Symptom screening with Targeted Early Palliative care (STEP) versus usual care for patients with advanced cancer: A mixed methods study

doi:10.21203/rs.3.rs-2501255/v1

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Research Article

Symptom screening with Targeted Early Palliative care (STEP) versus usual care for patients with advanced cancer: A mixed methods study

https://doi.org/10.21203/rs.3.rs-2501255/v1

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Journal Publication

published 21 Jun, 2023

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Purpose: Although early palliative care is recommended, resource limitations prevent its routine implementation. We report on the preliminary findings of a mixed methods study involving a randomized controlled trial (RCT) of Symptom screening with Targeted Early Palliative care (STEP) and qualitative interviews.

Methods: Adults with advanced solid tumors and an oncologist-estimated prognosis of 6-36 months were randomized to STEP or symptom screening alone. STEP involved symptom screening at each outpatient oncology visit; moderate to severe scores triggered an email to a palliative care nurse, who offered referral to in-person outpatient palliative care. Patient-reported outcomes of quality of life (FACT-G7), depression (PHQ-9), symptom control (ESAS-r-CS), and satisfaction with care (FAMCARE P-16) were measured at baseline and 2, 4, and 6 months. Semi-structured interviews were conducted with a subset of participants.

Results: From Aug/2019 to Mar/2020 (trial halted due to COVID-19 pandemic), 69 participants were randomized to STEP (n=33) or usual care (n=36). At 6 months, 45% of STEP arm patients and 17% of screening alone participants had received palliative care (p=0.009). Nonsignificant trends for all outcomes favored STEP: difference in change scores for FACT-G7=1.67 (95% CI: -1.43,4.77); ESAS-r-CS=-5.51(-14.29,3.27); FAMCARE P-16=4.10(-0.31,8.51); PHQ-9=-2.41 (-5.02,0.20). Sixteen patients completed qualitative interviews, describing symptom screening as helpful to initiate communication; triggered referral as initially jarring but ultimately beneficial; and referral to palliative care as timely.

Conclusion: STEP improves access to palliative care. Despite lack of power, preliminary results are encouraging and qualitative results demonstrate acceptability. Findings will inform an RCT of combined in-person and virtual STEP.

ClinicalTrials.gov Identifier: NCT03987906

Randomized controlled trial

palliative care

symptom screening

cancer

quality of life

qualitative research

Early palliative care (EPC) for patients with advanced cancer is recommended in practice guidelines, based on several randomized controlled trials.[1–8] However, routine early involvement of specialized palliative care teams is not possible due to international shortages of specialized palliative care professionals.[9, 10] Although targeted involvement of specialized palliative care has been proposed, this model has not yet been tested in randomized controlled trials.[11] Patients with the most severe symptoms have the greatest palliative care needs,[12] and tend to benefit most from EPC intervention.[13] Thus, routine symptom screening and triggered palliative care referral could be a way to direct palliative care to those most likely to benefit.

We previously reported on a single-arm Phase II trial of Symptom screening with Targeted Early Palliative care (STEP) for patients with advanced cancer. Results demonstrated that STEP was feasible, targeted EPC to the patients who needed it most, and resulted in improved symptoms and mood in those receiving the EPC intervention.[14] Here we report on the preliminary results of a mixed methods study that included a randomized controlled trial of in-person STEP, with a qualitative component to understand the experiences of patients in both trial arms. The trial was halted early due to the COVID-19 pandemic in March 2020, as a result of the rapid change to virtual symptom screening and virtual palliative care delivery. Here we report on the study results, which provide valuable information for planning further trials in this area.

Mixed methods methodology

An explanatory sequential design was used, whereby the quantitative component of the intervention was completed first, followed by the qualitative component.[15, 16] This design is most commonly utilized to evaluate complex interventions, with the individual experiences of patients (through the qualitative component) being used to better understand and interpret the quantitative results.[17] A combined sampling approach was used from the single target population that participated in the study,[18] with recruitment of a subset of available participants from the quantitative component for the qualitative study.

