Background
Cancer treatment toxicities are frequent, undesirable effects of cancer therapy that range from mild and temporary to severe, chronic, and disabling.1,2 Poorly managed treatment toxicities negatively impact quality of life (QoL) and are associated with emergency department visits and hospitalizations.3–5 Patients and families must be prepared to effectively self-manage cancer and treatment toxicities at home with minimal clinical supervision. Self-management (SM) describes patient’s behaviors and skills to manage the medical aspects of cancer and its physical and psychosocial impacts.6
Empirical evidence in chronic diseases7,8 and cancer9–11 shows that SM support (SMS) increases patients’ skills and confidence in using specific strategies to manage effects of cancer and treatment,12 improves disease control and QoL, and reduces emergency department visits. Proactive models of care improve toxicity management13; however, few studies have tested proactive SMS (education plus coaching) targeting patient activation (knowledge, skills, confidence) for feasibility and effectiveness early in cancer treatment.14–20
In this prospective, mixed-method,21 pilot randomized controlled trial (ClinicalTrials.gov identifier: NCT03849950), we evaluated the feasibility, adherence, and acceptability of the SMARTCare (Self-Management and Activation to Reduce Treatment Toxicities) intervention that combined SM online education and nurse-delivered telephone coaching. We also examined preliminary estimates of effectiveness based on patient-reported outcomes.
Methods
Participants and Recruitment Procedures
Ethics approval was obtained from the Ontario Cancer Research Ethics Board for all participating sites. Eligible patients were aged ≥18 years with lymphoma or colorectal or lung cancer initiating adjuvant or first-line metastatic chemotherapy, immunotherapy, or targeted therapy at 1 of 3 cancer centers in Ontario, Canada (Juravinski Cancer Centre, Princess Margaret Cancer Centre, and Simcoe Muskoka Regional Cancer Program). In addition, eligible patients were required to have an ECOG performance status ≤2, have access to an electronic device and the internet, and be able to complete measures and provide informed consent in English; patients were excluded if they were receiving treatment with an investigational agent.
Eligible consenting patients were individually randomized (permutated random blocks) to intervention or control groups, stratified by cancer type and center. A target sample size of 160 evaluable patients (80 subjects per arm) was set a priori, based on appropriate sample sizes for pilot trials and preliminary estimations of effect on patient-reported outcomes.22,23
Intervention
The SMARTCare intervention included 2 components: (1) a self-directed, 5-module online education program that targeted patient use of SM strategies and behaviors to manage treatment toxicities and other effects of cancer (I-Can Manage), and (2) 5 telephone-based coaching sessions delivered by oncology nurses to be completed within 4 months of treatment initiation (Figure 1A, B). SMS trained nurse coaches counseled patients to implement SM behaviors augmenting the SM online education component. Five sessions of coaching were selected based on systematic reviews of coaching effectiveness24 and demonstrated improvements in patient activation shown in an established cancer coaching program.25
(A) SMARTCare trial schema and (B) SMARTCare intervention timed across the treatment trajectory.
Abbreviations: HADS, Hospital Anxiety and Depression Scale; MSAS, Memorial Symptom Assessment Scale; PAM, Patient Activation Measure; PROMIS, Patient-Reported Outcomes Measurement Information System; SMARTCare, Self-Management and Activation to Reduce Treatment Toxicities.
Citation: Journal of the National Comprehensive Cancer Network 21, 3; 10.6004/jnccn.2022.7095
(A) SMARTCare trial schema and (B) SMARTCare intervention timed across the treatment trajectory.
Abbreviations: HADS, Hospital Anxiety and Depression Scale; MSAS, Memorial Symptom Assessment Scale; PAM, Patient Activation Measure; PROMIS, Patient-Reported Outcomes Measurement Information System; SMARTCare, Self-Management and Activation to Reduce Treatment Toxicities.
Citation: Journal of the National Comprehensive Cancer Network 21, 3; 10.6004/jnccn.2022.7095
(A) SMARTCare trial schema and (B) SMARTCare intervention timed across the treatment trajectory.
Abbreviations: HADS, Hospital Anxiety and Depression Scale; MSAS, Memorial Symptom Assessment Scale; PAM, Patient Activation Measure; PROMIS, Patient-Reported Outcomes Measurement Information System; SMARTCare, Self-Management and Activation to Reduce Treatment Toxicities.
