Introduction

Social determinants of health (SDoH; eg, housing, neighbourhood and physical environment, safety) are key drivers of health and well-being.1 SDoH are reinforced at the policy level, downstream of which are the unmet social needs experienced by individuals, factors such as housing and financial stress, food insecurity and social isolation.1 2 COVID-19, ageing populations and the shift in global burden of disease to chronic illness have created momentum for many countries to include action on unmet social needs as a health policy priority.3

Across the USA, the UK and Europe, healthcare systems are trialling Health Navigator (HN) interventions in healthcare settings to address the unmet social needs of disadvantaged populations.3–6 HN interventions typically comprise three steps: (1) screening for unmet social needs in a healthcare setting using a dedicated screening tool for unmet social needs; (2) linking patients reporting unmet social needs to HNs, who provide appropriate government and community resources; and (3) ongoing follow-up in the community. HNs assist patients with connections to resources and provide extensive advocacy and psychosocial support throughout follow-up in the community.5 7

Populations living with cancer face substantial financial and employment instability as treatment requires protected contact with the healthcare system, and adverse treatment effects can reduce earning capacity.8 While care navigation is an established intervention in the cancer context, beginning in Harlem cancer clinics in the 1990s,9 HN interventions that seek to address the unmet social needs of populations living with cancer are less well-defined. Most studies assess singular social needs, for example, ‘financial toxicity,’10 food insecurity or lack of access to transportation.11 As in other disease populations, evidence of the benefit of HN interventions is mixed4 11 12 due to heterogeneity in study design and study outcomes.4 12 Some question the appropriateness of HN interventions in the cancer setting, as one study reports as little as 23% of participants reporting unmet social needs requested assistance from a HN.13 Furthermore, HN training, role descriptions and follow-up durations vary substantially across different settings,5 rendering the feasibility of integrating HN interventions in healthcare settings unclear.

In Australia, one in four cancer patients pays more than $AUD 10 000 out-of-pocket costs every 2 years,14 creating substantial financial pressure on patients and carers alike.15 To our knowledge, HN interventions to address the unmet social needs of patients in Australia are limited. Here, we present a protocol for a pilot study examining the feasibility and acceptability of an HN intervention to address the unmet social needs of populations accessing cancer care in an Australian healthcare setting.

Aims and objectives

The primary aim of this study is to examine the feasibility and acceptability of integrating a HN intervention in an Australian outpatient setting serving a population living with cancer. We will assess feasibility through rates of recruitment, intervention uptake and intervention completion. Acceptability will be assessed through focus groups and brief surveys with clinicians and participants. Our secondary aim is to explore the impact of the HN intervention on participants’ experience of care, quality of life and ability to cope with cancer. The primary objective of the study is to evaluate and optimise the HN research process, including data collection and maintenance, and to refine intervention procedures and outcome measures for future studies.

Methods and analysisSetting

The study will be conducted in one outpatient cancer clinic that serves the most disadvantaged urban population in South Australia.16 Previous research in this population suggests that social risks such as financial instability, food and housing insecurity are highly prevalent.17 Clinicians frequently report patients undergoing chemotherapy living in their cars or missing treatments to work unstable jobs.

The study is planned to commence 8 August 2022 and complete 29 February 2024.

Participants and sample size

Inclusion criteria are:

Able to provide written, informed consent in English.

Adults ≥18 years old with any cancer diagnosis.

Receiving cancer care or follow-up at the Northern Adelaide Cancer Centre.

Exclusion criteria are:

Patients were deemed by the Principal Investigator to not be capable of understanding or complying with study protocol requirements, based on clinical appraisal of patients’ capacity to take part in informed decision-making. Participants experiencing mental health crisis, for example, suicidal ideation, severe depression and anxiety, or adverse treatment effects resulting in ongoing confusion and difficulties communicating with the HN, will be excluded.

Given the primary aim of assessing feasibility, there is no relevant power calculation. However, a previous trial of screening for social needs in the Northern Adelaide Cancer Centre (unpublished) without optional assistance from a HN reported a 60% recruitment rate. Based on an intervention period of 6 months and an eligible patient pool of 30 patients per week, a minimum 60% recruitment rate and allowing for approximately 15% loss to follow-up and 5% missingness, we anticipate a maximum sample of 350 participants.

Outcome measures

Our primary aim is to determine intervention feasibility and acceptability, which will be evaluated using:

Recruitment rates will be successful if 80% of eligible participants agree to complete screening for unmet social needs

Intervention uptake will be successful if 80% of participants who report unmet social needs consent to assistance from the HN.