Setting and participants

This study was conducted at the Princess Margaret Cancer Centre (PM), part of the University Health Network, in Toronto, Ontario, Canada. Patient participants were recruited by the study team from outpatient medical oncology clinics of the Lung, Gastrointestinal, Genitourinary, Breast and Gynecology tumor sites. Eligibility criteria were age ≥ 18 years, advanced cancer (stage IV; endocrine-resistant or hormone-refractory for those with breast or prostate cancer, respectively, and stage III disease for lung and pancreatic cancer), ECOG (Eastern Cooperative Oncology Group)[19] performance status score of 0 to 2, willingness to complete electronic ESAS-r symptom screening, completion of baseline measures within three days of symptom screening, and estimated survival (by treating oncologist) of 6–36 months. Exclusion criteria were insufficient English literacy to complete questionnaires, poor cognitive status (Short Orientation-Memory-Concentration [SOMC][20]score < 20 or > 10 errors), or previous referral to a palliative care team. All participants provided written informed consent and completed baseline measures within 3 days of recruitment. This study was approved by the University Health Network Research Ethics Board (REB# 19-5007).

Randomization and study arms

Stratified permuted block randomization (stratified by tumor site and symptom severity strata) allocated participants to STEP or screening alone (usual care at PM). The randomization list was computer-generated and managed by an independent biostatistician in the PM Department of Biostatistics.

Usual oncology care involved symptom screening with the Edmonton Symptom Assessment System-revised version (ESAS-r)[21] routinely at each outpatient visit on a tablet or computer in the waiting room of the oncology clinic before appointments. The ESAS-r includes symptoms of pain, shortness of breath, nausea, depression, anxiety, appetite, fatigue, drowsiness, and well-being; symptoms are rated based a time window of “now” from 0–10, where 0 is best and 10 is worst. Paper versions of the ESAS-r were available for patients who preferred this option; these results were subsequently entered manually into the database by clinic staff. Routine ESAS-r screening of all patients attending oncology appointments has been mandatory at all cancer centers in Ontario since 2008.[22, 23] Oncology nurses reviewed ESAS-r scores, discussed these with patients and communicated results to oncologists for further intervention or referral. Patients could be referred to the PM Palliative Care Clinic (PCC) at any time if requested; care in the PCC was the same as for the STEP arm (detailed below), but with follow-up as needed rather than monthly. ESAS-r results were stored in a central database and entered into the hospital’s electronic health record.

The STEP group received the screening described above, with triaged referral to the PCC following an algorithm based on symptom severity (Fig. 1).[14] A symptom severity rating of 4–10/10 (pain, shortness of breath, nausea, depression, or anxiety) or 7–10/10 (appetite, fatigue, drowsiness, or well-being) on the ESAS-r, triggered an automatic email alert for these “screen-positive” patients to the palliative care triage nurse and study team. Within 3 business days, the triage nurse called the participant to further assess symptom severity, explain the EPC intervention, and offer a referral to the outpatient PCC. Patients accepting referral received an EPC intervention, described below; those who declined continued routine screening at every clinic visit. The triage nurse informed the oncology team of the telephone assessment outcome.

Screen-positive participants accepting the referral received an EPC intervention that demonstrated efficacy in a Phase II study[24] and in a Phase III trial.[3] This included: (1) In-person consultation in the PCC within 1–2 weeks (Fig. 1); (2) A comprehensive multidisciplinary assessment of symptoms, psychological distress, social support and home services, with treatment following provincial Cancer Care Ontario Symptom Management Guidelines;[25] (3) Monthly follow-up in the PCC for 6 months (more often if requested); (4) Access to a 24-hour on call service for telephone management of urgent issues; (5) Assessment of need for home nursing care and arrangement of services as necessary; (6) Transfer of care to a home palliative care team when ECOG performance status ≥ 3 or when the patient desired home-based care; (7) Availability of dedicated inpatient beds for urgent symptom issues and end-of-life care. If the patient was admitted to another service at PM, the palliative care team followed the patient and provided advice.

Patients in both arms could also be referred to EPC by their oncologist at any time during the study. If this occurred, the EPC intervention was delivered as described above, except for the timing of follow-up visits, which was as-needed rather than monthly for usual care participants. After study completion, all patients who had been referred to EPC were offered continued follow-up on an as-needed basis.

