I-CoPE: A pilot study of structured supportive care delivery to people with newly diagnosed high-grade glioma and their carers

Abstract

Background

There is limited evidence to guide best approaches to supportive care delivery to patients with high-grade glioma. I-CoPE (Information, Coordination, Preparation and Emotional) is a structured supportive care approach for people with newly diagnosed high-grade glioma and their family carers. Delivered by a cancer care coordinator, I-CoPE consists of (1) staged information, (2) regular screening for needs, (3) communication and coordination, and (4) family carer engagement. This pilot study tested acceptability and preliminary effectiveness of I-CoPE, delivered over 3 transitions in the illness course, for people newly diagnosed with high-grade glioma and their carers.

Methods

I-CoPE was delivered at the identified transition times (at diagnosis, following the diagnostic hospitalization, following radiotherapy), with associated data collection (enrollment, 2 weeks, 12 weeks). Outcomes of interest included: acceptability/feasibility (primary); quality of life; needs for support; disease-related information needs; and carer preparedness to care (secondary). Descriptive statistics were used to assess acceptability outcomes, while patient and carer outcomes were assessed using repeated measures ANOVA.

Results

Thirty-two patients (53% male, mean age 60) and 31 carers (42% male) participated. I-CoPE was highly acceptable: 86% of eligible patients enrolled, and of these 88% completed the study. Following I-CoPE patients and carers reported fewer information needs (P < .001), while carers reported fewer unmet supportive care needs (P < .01) and increased preparedness to care (P = .04). Quality of life did not significantly change.

Conclusion

A model of supportive care delivered based upon illness transitions is feasible, acceptable, and suggests preliminary efficacy in some areas. Formal randomized studies are now required.

Despite substantial treatment advances, patients with high-grade glioma continue to face poor prognostic outcomes, with a median survival of just 14.6 months for patients with grade 4 tumors treated with multimodality treatment protocols.¹ The time of diagnosis and illness is punctuated by substantial cognitive, physical, social, and psychological morbidity with often devastating changes occurring even early in the illness course.²

The need for a cancer care coordinator in this illness is particularly poignant.^3–6 Patients navigate between different treatment approaches – surgery, radiotherapy, and medical oncology – throughout the illness. They have intense and complex needs,⁷ and up to 63% of patients⁸ and 72% of their carers⁹ experience significant distress.¹⁰ Patients with high-grade glioma and their carers describe their requirements for individualized information, continuity of care, emotional support, preparatory caring advice, and a need to sustain hope throughout the trajectory.^3,4,10,11

Research to date has largely focused on describing the patient and carer experience,^12,13 although more recently there is increased attention to establishing best methods of providing care.^14–18 Informed by our earlier work,^2,3,5,19,20 a model of supportive and palliative care whereby activities and interventions are delivered based upon key transition points in the illness course has been proposed.²¹ Within this model, key components of care are highlighted including coordination of care across modality of cancer treatment and across sites of care, regular assessment, staged information according to transition points in the illness course, proactive referral systems, and specific enquiry of, and response to, patients’ and carers’ concerns (Fig. 1).²¹

Fig. 1.

Framework of I-CoPE activities.

In short, the proposed model of supportive and palliative care anticipates problems; identifies and responds to problems early rather than waiting until fully established to react; provides information according to the stage of illness reached; stipulates routine referral to palliative care services at first recurrence of cancer (at minimum); includes the family carer; and is based upon illness or treatment milestones rather than time.²¹ Overarching the care provision is the role of cancer care coordinator who forms a relationship at diagnosis, checks in at regular times, conducts screening for concerns and responds accordingly, and provides staged information according to illness stage.