Citation: Journal of the National Comprehensive Cancer Network 21, 3; 10.6004/jnccn.2022.7095
Oncology nurses were seconded from ambulatory clinics and received 12 hours of coaching skills training adapted from the British Columbia peer-coaching program.26 The training focused on application of the 5 A’s (assess, advise, agree, assist, arrange) behavioral counseling process to facilitate patients’ use of SM strategies to reduce treatment side effects and promote health behaviors.27,28 Coaches were instructed to contact their assigned patients before treatment initiation (introduction call and session 1 coaching), followed by a second session 7 to 14 days after first treatment dose, and then approximately monthly during the first 4 months of treatment (all sessions to be completed at 4 months), with a focus on setting a goal and action plan to manage treatment toxicities or a new health behavior at each session of 30 to 40 minutes. Coaches were supported to apply coaching skills through monthly case-based discussions with experienced coaches from an established cancer coaching program.25 Fidelity of coaching was assessed through observation of 2 sessions of nurse coaching using a standardized health coaching skills checklist.
Study Measures
Measures of feasibility were recruitment and retention, defined as the proportion of patients who agreed to participate or were approached and the proportion who withdrew or consented to participate, respectively. Adherence was defined as completion of 5 coaching sessions within 4 months and participation in the web-based program.
Electronic, validated patient-reported outcome measures were completed by patients using Qualtrics software at baseline, 2 months, 4 months, and the end of treatment (4–6 months) (Figure 1B). Activation was measured using the Patient Activation Measure (PAM),29 which evaluates knowledge, skills, and confidence for managing health across 4 levels of activation (levels 1–4) and as a total PAM activation score (range, 0–100), with higher scores indicating a higher activation level and a minimally important difference of 4 points.30 Level 1 of the PAM represents patients who lack confidence and defer condition management to their clinical team, whereas level 4 denotes adoption of new behaviors. SM self-efficacy was measured using the 8-item PROMIS (Patient-Reported Outcomes Measurement Information System) self-efficacy short form31; the total raw score was calculated by summing the value for all answered questions32 and converting it to median and interquartile range (IQR) for the summed score, which is reported. Symptom distress was evaluated using the Memorial Symptom Assessment Scale.33 Psychological distress was assessed using the Hospital Anxiety and Depression Scale (HADS)34 with a total score (ranging from 0 to 21) and as subscales for anxiety and depression. The 5-level EQ-5D (EQ-5D-5L) questionnaire was used to assess health status,35 and a self-rated perception of health was collected using a visual analog scale (VAS) ranging from 0 as worst health you can imagine to 100 as best health you can imagine. A sum score was calculated for the items in the EQ-5D-5L as a categorical variable and as median and IQR for the VAS.
Acceptability of the intervention components was assessed using a purpose-built quantitative survey (5-point Likert scale from strongly disagree to strongly agree). In addition, semistructured telephone interviews based on a qualitative descriptive approach36 were conducted with participants from the intervention, which were audio recorded and transcribed verbatim.
Analysis
Participant characteristics and outcomes were summarized descriptively; baseline differences of study completers and noncompleters were compared. A Wilcoxon rank-sum test was computed for continuous data and chi-square tests were used for ordinal data to derive a change score for outcomes at each of the measurement time points (months 2, 4, and 6 minus the baseline score) for intervention and control subjects. Generalized estimating equations for repeated measures37 were used to compare intervention and control groups on patient-reported outcomes over time using an interaction model (outcome = month + intervention + interaction) (month × intervention). All analyses were 2-sided and were conducted using SAS version 9.4 (SAS Institute Inc); significance was defined as P<.05.
Acceptability surveys were summarized using descriptive statistics, and qualitative data were analyzed inductively using content analysis to derive themes representing the data.38 Initially, 2 team members (D. Howell, T. Makuwaza) coded a minimum of 3 interview transcripts to reach agreement on codes and themes, and the remaining data were coded using NVivo by a qualitative research expert (T. Makuwaza). Final themes were decided with team input.
Results
Participants
The mean age in the overall sample was 60.5 years. Most patients were married (77.1%), college or university educated (74.2%), and had colorectal cancer (41.9%) or lymphoma (42.0%) and stage III or IV disease (75.8%) (Table 1).