Quantitative and qualitative data collection

All participants completed patient-reported outcomes (PROs) of quality of life, depression, symptom control, and satisfaction with care at baseline and at 2, 4, and 6 months post-baseline (either mailed or completed in person). Those who did not return an assessment within 2 weeks received up to 3 reminder calls from research staff; those who could not be reached were considered lost to follow-up for that assessment. The FACT-G7 scale is an abbreviated version of the Functional Assessment of Cancer Therapy – General (FACT-G) scale, which is designed to capture the issues most relevant to the quality of life of patients with advanced cancer.[26] The ESAS-r-CS is a modified version of the ESAS-r.[27] It assesses symptom burden and includes eleven patient-reported scales with anchors of 0 (best) and 10 (worst) for pain, fatigue, drowsiness, nausea, anxiety, depression, appetite, dyspnea, well-being, constipation and sleep over the last 24 hours; these are summed for the ESAS-r-CS Total Distress Score (TDS). The Patient Health Questionnaire-9 (PHQ-9) is a DSM-5-concordant measure for screening, diagnosing and monitoring the severity of depression.[28–30] The FAMCARE-P16 scale measures patient satisfaction with aspects of care in patients with advanced cancer.[31] All measures have been validated in patients with advanced cancer.

The primary endpoint was the FACT-G7 total score at 6 months; this time point was chosen based on findings from our previous Phase II trial to minimize loss to follow-up while maximizing impact of the intervention.[14] Secondary endpoints were FACT-G7 total score at all other time points and all other PROs at all time points.

In-depth, semi-structured qualitative interviews were conducted with a sample of participants from the STEP and usual care groups. Interviews were conducted exclusively by telephone due to the COVID-19 pandemic and ranged from 15–90 minutes. STEP participants were asked about their experiences and perspectives regarding STEP, including symptom screening, the triggered phone call, and the EPC intervention. Usual care participants were asked about their experience of symptom screening alone. Interviews were audio-recorded and transcribed verbatim by an independent transcription service, with subsequent review by the research team to ensure accuracy. Interview transcripts were de-identified to protect participants’ confidentiality.

Sample size and quantitative and qualitative analyses

For quantitative analyses, the target sample size was 410 patients (205 per group), based on a minimally important difference (MID) for the FACT-G7 of 1.68 and a standard deviation of 4.5. The MID for the FACT-G has not been determined, but for quality of life measures, clinically significant differences are typically in the range of 3–10% of the total scale.[32, 33] We used 6% of the total FACT-G7 scale as the MID, which is 1.68. For qualitative analyses, we had a flexible sample size target, based on saturation of themes.

All quantitative analyses were by intention to treat, with patients analyzed in the arms to which they had been randomized. Chi-square test was performed to assess the difference in the proportions of patients who received EPC in the STEP and usual care arms. For analysis of PROs, we adjusted for baseline PRO scores, as well as symptom strata, tumor site, and other variables showing important levels of imbalance between trial groups. The changes in PRO scores for all patients at each follow-up was calculated for the STEP and usual care groups and compared using ANCOVA at 6 months. In keeping with scoring guidelines, in cases where there were missing items for the PRO measures, scores were prorated as long as > 50% of the items were answered.

Qualitative data collection and analysis took place concurrently. We employed a qualitative descriptive methodology,[34] using thematic analysis to generate themes.[35] A coding guide was generated inductively and was further refined with subsequent interviews. Coding was done by four independent researchers; codes and resulting themes were then discussed and refined in weekly research team meetings.

Quantitative Randomized Controlled Trial

From August 2019 to March 2020, 69 patients provided written consent and completed baseline measures: 33 were randomized to STEP and 36 to usual care (Fig. 2). Recruitment was then halted due to restrictions imposed by the COVID-19 pandemic. There were no major baseline demographic or clinical differences between trial groups at baseline, except that a smaller number of men were randomized to the intervention arm compared to usual care (Table 1). PROs were similar between arms at baseline. Within the STEP arm, 20 patients were screen-positive, of whom 13 attended the PCC at least once; 13 were screen-negative, of whom 2 were nevertheless referred to the PCC by their oncologist during the study period. In the usual care arm, 6 patients were referred to palliative care between recruitment and the 6-month endpoint. Patients in the STEP arm were more likely to receive EPC by trial-end than those in the usual care arm (15/33 [45%] versus 6/36 [17%], p = 0.009).