We sought to empirically test the initial stages of this model of supportive and palliative care, with a particular focus upon the provision of supportive care for patients with newly diagnosed high-grade glioma. The model centers upon the cancer care coordinators’ tasks of relationship forming and communication, staged information, screening, and responding to arising need. This component was termed I-CoPE (Information, Coordination, Preparation and Emotional support). Pilot testing of I-CoPE formed the next steps in testing of a complex intervention, consistent with Medical Research Council prescribed guidelines.²²

The aim of this study therefore was to examine the feasibility, acceptability, and preliminary effectiveness of I-CoPE for patients with high-grade glioma and their family carers.

Method

Design and Study Setting

This open-label, single-arm, pilot study tested a structured approach to the provision of supportive and palliative care for people with high-grade glioma and their family carers. This was embedded within an existing neuro-oncology service at a single tertiary center in Melbourne, Australia. Participants who provided written informed consent received the new model of supportive and palliative care (I-CoPE). The study was approved by the institutional human research ethics committee (protocol number 140/13).

Participants

Participants were adults newly diagnosed with high-grade glioma (grades 3 or 4) and their nominated family carers. In addition, eligible participants were able to provide informed consent, complete written English language instruments, and were planned for radiotherapy treatment. Consecutive eligible patients were approached (along with their carers) during their first inpatient admission in the week following biopsy and/or resection.

I-CoPE Intervention

The I-CoPE intervention involves the provision of Information, Coordination, Preparation and Emotional support (I-CoPE) over 3 key identified care transitions, for people newly diagnosed high-grade glioma and their carers (Fig. 1).

Staged information provision

Novel I-CoPE information resources were developed based on patient and carer reported needs,^3,4,23 and, consistent with the defined I-CoPE transition points, these written information resources were provided in a staged approach at the time of the I-CoPE interactions. The resource was individualized to each patient, with specific diagnostic information completed by the care coordinator. Information booklets were supplemented with additional (more specific) resources as required in response to concerns raised through the screening process. An example of this would be information pertaining to talking to young children about terminal illness, which was not relevant for all patients, but provided to those when this need was raised during screening.

At first contact, patients were provided with a resource folder that included both (1) generic information about high-grade gliomas, treatment options available, places to access further resources, and information including recommended websites and (2) individualised information including the patient’s diagnosis and site of tumor, some potential effects of a tumor in that specific site, names of treating clinicians, dates of appointments, and contact details of clinicians including the cancer care coordinator.

Regular screening for needs

The Distress Thermometer²⁴ was used as a screening tool, administered at each transition point, and used as a prompt to explore patients’ and family carers’ needs and concerns. This tool enables screening for practical, physical, family, emotional, and spiritual/existential concerns. This tool has been shown to be successfully administered to cancer patients and their carers using community-based telephone outcalls^25,26 and is well validated for use with brain cancer patients, with clearly defined cut-off scores to identify clinically relevant distress.^27–32

Provision of emotional support

Any concerns identified through the screening process undertaken at each transition were addressed with the patient and carer. This included provision of supportive counseling by the cancer care coordinators in response to attendant distress but recruiting additional psychological support services where appropriate.

Coordination activities

Coordination of care relevant to the patient’s supportive care, treatment planning, and follow-up was overseen by the cancer care coordinators. This included facilitating communication between medical teams and highlighting patient and family carer concerns to health professionals as appropriate.

Active engagement of family carers

With patient permission, family carers were included in consultations and discussions where information was given. Family carers and patients were specifically screened for concerns and subsequent responses to concerns were instituted.

The transition points at which I-CoPE was delivered corresponded to specific points early in the patients’ illness trajectory^2,4,19,20 and included: Transition 1: following patient’s pathological diagnosis after biopsy and/or resection in the acute hospital setting (I-CoPE A); Transition 2: following discharge (7–10 days postdischarge) from acute hospital setting (I-CoPE B); Transition 3: following the completion of standard radiotherapy protocol when patients were no longer attending for daily treatment (I-CoPE C).

I-CoPE was delivered by a cancer care coordinator who established a relationship with the patient and family carer, undertook communication tasks, and ensured clarity in coordinating treatment and follow-up activities. The cancer care coordinator roles were fulfilled by senior nurses with extensive oncology nursing experience and additional training in communication skills to support this role.