Baseline Participant Characteristics
Feasibility
Of the 90 eligible individuals approached to participate in the study, 62 (76%) agreed to participate and were randomized to the SMARTCare intervention (n=30) or an enhanced education control group (clinic nurses sensitized to SMS concepts) (n=32) (supplemental eFigure 1, available with this article at JNCCN.org). We were unable to reach our target sample size of 80 per group because recruitment was halted as a result of government and hospital directives to cease research due to the COVID-19 pandemic (March 12, 2020). Our overall recruitment period was <1 year. Rates of attrition were 25% and 36.7% for the control and intervention groups, respectively. More noncompleters than completers had first-line metastatic treatment intent (47.4% vs 27.9%; P=.004), higher rates of borderline anxiety (47.1% vs 18.6%; P=.051), higher total scores for depression (median 5 vs 2; P=.008), and lower perceived health on the VAS of the EQ-5D-5L (EQ-VAS; 60 vs 80; P=.017) (supplemental eTable 1).
I-Can Manage program adherence was low, with 10 participants who never logged into the program. Coach call completion rates ranged from 51.7% to 87.5%, and was lowest for the first coaching call (51.7%), targeted for before treatment initiation (Table 2). Study protocol modifications were required because oncology nurses were redeployed to clinics as per hospital requirements due to the COVID-19 pandemic. Research team members with nursing and coaching experience (D. Howell, D. Bryant-Lukosius) completed as many of the remaining coaching calls as possible.
Intervention Coach Calls Completed
We experienced other implementation challenges. Seconding nurses from clinical care to act as cancer coaches within their clinic workflow was logistically challenging and also impacted the timing of coaching sessions delivered. In future studies, nurse coaches may need to be directly hired for the study because locum replacements are seldom available.
Preliminary Effectiveness
Change adjusted for baseline scores showed a pattern of improvement in PAM continuous and categorical levels (3 and 4) and lower anxiety and depression in the intervention group than in the control group (supplemental eTable 2). Control subjects had a decreased PAM level (45.8% vs 20.0% in intervention group) that was significant (P=.028) at 6 months. A trend toward significance in health status (EQ-VAS; P=.066) was noted with a greater decline in the control group than in the intervention group (median, −3 [IQR, −15 intervention to 5] vs 4.5 [IQR, −2 to 15 intervention]) at 2 months but not at 6 months. The intervention group had significantly (P=.012) lower median HADS total depression (−1.0; IQR, −2.5 to 0.0) than the control group (0.5; IQR, −1.0 to 3.0) at 6 months, with more control subjects increasing a level to borderline or abnormal depression (16.7% vs 0%).
In unadjusted generalized estimating equation analysis (Table 3), the continuous PAM total score (P<.001) and categorical PAM by levels (3/4 vs 1/2) (P≤.001) were significant in favor of the intervention by month (unadjusted); however, there was no interaction effect (total PAM score, P=.51; categorical PAM level, P=.36) and no effect of month (P=.14 and P=.30, respectively). HADS anxiety (P<.001) and EQ-VAS (P=.006) were also significantly different between the 2 groups by month. When adjusted for baseline values, significant differences were noted for the intervention versus control groups for continuous PAM (P<.001) and categorical PAM (P=.002) in favor of the intervention; however, there was no interaction effect and no effect of month except for the continuous PAM score (P=.015). HADS depression was significant by month (P=.037) and for interaction (P=.038) in favor of the intervention. No differences were noted for the intervention on other outcomes.
Generalized Estimating Equation (Repeated Measures) Analysis Results
An examination of the pattern of change in PAM levels over time (Figure 2) showed higher baseline PAM levels (3 or 4) in the intervention group that remained over time or improved further. In contrast, the pattern in control subjects was less stable, with 17 patients in PAM level 3 or 4 at baseline and a small number (n=5) regressing to level 1 or 2 at months 2 and 6 or staying at level 1 or 2 at each time period.
PAM levels over time, by intervention and control groups.
Abbreviation: PAM, Patient Activation Measure.
Citation: Journal of the National Comprehensive Cancer Network 21, 3; 10.6004/jnccn.2022.7095
PAM levels over time, by intervention and control groups.
Abbreviation: PAM, Patient Activation Measure.
Citation: Journal of the National Comprehensive Cancer Network 21, 3; 10.6004/jnccn.2022.7095
PAM levels over time, by intervention and control groups.
Abbreviation: PAM, Patient Activation Measure.
Citation: Journal of the National Comprehensive Cancer Network 21, 3; 10.6004/jnccn.2022.7095
Acceptability
Of the participants who completed acceptability surveys (n=20), only 12 reported use of the online program, and of these, most agreed or strongly agreed that the online intervention was easy to navigate (83%) and that information and specific module topics were relevant (92%), and most disagreed that it was burdensome (83%) and stated that they would recommend the program to other patients (92%). Similarly, most participants agreed or strongly agreed that health coaching helped them to manage symptoms and treatment side effects, helped them use health behaviors, that the number of calls was just right, and that they would recommend both online SM education and cancer coaching to other patients (supplemental eTable 3).
