality of life following primary treatment for head and neck cancer: a systematic review of the literature from 2004 to 2015. Psychooncology. 2017;26(2):149–60.
doi: 10.1002/pon.4109
pubmed: 26918648
Kam D, Salib A, Gorgy G, Patel TD, Carniol ET, Eloy JA, et al. Incidence of suicide in patients with head and neck cancer. JAMA Otolaryngol Head Neck Surg. 2015;141(12):1075.
doi: 10.1001/jamaoto.2015.2480
pubmed: 26562764
McQuestion M, Fitch M, Howell D. The changed meaning of food: physical, social and emotional loss for patients having received radiation treatment for head and neck cancer. Eur J Oncol Nurs. 2011;15(2):145–51.
doi: 10.1016/j.ejon.2010.07.006
pubmed: 20864401
Badr H, Gupta V, Sikora A, Posner M. Psychological distress in patients and caregivers over the course of radiotherapy for head and neck Cancer. Oral Oncol. 2014;50(10):1005–11.
doi: 10.1016/j.oraloncology.2014.07.003
pubmed: 25091150
pmcid: 4165786
Daniell JR, Dolja-Gore X, McDowell L, Udovicich C, Rowe D, Iseli TA, et al. The impact of travel distance to treatment centre on oral tongue squamous cell carcinoma survival and recurrence. Int J Oral Maxillofac Surg. 2022;51(7):854–61.
doi: 10.1016/j.ijom.2021.08.026
pubmed: 34551874
Cancer Council Victoria and Department of Health Victoria. Optimal care pathway for people with head and neck cancer, second edition. Melbourne: Cancer Council Victoria; 2021.
MacMillan Cancer Support. Principles and guidance for prehabilitation within the management and support of people with cancer. 2017.
Silver JK, Baima J. Cancer Prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013;92(8):715–27.
doi: 10.1097/PHM.0b013e31829b4afe
pubmed: 23756434
Bolshinsky V, Li MHG, Ismail H, Burbury K, Riedel B, Heriot A. Multimodal prehabilitation programs as a bundle of care in gastrointestinal cancer surgery: a systematic review. Dis Colon Rectum. 2018;61(1):124–38.
doi: 10.1097/DCR.0000000000000987
pubmed: 29219922
Daniels SL, Lee MJ, George J, Kerr K, Moug S, Wilson TR, et al. Prehabilitation in elective abdominal cancer surgery in older patients: systematic review and meta-analysis. BJS Open. 2020;4(6):1022–41.
doi: 10.1002/bjs5.50347
pubmed: 32959532
pmcid: 7709363
Hijazi Y, Gondal U, Aziz O. A systematic review of prehabilitation programs in abdominal cancer surgery. Int J Surg. 2017;39:156–62.
doi: 10.1016/j.ijsu.2017.01.111
pubmed: 28161527
Carli F, Silver JK, Feldman LS, McKee A, Gilman S, Gillis C, et al. Surgical prehabilitation in patients with cancer: state-of-the-science and recommendations for future research from a panel of subject matter experts. Phys Med Rehabil Clin N Am. 2017;28(1):49–64.
doi: 10.1016/j.pmr.2016.09.002
pubmed: 27913000
Santa Mina D, van Rooijen SJ, Minnella EM, Alibhai SMH, Brahmbhatt P, Dalton SO, et al. Multiphasic prehabilitation across the cancer continuum: a narrative review and conceptual framework. Front Oncol. 2021;11:10.
Loewen I, Jeffery CC, Rieger J, Constantinescu G. Prehabilitation in head and neck cancer patients: a literature review. J Otolaryngol Head Neck Surg. 2021;50(1):2.
doi: 10.1186/s40463-020-00486-7
pubmed: 33407922
pmcid: 7789666
Waterland JL, McCourt O, Edbrooke L, Granger CL, Ismail H, Riedel B, et al. Efficacy of prehabilitation including exercise on postoperative outcomes following abdominal cancer surgery: a systematic review and meta-analysis. Front Surg. 2021;19:8.
MacMillan Cancer Support. Prehabilitation evidence and insight review. 2017.
Andrews G, Slade T. Interpreting scores on the Kessler Psychological Distress Scale (K10). Aust N Z J Public Health. 2001;25(6):494–7.
doi: 10.1111/j.1467-842X.2001.tb00310.x
pubmed: 11824981
Kessler RC, Barker PR, Colpe LJ, Epstein JF, Gfroerer JC, Hiripi E, et al. Screening for serious mental illness in the general population. Arch Gen Psychiatry. 2003;60(2):184.
doi: 10.1001/archpsyc.60.2.184
pubmed: 12578436
Ferguson M, Capra S, Bauer J, Banks M. Development of a valid and reliable malnutrition screening tool for adult acute hospital patients. Nutrition. 1999;15(6):458–64.
doi: 10.1016/S0899-9007(99)00084-2
pubmed: 10378201
Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013;14(8):531–2.
doi: 10.1016/j.jamda.2013.05.018
pubmed: 23810110
Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, et al. A brief self-administered questionnaire to determine functional capacity (The Duke Activity Status Index). Am J Cardiol. 1989;64(10):651–4.
doi: 10.1016/0002-9149(89)90496-7
pubmed: 2782256
Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, et al. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008;117(12):919–24.
doi: 10.1177/000348940811701210
pubmed: 19140539
Sekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022;22(1):279.
doi: 10.1186/s12913-022-07577-3
pubmed: 35232455
pmcid: 8887649
Attkisson CC, Zwick R. The client satisfaction questionnaire. Eval Program Plann. 1982;5(3):233–7.
doi: 10.1016/0149-7189(82)90074-X
pubmed: 10259963
Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot Feasib Stud. 2021;7(1):40.
doi: 10.1186/s40814-021-00770-x
R Core Team. A language and environment for statistical computing. Foundation for Statistical Computing. Vienna, Austria; 2021. Available from: https://www.R-project.org/ . Cited 2023 Jul 30.