The specific tasks of the cancer care coordinator included: Provision of information staged according to the illness stage; regular screening for needs and responses instituted, including emotional support; coordination of care as patients moved between sites and disciplines; and active engagement of family carers (Fig. 1, Table 1). Importantly, I-CoPE provided a framework to enable a standardized approach to the (minimum) timing of interactions, and a method to identify needs while simultaneously enabling an individualized patient interaction. I-CoPE A was delivered face to face in the inpatient setting, and I-CoPE B and C were delivered by telephone.

Table 1.

Content of I-CoPE According to Transition Points

	Transition 1	Transition 2	Transition 3
Point in illness course	Time immediately following patient diagnosis of high-grade glioma	Following hospital discharge prior to commencing chemo/radiotherapy	Following completion of radiotherapy
Intervention	I-CoPE A: Face-to-face delivery	I-CoPE B: Telephone delivery	I-CoPE C: Face-to-face or telephone delivery
Communication content	Review diagnosis, treatment, understanding of illness Screen using Distress Thermometer and respond to needs – both patient and caregiver Information package tailored to Transition 1	Screen using Distress Thermometer and respond to needs – both patient and caregiver	Screen using Distress Thermometer and respond to needs – both patient and caregiver Information package tailored to Transition 3 Community links and follow-up

Outcomes

The primary outcome of interest was feasibility and acceptability of I-CoPE. Particular measures of feasibility included accrual to, and retention in, the study, and time taken to deliver the intervention, while measures of acceptability additionally included satisfaction with care and reflections upon the model by patients and family carers, as well as health professionals. Acceptability data were collected at study conclusion or at time of withdrawal from study for those participants who did not complete all interventions. For those who withdrew, reasons behind withdrawal were sought. Care coordinators kept diaries of activity, time spent on patient interactions and contemporaneous reflections during the study. Brief structured interviews were conducted with the care coordinators at the project conclusion to provide further reflections upon the model of care (Table 2).

Table 2.

Outcome Measures and Instruments

	Variable	Instrument
Feasibility and Acceptability	Accrual to the study	% eligible patients enrolled
	Retention in study	% enrolled patients completing study
	Time taken to deliver intervention	Minutes per contact Total time per patient and carer dyad
	Satisfaction with care	Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction - Patient Satisfaction scale (FACIT-TS-PS).41	Assesses 5 domains: physician communication; staff communication; nurse communication; technical competence; confidence/trust. Established internal consistency and construct validity.
	Health professional journals	Activities associated with study Notes on patient–caregiver interactions Reflections recorded contemporaneously
	Interviews with health professionals	Qualitative reflections upon the intervention
Patient- reported outcomes	Supportive care needs met	Supportive Care Needs Survey-Short Form (SCNS-SF34)42	Evaluates 5 domains: psychological, health system/information, physical/daily living, patient care/support, and sexuality needs. Construct and criterion validity, and internal consistency has been determined.42
	Information needs	Patient Information Needs Questionnaire (PINQ)43	Evaluates information needs in 2 domains: Information about disease and treatment; Information about accessing help, practical needs. Established internal consistency, construct and convergent validity44
	Quality of Life	Functional Assessment Cancer Therapy – Brain cancer module (FACT-BR)45	Evaluates patient functioning across 5 domains: physical; social and family; emotional well being; functional well being; and brain-cancer specific symptoms. Sensitive to fluctuations in patient level of functioning (treatment and performance status)
Carer- reported outcomes	Supportive care needs	Carer Support Care Needs Assessment Tool (CSNAT)46	Captures practical, emotional, spiritual and communication needs. Established face, content, and criterion validity and sensitivity to change46
	Information needs	Patient Information Needs Questionnaire (PINQ)43	As above for PINQ.
	Quality of life	Caregiver Quality of Life Index for Cancer (CQOLC)47	Measures quality of life across 4 domains: carer burden, disruptiveness, positive adaptation, and financial concerns. Acceptable convergent validity, test-retest reliability and internal consistency47,50
	Preparedness to care	Preparedness for Caregiving Scale (PCS)48	8-item scale Good construct validity and internal consistency35,49,51