Table 1. Patient demographic and clinical characteristics by study arm

	STEP N=33	Usual Care N=36
Age in years, median (range)	64.0 (25.0-79.0)	64.0 (39.0-87.0)
Sex
Female	25 (75.8%)	18 (50.0%)
Male	8 (24.2%)	18 (50.0%)
Tumor site
Gastrointestinal	9 (27.3%)	10 (27.8%)
Lung	9 (27.3%)	9 (25.0%)
Gynaecological	7 (21.2%)	6 (16.7%)
Genitourinary	4 (12.1%)	6 (16.7%)
Breast	4 (12.1%)	5 (13.9%)
Ethnic background
European	15 (48.4%)	26 (74.3%)
Southeast Asian	5 (16.1%)	3 (8.6%)
East Asian	3 (9.7%)	4 (11.4%)
African/African-American	4 (12.9%)	1 (2.9%)
South Asian	3 (9.7%)	0 (0.0%)
Central/South American	1 (3.2%)	1 (2.9%)
Marital status
Married/Common law	21 (63.6%)	27 (75.0%)
Single	8 (24.2%)	6 (16.7%)
Widowed	2 (6.9%)	2 (5.6%)
Separated/Divorced	2 (6.1%)	1 (2.8%)
Highest level of education
College/University	23 (69.7%)	30 (83.3%)
High school completed	8 (24.2%)	5 (13.9%)
High school incomplete	2 (6.1%)	1 (2.8%)
Employment status
Retired	18 (54.5%)	17 (47.2%)
Employed/Self-employed	11 (33.3%)	11 (30.6%)
On disability	3 (9.1%)	6 (16.7%)
Unemployed	1 (3.0%)	2 (5.6%)
Average household income
<$15 000	1 (3.6%)	1 (3.3%)
$15 000 - $29 999	5 (17.9%)	1 (3.3%)
$30 000 - $59 999	9 (32.1%)	9 (30.0%)
$60 000 - $99 999	2 (7.1%)	9 (30.0%)
≥100 000	11 (39.3%)	10 (33.3%)
ECOG
0	7 (21.2%)	5 (13.9%)
1	26 (78.8%)	31 (86.1%)
CCI score
0	18 (54.5%)	23 (63.9%)
1	8 (24.2%)	9 (25.0%)
2	4 (12.1%)	1 (2.8%)
3	2 (6.1%)	1 (2.8%)
4	1 (3.0%)	2 (5.6%)
Baseline PRO score, mean (SD)
FACT-G7	18.5 (5.1)	19.7 (4.3)
ESAS-r-CS TDS	20.7 (16.9)	20.0 (13.1)
FAMCARE-P16	67.3 (12.5)	70.3 (12.2)
PHQ-9	4.4 (4.3)	4.9 (3.6)

Data are n (%) unless marked otherwise. Missing: ethnic background, n=3; household income, n=11. ECOG, Eastern Cooperative Oncology Group performance status score; CCI, Charlson Comorbidity Index;[42] PRO, patient-reported outcome; SD, standard deviation; FACT-G7 score, sum of 7 items of Functional Assessment of Cancer Therapy-General (higher scores are better); ESAS-r-CS TDS score, sum of all 11 Edmonton Symptom Assessment System-revised with the additional symptoms of constipation and sleep (lower scores are better); FAMCARE-P16 score, sum of all 16 items in FAMCARE-Patient scale (higher scores are better); PHQ-9 score, sum of all Patient Health Questionnaire-9 items (lower scores are better); CCI score, weighted score on the basis of the presence of various medical disorders, each of which is assigned a score of 1, 2, 3, or 6 based on the CCI scoring index (scores are summed to provide a total score for each patient; lower scores are better).

There was less deterioration in quality of life at 6 months from baseline in the STEP arm versus usual care (FACT-G7 mean change score − 0.2 [95% CI: -2.9, 2.4] versus − 2.1 [-4.4, 0.3], respectively), but the difference was not statistically significant (Table 2, Fig. 3). At study end, all secondary outcomes also tended to be better in the STEP arm compared to usual care, without reaching statistical significance. The difference in change scores for PROs was as follows: FACT-G7 = 1.67 (95% CI: -1.43, 4.77); ESAS-r-CS = -5.51 (-14.29, 3.27); FAMCARE P-16 = 4.10 (-0.31, 8.51); PHQ-9 = -2.41 (-5.02, 0.20).