Intervention completion will be successful if 80% of participants who request assistance from the HN complete the 6-month follow-up intervention period.

Reasons for non-participation and failure to complete the intervention

Brief questionnaires sent to all participants and clinicians to explore intervention feasibility and acceptability.

Focus groups with participants and clinicians to explore acceptability of the HN intervention.

Other feasibility studies exploring screening and referral for unmet social needs in non-cancer populations have used a threshold for success of 80–90%.18 We have chosen to lower our threshold to 80% to accommodate the adverse treatment effects19 and psychosocial complications populations living with cancer may experience.20

Our secondary aims include exploring how the HN intervention affects participants’ unmet social needs, as measured by the Unmet Needs Screening Tool (UNST). The UNST assesses seven key unmet social needs: housing, finances, food security, access to transport, employment, safety and social support (see online supplemental file 1). The UNST was co-designed with local community and clinicians and has demonstrated good face validity.21 We will also compare how participants’ ability to cope with cancer day-to-day, health-related quality of life and experience of care is impacted by the HN intervention, as measured by the Cancer Behaviour Inventory-Brief (CBI-B),22 Functional Assessment of Cancer Therapy (FACT-G)23 and Australian Hospital Patient Experience Questionnaire Set (AHPEQS)24 measures, respectively. The CBI-B and FACT-G both demonstrate strong concurrent validity with other well-validated health-related quality of life tools and good internal consistency in populations living with cancer.23 25 The AHPEQS is the Australian national generic measure of patient-reported experience measure, allowing for consistent measurement of core aspects of quality healthcare care in Australia.26

Study procedure

A researcher will approach eligible participants to obtain written, informed consent and conduct baseline clinical measures (FACT-G, CBI-C and AHPEQS) and screening for unmet social needs using the UNST. The researcher will collect participant contact and demographic details. We will ask eligible participants who decline participation reasons for their decision. Recruitment will take place over 6 months (see online supplemental file 2 for study process diagram).

If the participant has ≥1 unmet need and requests assistance, they will be referred to the HN. The researcher will arrange a time for the participant to meet with the HN for an initial meeting. Participants without any identified unmet needs will not be referred to the HN for intervention. During the initial HN meeting, the HN will work collaboratively with the participant to prioritise their three most important unmet needs (if they report more than one). This will inform the case management plan and referral to community-based resources. If the participant requires any assistance with contacting the appropriate community resource, the HN will help by making the phone call for them, organising their meeting time, organising transport to get to the meeting, and if requested, attend meetings with the participant. All these options, requests and case management plans will be recorded in the study database and will be provided to participants in hardcopy or via email for their own reference. All the information regarding community resources and appropriate contact details, including crisis support resources, will be given to the participant by the HN in an information pack. The HN will end the initial meeting once the participant has decided which service provider will be contacted first, the goal for meeting with the service, the timeframe for engaging with the service and their desired endpoint. Participants will be able to call the HN at any time during their work hours by study phone if they require assistance or clarification. The HN will arrange a time for follow-up at the participant’s convenience. Outside of working hours, there will be a message system that provides HN working hours and allows participants to leave their contact details for follow-up during working hours.

The first follow-up contact will be offered within 7–14 days of baseline assessment and approximately every 4 weeks thereafter until intervention completion at 6 months after baseline assessment, or participants decline further assistance. This follow-up schedule can be adjusted by the participant as preferred. At each follow-up contact point, the participant will notify the HN of progress towards resolving their unmet need(s). If their needs have been met, this will be classified as ‘resolved’, and the process will be repeated for other identified unmet needs. If more time is required with the same service this will be classified as ‘engaged’ and revisited in the next follow-up call. If the resource was not useful or unable to meet the participants’ needs, this will be classified as ‘failed’, and another resource will be identified by the HN to assist the participant. The HN will also ask participants why the referral was unsuccessful. Participants will be classified as ‘lost to follow-up’ if they can no longer be reached after three attempted contacts. These classifications and call attempts will be captured during each follow-up call. If participants are satisfied with the HN service or their unmet social needs are resolved prior to the 6-month intervention completion, this will be classified as ‘early intervention exit’ and participants will not be required to remain in follow-up (see online supplemental file 2 for study process diagram).