Secondary outcomes of short-term effectiveness of the intervention were sought including patient and carer reports of unmet information and support needs, quality of life, and preparedness to care. The instruments used to measure effectiveness are detailed in Table 2. Patient and family carer outcome data were collected longitudinally prior to, during, and after the implementation of the I-CoPE model over a 3-month period as follows: Time 1 (T1, baseline/preintervention), Time 2 (T2, 2 weeks post-T1), and Time 3 (T3, 12 weeks post-T1) (Table 1).

Statistical Analyses

Primary outcomes of feasibility were assessed using percentages and appropriate summary statistics. Changes in mean scores on secondary patient- and carer- reported outcomes across time were assessed using within-subjects, repeated measures analysis of variance (ANOVA). Normality checks were carried out on the residuals to check they approximated a normal distribution. Mauchly’s test of sphericity was conducted and if sphericity could not be assumed, the Greenhouse-Geisser correction was applied.

Given the exploratory nature of planned analyses as part of a pilot trial, a 2-sided P value of .05 was considered significant. As such, given the expected small sample size in line with this pilot study design, emphasis was placed on the magnitude and direction of change. Partial eta squared (ƞp²) was calculated for each outcome variable to provide a standardized measure of effect size, with values of ≤ .01 considered small, ≤ .06 medium, and ≤ .14 large effects.^33,34

Where secondary outcomes showed significant change across time, post hoc pairwise comparisons were then conducted to assess the nature of these changes. Given there were multiple comparisons conducted, the Bonferroni correction was applied and P values adjusted accordingly. Repeated measures ANOVA analyses conducted on the secondary outcomes reported by patients and caregivers at each time point only included complete cases, with no observations carried forward. Differences in socio-demographic characteristics of non-completers (compared to completers) were assessed [but no significant differences were found (P > .05)]. Missing data were systematically examined for each outcome variable. Less than 5% of items were missing across any one subscale, and therefore determined to be missing at random, with no replacement methods used.

Results

Participants

Thirty-two patients participated in the I-CoPE study (17 males, 53%). Mean age was 61 years (SD = 13.0), and the majority of patients were partnered (n = 19, 59%). At the time of enrollment, most patients had a grade 4 diagnosis (n = 25, 78%) and had undergone surgical resection (n = 28, 88%). One-third of patients suffered from an additional chronic medical condition (Table 3).

Table 3.

Demographics and Clinical Details of Participants

	Patients N = 32	Carers N = 31
Age in years: mean, SD, (range)	60.8, 12.7 (28–82)	55.7, 12.9 (33–85)
Male sex	17	13
Marital status
Married/de facto	19	22
Never married	4	3
Divorced / separated /widowed	9	6
Education level
Secondary education	9	13
Tertiary or equivalent	11	17
Not recorded	2	1
Employment at time of diagnosis
Full time	9	13
Part time	5	5
Not paid employment	18	13
Tumor type
Grade 4	25
Grade 3	7
Histology
Glioblastoma	24
Mixed anaplastic oligodendroglioma	1
Astrocytoma grade 4	1
Anaplastic astrocytoma grade 3	2
Anaplastic oligodendroglioma	2
Anaplastic oligoastrocytoma	2
Tumor site
Parietal	8
Temporal	9
Frontal	10
Multifocal	2
Cerebellum/brainstem	3
Surgery
Resection	28
Biopsy only	4
Concurrent medical condition	12	7
Relationship to patient
Spouse/partner		25
Child		5
Parent		1
Friend		1

Thirty-one carers participated (13 males, 42%). The mean age was 56 years (SD = 12.9) (Table 3). Most carers were a spouse (n = 25, 81%) and living with the patient (n = 26, 84%).