Table 2

Change from baseline in patient-reported outcomes in the STEP and usual care arms at 6 months
PRO Measure	STEP (N = 33)		Usual Care (N = 36)		Difference in change scores between STEP and Usual Care
	n	Observed change from baseline Mean [95% CI]	n	Observed change from baseline Mean [95% CI]	Estimate [95% CI]¹	P¹	P²	P³
FACT G7
2 months	20	-1.0 [-3.1, 1.0]	33	-3.1 [-4.7, -1.5]
4 months	25	-1.7 [-4.1, 0.6]	30	-2.4 [-4.2, -0.7]
6 months	21	-0.2 [-2.9, 2.4]	24	-2.1 [-4.4, 0.3]	1.67 [-1.43, 4.77]	0.30	0.43	0.55
ESAS-r-CS TDS
2 months	20	3.4 [-4.4, 11.1]	33	3.4 [-0.3, 7.1]
4 months	25	5.7 [-2.7, 14.0]	30	7.5 [2.2, 12.8]
6 months	21	3.7 [-4.0, 11.3]	24	8.4 [1.5, 15.3]	-5.51 [-14.29, 3.27]	0.22	0.30	0.39
FAMCARE-P16
2 months	20	-0.3 [-3.0, 2.5]	33	-0.8 [-7.0, 5.3]
4 months	25	-1.4 [-4.8, 2.0]	30	-0.6 [-6.0, 4.7]
6 months	21	-0.5 [-4.4, 3.4]	25	-4.2 [-7.2, -1.2]	4.10 [-0.31, 8.51]	0.08	0.14	0.22
PHQ-9
2 months	20	0.2 [-1.9, 2.3]	33	0.9 [0, 1.8]
4 months	25	1.4 [-0.7, 3.6]	30	1.9 [0.2, 3.6]
6 months	21	0.5 [-2.0, 3.0]	25	1.7 [-0.3, 3.7]	-2.41 [-5.02, 0.20]	0.08	0.14	0.19
¹Adjusting for baseline PRO score. ²Adjusting for baseline PRO score, symptom strata and tumor site. ³Adjusting for baseline PRO score, symptom strata, tumor site and sex. Abbreviations: PRO, patient-reported outcome; CI, confidence interval; FACT-G7 score, sum of 7 items of Functional Assessment of Cancer Therapy-General (higher scores are better); ESAS-r-CS TDS score, sum of all 11 Edmonton Symptom Assessment System-revised with the additional symptoms of constipation and sleep (lower scores are better); FAMCARE-P16 score, sum of all 16 items in FAMCARE-Patient scale (higher scores are better); PHQ-9 score, sum of all Patient Health Questionnaire-9 items (lower scores are better).

Qualitative findings

Of the 20 patients who were approached for participation in the qualitative study, 19 expressed an interest in participation; 3 subsequently declined or withdrew, and 16 were interviewed (9 in the STEP arm who were screen-positive, 4 in the STEP arm who were screen-negative, and 3 in the usual care arm). The themes are described below.

Symptom screening: A good starting point but not the whole picture

Overall, patients noted that symptom screening was “a good starting point” (SP[screen-positive]-033[patient number]), and served as a “tool for communication” with the treating oncology team (SN[screen-negative]-021). Screen-positive patients remarked that completing the symptom screening “help[ed] the doctor [to] understand more about me” (SP-011), and to “sort of know what you’re feeling like” (SP-009). Patients emphasized the importance of discussing their scores with their healthcare team to “give me a chance to kind of reflect back on what I am putting down” (SP-032), particularly since “just putting a number is not always giving the whole picture” (SP-033).

