Patient-centred innovationDifferential adherence to peer and nurse components of a supportive care package—The appeal of peer support may be related to women’s health and psychological status
Introduction
Eysenbach argues that attrition is a natural and typical feature of eHealth (or digit health) trials and that determinants of attrition should be highlighted, measured, analysed, and discussed, including analysis and reporting of the characteristics of those who do and do not receive the intervention as designed; this includes intervention non-adherence, or non-usage attrition [1]. While comparatively lower overall, intervention non-adherence is also a fairly standard feature of non-eHealth trials of non-pharmacologic treatments like face-to-face psychological and behavioural interventions [2].
Standard guidelines for the reporting of such trials require fairly detailed reporting on the flow of participants through each stage of the trial, but reporting on factors associated with intervention non-adherence is not required [3], [4]. Here, non-adherence refers to instances where participants do not use the intervention as designed [1]. Understanding non-adherence is particularly valuable because it provides insight into the characteristics of patients who do not have the capacity or motivation to engage with or commit to the intervention being trialled. Stated another way, it speaks to the clinical utility [5] or accessibility [6] of an intervention; namely, its acceptability and appropriateness. It may also help to better understand the robustness of study results, including their generalisability and any assessment of intervention efficacy [7], [8].
Rigorous research on factors associated with non-adherence to complex non-pharmacologic interventions in cancer is lacking. A recent scoping review identified 21 studies with information relevant to adherence to, or ongoing use of, psychological interventions. Most, however, could only reasonably be classified as pilot studies and few, if any, included women diagnosed with gynaecological cancers [9]. Notwithstanding its limitations, this scoping review developed a useful taxonomy of factors that may be associated with patients’ decision to commit to non-pharmacologic interventions. These included participants’ socio-demographic characteristics (e.g. age and social support); participants’ health and wellbeing (e.g. their psychological and physical condition); the perceived value and utility of the intervention; and other characteristics of the intervention (e.g. logistical problems and temporal organisation).
We used data from the PeNTAGOn study—a randomised controlled trial (RCT) of a nurse- and peer-led support programme for women undergoing radiotherapy for gynaecological cancer [10]—to examine differences between complete and incomplete adherers to the nurse consultations and peer support sessions. Variables examined included socio-demographic and clinical characteristics, as well as patients’ self-reported health and wellbeing pre-radiotherapy.
Section snippets
Methods
This study comprises a sub-analysis of adherence data from the PeNTAGOn study (Trial registration: Australian New Zealand Clinical Trial Registry ACTRN12611000744954). PeNTAGOn was conducted at six sites in four Australian states and received ethical approval from relevant committees in each state. The published protocol provides a detailed description of trial methods and procedures [11].
Adherence
Of the 318 women randomised, 158 were assigned to the intervention arm (11 were scheduled to receive brachytherapy, so were only required to attend three intervention sessions). Out of 158 women, 112 participated in all available nurse sessions (71%, 95% confidence interval [CI]: 63 to 77), 30 participated in all but one available nurse session (19%, 95% CI: 14 to 26). Nine women participated in two sessions, one in one session and six in no nurse sessions. In total, 9 women missed the first
Discussion
Overall adherence to the specialist nurse consultations was satisfactory (all sessions: 71%; all but one session: 19%). High levels of engagement and sustained interest in the nurse sessions suggests that the content and method of delivery were acceptable and appropriate [2]. Adherence to the telephone peer support sessions, on the other hand, was less satisfactory (all sessions: 47%; all but one session: 24%). In this case, the peer component of our novel support package was less broadly
Funding
This project was funded by grants from Cancer Australia/Beyond Blue; Grant number: 566942, and the National Health and Medical Research Council; Grant Project number: GNT1005708. The funding bodies have had no role in the design of this study, nor in the collection, analysis and interpretation of data, or writing of this manuscript.
Ethics approval and consent to participate
Ethical approval was obtained from the Human Research Ethics Committees of participating states (Peter MacCallum Cancer Centre Ethics Committee, Project No: 09/07; Ethics Review Committee Royal Prince Alfred Zone, Project No: X11-0112 & HREC/11/RPAH/154; Royal Brisbane & Women’s Hospital Human Research Ethics Committee, Ref No: HREC/11/QRBW/202). All participants provided informed consent.
Consent for publication
Not applicable.
Author contributions
PS obtained study funding. PS and KG were involved in the design of the RCT. RB was involved in data management and collection for the RCT. All authors were involved in the design of the adherence sub-analysis; KG and AD analysed and interpreted the data. MP was a major contributor in writing the manuscript. All authors read, edited and approved the final manuscript.
Acknowledgements
We would like to acknowledge and thank the PeNTAGON study data managers and clinical investigators at participating sites in Victoria (Peter MacCallum Cancer Centre), Tasmania (Launceston General Hospital), NSW (Westmead Hospital, Prince of Wales and Royal Hospital for Women, Royal Prince Alfred Hospital), and Qld (Royal Brisbane and Women’s Hospital, Princess Alexandra Hospital/Radiation Oncology Mater). We also thank the Cancer Council Victoria and NSW staff who assisted in training peer
References (29)
- et al.
CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials
Int J Surg
(2012) - et al.
Attrition from self-directed interventions: investigating the relationship between psychological predictors, intervention content and dropout from a body dissatisfaction intervention
Soc Sci Med
(2010) - et al.
A nurse- and peer-led psycho-educational intervention to support women with gynaecological cancers receiving curative radiotherapy: the PeNTAGOn randomised controlled trial
Gynaecol Oncol
(2020) The new FIGO staging system for cancers of the vulva, cervix, endometrium and sarcomas
Gynecol Oncol
(2009)- et al.
Meta-analysis provides evidence-based effect sizes for a cancer-specific quality-of-life questionnaire, the FACT-G
J Clin Epidemiol
(2010) - et al.
Adjusting for multiple testing—when and how?
J Clin Epidemiol
(2001) The law of attrition
J Med Internet Res
(2005)- et al.
Psychological intervention targeting distress for cancer patients: a meta-analytic study investigating uptake and adherence
Psychooncology
(2016) - et al.
Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration
Ann Intern Med
(2008) A multi-dimensional model of clinical utility
Int J Qual Health Care
(2006)
Patient-centred access to health care: conceptualising access at the interface of health systems and populations
Int J Equity Health
Adherence in internet interventions for anxiety and depression
J Med Internet Res
Cancer patients’ participation and commitment to psychological interventions: a scoping review
Psychol Health
A nurse-and peer-led support program to assist women in gynaecological oncology receiving curative radiotherapy, the PeNTAGOn study (peer and nurse support trial to assist women in gynaecological oncology): study protocol for a randomised controlled trial
Trials
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These authors contributed equally to this paper; listing is alphabetical.