Primary Feasibility and Acceptability Outcomes

Accrual and retention rates

Of 48 potential patients admitted with a new diagnosis of high-grade glioma during the study period, 11 were ineligible (cognition, non-English speaking, poor health including infective and/or cardiac problems precluding ability to complete questionnaires), leaving 37 eligible patients. Of these, 5 declined participation, while 32 agreed to participate and completed T1 data (86% enrollment rate). A total of 29 and 28 patients completed T2 and T3 data, respectively (88% completion rate). Of the 31 carers enrolled, 30 and 29 completed T2 and T3 data, respectively (94% completion rate). Reasons for study withdrawal or missing data were deteriorating health or death (n = 4) (Fig. 2).

Fig. 2.

Consort diagram of patient/carer recruitment and study completion.

In total, the time spent over all planned interactions between the care coordinator and participant was 80 minutes per patient (range, 40–160 minutes), and 69 minutes per carer (range, 45–130 minutes). The first interaction was in general of longest duration (delivery of I-CoPE A, B, and C took mean 45, 13, and 26 minutes for patients, and 27, 21, and 19 minutes for carers, respectively). In addition to the planned interactions, a number of spontaneous contacts were made: carers called the care coordinator a median of 2 calls (range, 0–11), while for patients the median number of calls was 0 (range, 0–2 calls). Based on the time spent, a rudimentary cost analysis of the mean cost of I-CoPE delivery per patient–carer dyad was AUD $137.

Satisfaction with care

At the conclusion of I-CoPE, patients rated their experiences and satisfaction with their neuro-oncology care over the 3 months from diagnosis. This included the whole experience of care, not just specific to I-CoPE. Overall, patient and carers’ experiences were favorable, with a majority of patients (n = 26, 81%) rating the overall care received as at least “very good” (median score 4 out of 5, representing “very good overall care”). Similarly, a majority of carers (n = 27, 87%) rated the overall care received as “excellent” (median score 5 out of 5 representing “excellent overall care”).

Carers reported a high satisfaction with the communication with their care team (communication subscale score of mean = 27; SD = 7; median = 28) and very high satisfaction with their level of confidence and trust in their care team (score mean =10; SD = 1.6; median = 10). Though there was some variation in patient experience, overall patients also reported high satisfaction with communication with their care team (score mean = 28; SD = 10; median = 34) and their level of confidence and trust in their care team (score mean = 10; SD = 2.5; median = 11).

Health professional reflections

Review of the I-CoPE diaries (documented by the care coordinators) revealed the feasibility of screening patients, including those patients with poor health and/or speech or language difficulties. Even for those patients with significant morbidity, the Distress Thermometer framework evoked conversation and identified concerns as evident in diary documentation.

Interviews of cancer care coordinators revealed the timing of interventions according to transition points was considered practical in terms of workload and times of change for patients, as well as enabling timely identification of patients’ and carers’ emergent needs. They reported that duration of screening was manageable relative to usual care delivered in the past, and was associated with fewer spontaneous calls from patient and carer.

The selected face-to-face initial I-CoPE A delivery format, followed by the telephone format for follow-up I-CoPE screens was considered very useful. Specifically, it allowed for establishment of rapport in person and for the patient and carer to be orientated to the Distress Thermometer screening process prior to follow-up telephone based care.

Moreover, the cancer care coordinators expressed strong satisfaction with the I-CoPE model of supportive care and coordination for patients with high-grade glioma and their carers. The satisfaction was primarily related to (1) improved communication experiences, allowing safety for challenging discussions to occur within the I-CoPE framework, and (2) the provision of greater role definition, structure, and consistency of care.

Secondary Patient and Carer Reported Outcomes

Patients reported no significant change in their supportive care needs over the period, but did have reduced information needs (P < .01), while carers had both a reduction in supportive care and information needs (Table 4). Quality of life did not change significantly for either group.

Table 4.

Secondary Outcomes Reported by Patients and Caregivers.