Of note, some patients – particularly those who were in the usual care group or screen-negative STEP participants – expressed that they did not understand the utility of routinely completing symptom screening. They felt that their scores “went off into never-never land” (UC[usual care arm]-031) and “nobody tells me that those data [are] feeding back to… anything that would affect me” (SN-065). Others who were screen-negative pointed out the limitation of the time window of “now” on the ESAS-r: “there could be days before that where I was feeling sad or feeling, you know, worried, but answering them during that point in time”. (SN-044)

Triggered phone call: Initially shocked but ultimately comforted

Some patients could not sufficiently differentiate the triggered phone call from others calls they had received to be able to comment on the triggered phone call. However, those who remembered the call stated it “caught me by surprise” (SP-011) or “shock[ed] you into reality” (SP-032), particularly given their preconceptions that palliative care meant “we can’t do nothing more for you” (SP-032). However, education about palliative care by the nurse conducting the phone call was perceived to be helpful to alleviate patients’ concerns: “since the nurse had explained to me that [palliative care] is more than just (…) end of life, I decided that okay, maybe I’ll go” (SP-032).

Some patients felt that the initiation of palliative care at the time of the triggered call was timely:

“…it made me feel like, you know, good in the sense because I wasn’t in a good place at that time, even compared with today. And, not being able to function was very hard and I was just wondering if this is how things are and they’re going to get even worse than this, how will I manage and stuff. So, yeah, getting in touch with them and talking and finding out about different resources to handle the situation was very helpful, yeah.” (SP-033)

Other patients felt that although the call came a bit early, it “started a relationship… it made me feel sort of comforted knowing that it’s not going to happen for me to be referred at a later date when I’m sort of more in crisis; it’s while I’m still sort of doing well.” (SP-009)

Early palliative care: Extra support to live life to the fullest

Patients who received the triggered referral described the palliative care team as providing “extra support” (SP-009) or “added help, aside from the oncology team” (SP-071) and described the palliative care team as attentive to their needs: “with the palliative [care team], you can relate more, can explain more.” (SP-071) Many appreciated the additional support they were given to manage their symptoms, address their psychosocial needs, and provide information about their illness.

When I came to [palliative care physician] I feel like trapped and scared… I could not walk, could not eat, and feel hurt all the time… I’m really like fortunate that [palliative care physician] help me understand about my symptoms and about my cancer… I feel that I’m in good hands with the doctor. (SP-011)

[I]t’s a nice feeling for me that I have my palliative care team to help me to manage the signs and symptoms… it reminds me that despite of having cancer, I can still have a good opportunity to live my life to the fullest, not experience too much pain, and have additional information that I am gaining from all the doctors… all the nurses. (SP-062)

Overall, the palliative care team was seen as providing overall management to “help me to have back my quality of life” (SP-062); “they’re willing to point me in different directions… so that quality of life can be improved as much as possible” (SP-033).

Patients who were screen-negative but were nevertheless referred to EPC by their oncologist were similarly positive in their remarks but saw the palliative care team as a preventative resource: “it’s kind of like a one stop for everything that you may need in the future. And I think it’s a good referral for people. Like, you know, as long as they understand that, you know, it’s planning for the future; it’s not a ‘now’ thing.” (SN-044) The explanation of the referring oncologist was considered important in this regard: “so I think once it’s explained to people up front clearly what [palliative care] is and what benefits they can get from it, then I think they will understand it.”

Although this mixed methods study was halted early due to restrictions imposed by the COVID-19 pandemic, there are important learnings from it. Despite the small sample size and resulting lack of power, there was a tendency towards less deterioration in quality of life, symptom control, depression, and satisfaction with care in the STEP group compared to usual care. The qualitative interviews demonstrated that patients thought symptom screening was of benefit as a tool to flag issues that required further conversation with the medical team; while the triggered call by the nurse could initially be jarring, it offered an opportunity to initiate an important relationship with the palliative care team; and EPC initiated by the call provided timely additional support to improve quality of life.

Although guidelines recommend routine EPC for all patients with advanced cancer concurrent with cancer treatment,[1] patients in the STEP group were more than twice as likely to receive EPC than those who received screening alone. Our previous single-arm phase II trial of STEP demonstrated that for patients who remained screen-negative, all PRO scores were significantly better throughout the 6-month follow-up period than for those who screened positive at some point during the trial.[14] Thus the STEP intervention was able to direct EPC to patients in greatest need, while screen-negative patients maintained a high quality of life without EPC referral. STEP may provide a feasible alternative to oncologist-initiated referral that improves access for vulnerable patients without directing all patients to EPC regardless of need.