Thirteen patients across the 3 sites (almost equal number of males and females) participated in qualitative interviews and were mostly high school or college educated (supplemental eTable 4). Two overarching themes for both components of the intervention were identified: (1) the whole package was “perfect holistically” and facilitated better health management, and (2) goals and action planning provided a pathway to positively focus on recovery of health (supplemental eFigure 2). Themes specific to I-Can Manage were as follows: (1) comprehensive, trustworthy information helped participants know what to expect; (2) it was reassuring to know lots of strategies to manage treatment side effects, and this fostered hope of recovery and confidence; (3) the program was accessible, lay language was used, it had good layout and flow, it was easy to navigate, and strategies to manage stress and ways to improve health were helpful. Themes specific to coaching were as follows: (1) knowledgeable medical staff and caring emotional support helped guide participants through the journey, (2) strategies were shared for improving quality of life and knowing how to make things better for themselves, and (3) personalized information fostered better decision-making and medical team communication.
Discussion
Our feasibility metrics (recruitment, retention) and our target sample (n=160) were impacted by the COVID-19 pandemic. Despite this disruption, our attrition rates (25% in control group, 36.7% in intervention group) were lower than rates observed in other supportive care intervention studies in patients with metastatic disease (46%).39 Despite the small sample size and less than ideal exposure to the intervention components, a signal for improvement in patient activation in favor of the intervention was observed. This is an important finding because patient activation can impact the cancer journey, with patients in lower levels of activation (PAM level 1 or 2) less likely to communicate concerns to providers, adopt healthy behaviors, manage their symptoms, or follow their doctors’ advice.40 Patient activation has also been shown to be a significant predictor of acute care use,41 and improvement in patient activation levels correspond to changes in SM behaviors.42
I-Can Manage was codesigned with patients, caregivers, and clinicians and usability tested with patients. It was highly valued by those who used it, but uptake was low. Qualitative data revealed that earlier access to the program would be valuable, particularly for topics related to dealing with the diagnosis and talking with family. Online SM education has advantages, given the limited time that clinicians have to prepare patients with the necessary SM behaviors to manage treatment toxicities. However, uptake of online programs has been shown to be problematic, with low rates of use reported (30%), and the tailoring of information to needs43–45 may be essential to uptake of health behaviors.46,47 A number of strategies can improve adherence, including prompting online use by coaches, topic alignment with coaching sessions, participant feedback and interaction (eg, quizzes), rewards, and reminder systems to complete modules for application in the larger trial.48 Better functionality to be able to track module completion, time using a module, downloading of exercises, and completed action plans will also be important for the I-Can Manage program. We chose a pragmatic dose for the number of coaching sessions (n=5) based on a successful cancer coaching program,25 but uncertainty remains about the dose of coaching that translates into improved outcomes.49 Given the small sample size, we did not assess the effects of coaching sessions missed due to the pandemic.
Coaching for behavior change is essential with complex illnesses such as cancer, but may be challenging during acute treatment because patients are grappling with often complex side effects, emotional distress related to cancer and treatment, and changes in cognitive capacity (ie, feeling overwhelmed, brain fog) that impact participation in SM.50 Tailoring of SMS and behavior change coaching to levels of patient activation46 may also be important, given that a small proportion of patients had high levels of activation at baseline.
Nurses described coaching as a “transformational” shift from their typical role of educating patients to enabling patients to apply SM behaviors. A strength of our coach training program was the use of a case-based community of practice facilitated by a team of skilled cancer coaches to deepen nurses’ application of coaching skills. In addition, the time for training of nurse coaches (12 hours) was shorter than desired (typical training is 3 days with time between to consolidate skills), and sessions had to be repeated to accommodate nurses’ time and clinic coverage. Nurses are ideally positioned to provide cancer coaching, but system redesign is essential if they are to integrate coaching in existing workflow.51
There are some limitations to our study, including variable exposure to components of the intervention due to the pandemic. In addition, our sample was composed mostly of White participants with higher education. Qualitative interviews may not represent the views of the full sample, because only half of the intervention group participated, but there was diversity in education and gender. Some confounding may have occurred due to exposure of nurses in clinics to SM concepts in the control condition.
Conclusions
SMS that empowers patients to self-manage treatment toxicities and emotional and lifestyle consequences of cancer52–54 may improve patient activation and quality of life, but a larger trial is needed that also addresses our implementation challenges.
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