Secondary Outcome	Outcome Measure	F statistic, Repeated measures ANOVA	P value	T1		T2		T3		Effect size	Pairwise comparison with Bonferroni correction
				Mean	SD	Mean	SD	Mean	SD
Supportive care needs	Patient SCNS -SF34	F(2, 44) = 0.59	.557	77.43	30.97	72.57	32.01	78.91	29.05	ƞp2 .026	n.s.
	Caregiver CNSAT	F(1.36, 33.96) = 6.56 #	.009*	14.31	10.26	9.08	7.98	7.77	8.18	ƞp2 .208	T1-T3: .019 *
Information needs	Patient PINQ	F(2, 46) = 8.49	.001	29.87	17.74	20.88	19.30	20.50	18.13	ƞp2 .270	T1-T3: .007 *
	Caregiver PINQ	F(2, 50) = 12.36	< .001*	19.50	11.60	11.19	7.50	12.50	10.79	ƞp2 .331	T1-T3: .002 *
Quality of life	Patient FACT-Br	F(2, 42) = 6.72	.003*	127.12	27.10	138.07	32.91	124.27	29.38	ƞp2 .242	T1-T2: .042* T2-T3: < .001*
	Patient FACT-G	F(2, 42) = 11.51	< .001*	77.10	16.98	86.50	21.32	73.36	18.22	ƞp2 .354	T1-T2: .010* T2-T3: < .001*
	Caregiver CQOLC	F(2,44) = 2.65	.080	56.09	18.51	49.96	21.75	50.26	18.43	ƞp2 .107	n.s.
Preparedness to care	Caregiver PCS	F(1.49, 37.42) = 3.73 #	.042*	17.38	7.71	19.77	6.70	19.73	5.30	ƞp2 .130	T1-T3: .043 *

*significant difference across time; n.s. = non-significant.

# Greenhouse-Geisser correction applied.Abbreviations: SCNS-SF34, Supportive Care Needs Survey - Short Form; CNSAT, Carer Support Care Needs Assessment Tool; PINQ, Patient Information Needs Questionnaire; FACT-Br, Functional Assessment of Cancer Therapy - Brain cancer module; FACT-G, Functional Assessment of Cancer Therapy - General; CQOLC, Caregiver Quality of Life Index for Cancer; PCS, Preparedness for Caregiving Scale.

Discussion

The results of this pilot study highlight the feasibility, acceptability, and applicability of the I- CoPE model of care. Acceptability was demonstrated by the 86% enrollment rate of patients and their nominated carers. Applicability of the I-CoPE components (information and education, coordination, preparation and emotional support) was evident by the full cohort’s continued I-CoPE participation in the context of a busy treatment schedule and a new poor prognosis diagnosis. Finally the model was feasibly delivered: the collective patient and carer average duration of I-CoPE was 149 minutes, and care coordinators felt it represented an acceptable workload and did not result in large numbers of unplanned additional calls. Preliminary data suggested the I-CoPE model was associated with benefits over time, including fewer information and supportive care needs for carers, as well as greater preparedness to provide care. Importantly, these outcomes are consistent with those things highly valued by patients navigating serious illness.³⁵

It is of note that I-CoPE provides a structure of support for the patient and carer as they attempt to sustain hope while also preparing for longer term changes including new and permanent losses, relationship changes and impending mortality. This is achieved through the formation of a key supportive relationship with the cancer care coordinator which is maintained over time; the provision of staged information, in recognition that there is a readiness to hear things at different times in the illness course; and the regular screening for concerns using the Distress Thermometer and responding accordingly.

Furthermore, health professionals reported benefits associated with the model of supportive care including that it provided structure, consistency, and role definition to the care coordinator role. This enabled easier interactions with rich and full communication exchanges, focused goals of the interaction, and less wasted time as patients’ and carers’ concerns were identified and explored. The small number of additional unplanned contacts with the patients and carers suggested that the screening points and their frequency were mostly sufficient to respond to emergent needs. Meanwhile, the use of the Distress Thermometer at transition points was feasible and unlike earlier studies that have implemented screening for distress without demonstrated improvement in patient and carer quality of life,^36,37 the current pilot suggests the multi-faceted nature of I-CoPE delivered around care transitions in the illness course gave rise to promising benefits. Such preliminary findings must be tested formally in a randomized trial.