STEP utilized in-person symptom screening in oncology clinics using tablets and computers. This model of screening was abandoned during the COVID-19 pandemic, due to infection control measures and a shift to virtual visits. Instead, patients at PM are now prompted by email to complete virtual symptom screening at home, 48 hours before attending their oncology appointment. The qualitative findings regarding symptom screening have provided important information for future STEP trials. The time window for ESAS-r screening at PM has now been changed to “last 24 hours” instead of “now”, consistent with comments from this study and from a validation study for the ESAS-r-CS, in which outpatients felt this interval better accounted for symptom fluctuations.[27] In future STEP trials, the thresholds for the triggered call will be retained at the current cut-offs, based on qualitative observations that the intervention was timely, as well as symptom stability in screen-negative patients in our previous Phase II trial.[14] The content of the triggered call will focus even more on structured education about palliative care, to address common misconceptions before attending the PCC.

The EPC intervention for STEP was also delivered entirely in person in the PCC. Favourable comments by screen-positive participants that the EPC intervention provided proactive care that improved quality of life were similar to those described in previous studies,[36–38] substantiating these findings in an independent sample. The COVID-19 pandemic resulted in a rapid shift from an in-person model of palliative care to a model that was initially almost exclusively virtual.[39] Recent qualitative studies suggest that patients are in favour of a blended model of in-person and virtual palliative care delivery.[40, 41] A blended model has been adopted in our PCC and will be used for future trials of STEP.

In conclusion, the quantitative trial results demonstrated increased palliative care access and a trend towards benefit from STEP, despite the lack of power to detect statistically significant differences. The qualitative results demonstrated the acceptability of in-person STEP, and revealed opportunities to further improve upon this model. With learnings from this study, we are planning a randomized controlled trial of a blended model of in-person and virtual STEP.

ACKNOWLEDGEMENTS

Camilla Zimmermann is supported by the Harold and Shirley Lederman Chair in Psychosocial Oncology and Palliative Care, a joint Chair among the University of Toronto, Princess Margaret Cancer Centre/University Health Network and the Princess Margaret Cancer Foundation. The authors thank the patients who participated in this study, the medical oncologists who referred patients to this study, and the clinical and administrative staff of the palliative care team at the Princess Margaret Cancer Centre for their facilitation of this research.

Funding

This study was funded by the Canadian Institutes of Health Research (Grant No. 152996 to Dr. Zimmermann).

Competing interests

The authors have no competing interests to declare that are relevant to the content of this article.

Ethics approval

The study was approved by the University Health Network Research Ethics Board (REB# 19-5007). We certify that the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Consent

Informed consent was obtained from all individual participants included in the study.

Data availability statement

The data of this study are available from the corresponding author upon reasonable request.

Authors’ contribution statement

CZ: Conceptualization and design, obtaining funding, interpretation of data, writing and critical revision of the report

AP: Acquisition and interpretation of data, critical revision of the report, administrative support

BH: Conceptualization and design, interpretation of data and critical revision of the report

PLB, GR, ND, ML, LH, MKK, DH, JJK, NBL, SS, AMO, SL, CMB, GL: Interpretation of data and critical revision of the report

JAC: Interpretation of data, writing and critical revision of the report

NS: Acquisition and interpretation of data, critical revision of the report, administrative support

RSAQ: Acquisition and interpretation of data, writing and critical revision of the report

AR: Interpretation of data and critical revision of the report

LWL: Conceptualization and design, analysis and interpretation of data, critical revision of the report

All authors have provided final approval of the version to be published.

Previous presentation:

This study was presented in part at the MASCC/ISOO 2022 Annual Meeting; June 23-25, 2022; Toronto, Canada.

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No competing interests reported.

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Symptom screening with Targeted Early Palliative care (STEP) versus usual care for patients with advanced cancer: A mixed methods study

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Abstract

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Introduction

Methods

Mixed methods methodology

Setting and participants

Randomization and study arms

Quantitative and qualitative data collection

Sample size and quantitative and qualitative analyses

Results

Quantitative Randomized Controlled Trial

Qualitative findings

Symptom screening: A good starting point but not the whole picture

Triggered phone call: Initially shocked but ultimately comforted

Early palliative care: Extra support to live life to the fullest

Discussion

Declarations

References

Additional Declarations

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Journal Publication

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