At the end of the intervention period, a researcher will administer repeat measures (UNST, CBI-B, FACT-G and AHPEQS) to all participants. Participants who took part in the HN intervention and clinicians will be asked to take part in separate focus groups to explore their views of the HN intervention, and barriers and enablers to screening for unmet social needs in the outpatient setting.

Data collection

Data will be collected and managed using the Research Electronic Data Capture (REDCap) tool hosted at the University of Adelaide. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages; and (4) procedures for data integration and interoperability with external sources.

Data analysis

Following the latest Medical Research Council guidelines,27 primary outcomes of intervention feasibility and acceptability will be assessed using mixed-methods. Intervention feasibility will be assessed using process measures, that is, rates of recruitment, intervention uptake and completion, and through brief quantitative surveys administered to clinicians (Feasibility and Acceptability Intervention Measures, see table 1). Intervention acceptability will be assessed using separate focus groups with clinicians and participants. Participants who received the HN intervention will be approached to take part in focus groups to explore their experience of the intervention. Focus group discussions will follow a semistructured interview guide exploring (1) causal mechanisms underlying resolution of social needs and other secondary outcomes, (2) strengths and limitations of the intervention, and (3) barriers and enablers to intervention uptake. Clinicians who engage with the HNs and research team will be approached to take part in focus groups exploring (1) clinician-HN referral workflows and (2) barriers and enablers to working with HNs in their clinical practice. Focus group audio will be recorded and transcribed for thematic analysis. While the concept of ‘data saturation’ is often proposed to justify sample size calculations in qualitative research, we support the view of methodologists that meaning resides not in the data but in the subjective interpretation of the researcher and that there will never be ‘no new’ information from further focus groups.28 We aim to conduct six focus groups, two with clinicians and four with participants, with a minimum of three participants in each group (semi-structured interview schedule available in online supplemental file 3).

Table 1

Summary of objectives, outcomes, criteria for success of feasibility and methods of analysis

Secondary outcomes, that is, intervention effects on participants’ unmet social needs and clinical measures, will be assessed quantitatively using pre-post changes in measures at study baseline and at follow-up completion. Changes in measures will be compared between groups with and without the HN intervention. If participant numbers are sufficient, we will conduct a secondary analysis of Indigenous populations’ social needs and experiences of the intervention.

All quantitative data will be analysed using descriptive statistics in STATA MP17 software. Qualitative data will be analysed using reflexive thematic analysis and NVivo 15 software. Criteria for feasibility success, outcomes and analyses are summarised in table 1.

Patient and public involvement

Participants were first involved in our research in the formulation and validation of the UNST. The screening tool was co-designed and qualitatively validated with participants from previous studies and clinicians working with the target population.21

A previous validation study in the target population informed our approach to administering the screening tool.29 The study determined that most participants preferred to complete the UNST individually, without assistance. In this study, we will offer participants the option to complete the screening tool alone, without involvement from a researcher.

In the future, we will use the experience of these participants to further refine the screening tool. We will use participants’ experiences with the HN to inform future study design, processes, and follow-up and refine the HN role for future implementation.

Ethics and dissemination

This trial has received ethical approval from the Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC ref: 16448) and the Northern Adelaide Local Health Network Research Governance Office (NALHN RGO ref: 22–069). Informed consent will be obtained from all participants (a copy of the patient information and consent form can be found in online supplemental file 4). The study will be conducted following Good Clinical Practice guidelines and recommendations for research involving human subjects adopted by 18th World Medical Assembly, Helsinki 1964 and subsequent revisions. Amendments to study protocol will be communicated by the Research Coordinator to all relevant parties and trial registries.

To ensure participant data confidentiality is maintained, the HNs will ask for consent to share participants’ contact details with appropriate community services and inform participants of their responsibility to report any circumstances which may endanger themselves or those around them. If there are concerns for participants’ safety or those around them, the HN will notify the Principal Investigator who will follow appropriate procedures. We expect the HN role to be challenging and will ensure specific measures are in place to address any concerns that may arise. This includes prioritising time every week for the HN to debrief about caseload, case severity and provide feedback regarding study processes. Study results will be disseminated to participants, clinicians and community service providers in the format of journal publications, conference presentations and lay summaries, as appropriate. All investigators will be listed as authors on publications.

Data governance

All identifiable data will be stored on password-protected servers belonging to the University of Adelaide or in locked filing cabinets to which only the Research Coordinator will have access. Due to the small, low-risk nature of this pilot study, a Data Monitoring Committee is not needed.