Importantly this study points to positive evidence of efficacy of cancer care coordination roles. Clinicians consistently express high levels of support for these roles, yet empirical evidence of efficacy continues to be patchy.³⁸ A recent systematic review identified methodological shortcomings, inadequate conceptualization of the care coordination intervention, and insufficient intervention description.³⁸ The authors conclude that overall insufficient evidence is available in existing literature to determine whether care coordination interventions have a positive impact on patient- or family- reported outcomes.³⁸

This study tests a structured approach to cancer care coordination with specified activities delivered at key times identified in the illness, along with supported approaches to conversations and structured means of establishing a relationship and lines of communication. Using this approach, the preliminary outcomes of efficacy demonstrated in this study suggest a way forward to more rigorously demonstrate the full impact of care coordination in cancer care. This study is the pilot phase of evaluating complex interventions according to the Medical Research Council framework, and so therefore not only are the activities of the care coordinator designed and delivered according to key identified needs, but the measures are specifically targeted to these activities and their anticipated impact. Therefore we believe that the results of this study and subsequent further testing will also have implications for the delivery and measurement of care coordination in other cancers.

Other groups have adopted different approaches to address the supportive care needs of this patient and carer cohort. Hansen and colleagues have developed an intensive rehabilitation program delivered by an interdisciplinary team to outpatients with primary glioma. This randomized study will test the role of exercise and its benefits in this patient group, with attention to quality of life and symptom outcomes in addition to physical functioning.¹⁴ Meanwhile Halkett et al have focused on approaches to improve the well being and outcomes for carers of patients with high-grade glioma.¹⁵ They have developed a supportive educational intervention consisting of a personalized resource package tailored according to an assessment of needs, and ongoing support in person and by telephone for 12 months. This intervention, Care-IS, has undergone pilot testing revealing acceptability, and a randomized controlled study is now underway.¹⁸ The increasing attention to structured approaches to improve patient and carer outcomes reflects the recognition that supportive care needs must be addressed throughout the illness course.³⁹

A number of limitations mean the findings of this current study must be interpreted with caution. In particular, the study was primarily designed to test feasibility and acceptability. The findings suggesting effectiveness must be formally subject to a controlled, randomized study. The study was conducted in a single center and its successful implementation may be dependent upon that center’s personnel. The impact of progressive neurological deterioration on the outcomes of this study, including quality of life data has not been explored, and would require further qualitative and neurocognitive examination to be fully understood. Finally, the inclusion of only those English-speaking participants means, in the state of Victoria, Australia, up to 23% of patients would ineligible.⁴⁰ The acceptability of the I-CoPE model to this large minority cannot be assumed, and a tailored, translated form of I-CoPe must be formally tested. These limitations should be specifically addressed in future phase 3 studies of the model.

Nevertheless, the positive preliminary results of this pilot implementation of I-CoPE into a tertiary Australian neuro-oncology service – both in terms of feasibility and acceptability of the I-CoPE model, and efficacy in some patient and carer reported outcomes – show promise for further testing via a randomized controlled trial. We attribute the preliminary success of this study to the underlying principle of a tailored model based upon predefined transitions in the illness course. Such an approach has potential application for the introduction of other forms of support in a timely manner according to subsequent points reached over the illness course, including for those who develop tumour progression and must navigate end of life care.

Funding

This study was supported by the Australian Primary Health Care Research Institute, Department of Health and Ageing, Commonwealth Government of Australia.

Conflict of interest statement. None of the authors (neither Jennifer Philip, Anna Collins, Jane Staker nor Michael Murphy) have any conflicts of interest to declare in relation to this manuscript.