Effectiveness of a training program for healthcare professionals on parental cancer: Results of a randomized controlled pilot‐study

Cancer patients parenting minor children face specific burden and supportive needs, which are often not adequately addressed by their healthcare professionals (HCPs), due to a lack of knowledge, self‐efficacy and competencies. Therefore, we developed a 3‐h intervention enhancing HCPs' competencies in caring for these patients. We pilot‐evaluated the intervention's feasibility and efficacy, assuming intervention group participants reveal higher improvements over time compared to non‐trained participants.


| INTRODUCTION
Parents with cancer are not only affected by disease-related burden, but also by concerns and fears regarding their children and their role as a parent. 1 As the parental cancer diagnosis impacts the whole family, minor and young adult children are confronted with changes in daily routines and reduced physical and emotional availability of their parents. 2Between 7% and 88% of affected parents show substantially increased depression or anxiety levels. 3Though most children cope well with the challenging situation, they are at risk to develop behavioral or emotional problems during the course of a parental cancer disease and its treatment. 4,5Patient-and familycentered care is key to enhance high quality cancer care and must involve family and friends as a sixth dimension in patient-centered care. 6However, children as relatives are often overlooked within the healthcare system and therefore may not receive the necessary support. 7,8Affected parents wish for information and support in parental issues by their healthcare professionals (HCPs) (e.g., how to communicate with children), [9][10][11] but feel uncertain how to express their concerns and needs as a parent. 9HCPs serve as gatekeepers by identifying cancer patients with minor children, their specific needs and worries and -if necessary-initiate supportive psychosocial care. 9 Germany, national guidelines explicitly mention that all members of the oncological healthcare team are (to varying extents) responsible for the psychosocial care of patients, including for example, physicians or nurses. 12,13Nevertheless, HCPs rarely address childand family-specific themes proactively in daily routines. 8,10,14,157][18] As competencies do not change with experience alone, 19 considerable effort is needed to increase HCP's knowledge, skills and self-efficacy regarding child-and family-related themes in cancer care.Despite the high need, 20,21 only few studies developed and evaluated specific interventions for HCPs on the subject of parental cancer. 14,20nce, we developed an interprofessional 3-h educational training for HCPs in oncology to enhance their competencies in caring for cancer patients parenting minor children. 20Training was either delivered as a face-to-face training (F2F) or a self-directed e-Learning (EL).This study aims at investigating: (1) the feasibility of both training formats and the evaluation concept, and (2) the preliminary effectiveness of the training regarding primary and secondary outcomes.
We hypothesized both intervention groups exhibiting significantly higher outcome improvements from baseline to post-training compared to waitlist-control group (CG).

| METHODS
The study was registered within the German Clinical Trial Register (DRKS-00015794) and approved by the Local Psychological Ethics Committee of the Center for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Germany (LPEK-001).

| Study design
This study was conducted as a randomized controlled pilot-trial (pilot-RCT) at the Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Germany. 20Study groups (F2F, EL, CG) were compared regarding improvements over time in primary and secondary outcomes at three time points: before (t0, baseline before randomization), after (t1, post-training) and at 3month follow-up (t2) (Figure 1).

| Intervention
Development and detailed content of the training are described elsewhere. 22The training comprised three modules (Figure 2), focusing on the disease's impact on the family, children's reaction to parental disease and the communication within and with families.For more information on training content, see Supporting Information S1. -1569

| Outcome measures
The training's pilot-evaluation was based on three levels of the Kirkpatrick's model of program evaluation: reaction (cf.Aim 1, feasibility and trainings satisfaction), learning and behavior (cf.Aim 2, preliminary effectiveness of the training). 23Beyond feasibility and effectiveness, we assessed sociodemographic information, jobrelated fulfillment and burnout.

| Preliminary effectiveness: Primary outcome
Primary outcome was the competency to approach child-and familyrelated themes in cancer patients.We developed a specific assessment tool, combining clinical case vignettes and situational judgment test methodology. 24Each questionnaire included two clinical scenarios, reflecting cases of parents with cancer and measuring four domains: (1) transfer of knowledge into clinical practice, (2) empathic behavior toward affected parents, (3) integration of child-and familyrelated themes into clinical practice (behavior) and ( 4) perceived relevance of integration.Participants rated their behavior and its perceived relevance on a 4-point Likert-Scale.A pre-developed scoring guide was used to assess open responses in the domains of knowledge transfer and empathy.Answers were rated independently by two researchers (LJ, WF), and discussed in case of discrepancy.Across both scenarios, possible total score ranged from 0 to 14 for knowledge transfer and from 0 to 4 for empathy.Sum scores for knowledge transfer and empathy and mean scores for behavior and relevance were calculated across both scenarios of one measurement point.

Self-efficacy
Participant's self-efficacy was assessed using an adapted questionnaire (SE-12-G) with two subscales (confidence in [scale 1] and importance of communication skills [scale 2]).The original version (Self-Efficacy of Communication Skills scale, SE-12) was translated into German following the TRAPD translation protocol 25 and adapted for this study. 26To assess self-efficacy in child-and family-specific communication skills and related attitudes with the same two subscales (confidence-and importance-scale), we constructed five additional items (SE-fam) based on a previous, adapted SE-12 version. 27Items of the confidence-scale were rated on a 10-point rating scale ("How certain are you…"; 1: very uncertain to 10: very certain) and items of the perceived importance-scale on a 5-point-Likert-scale ("How important is it…"; 1: not important at all to 5: very important), with an additional check box "not relevant."The original SE-12 revealed acceptable test-retest reliability and high internal consistency and ceiling effects in 9 of 12 items. 26

Communication behavior
HCPs' behavior regarding child-and family-related themes in their daily practice was assessed by 15 self-developed items (e.g., "How often do you ask cancer patients/relatives about their concerns or worries as a parent?") using a 4-point Likert scale (1: never to 4: always).

Professional fulfillment
To assess HCPs professional fulfillment and burnout, we translated the Professional Fulfillment Index (PFI) 28 into German applying the TRAPD translation protocol. 25The 16-item questionnaire comprises three main scales (1) professional fulfillment, (2) work exhaustion and (3) interpersonal disengagement as well as an overall burnout scale.The overall burnout scale was used as a covariate within the main analysis.
Items were rated on a 5-point Likert scale (0: not at all to 4: completely true/extremely).The original PFI revealed good internal consistency and test-retest reliability with an adequate sensitivity of all scales. 28

| Sample size calculation
We used an approach for pilot studies to determine the sample size. 29As a 10% probability for an unforeseen problem to occur and a 95% confidence interval (CI) to detect these problems was assumed, a necessary sample size of n = 30 participants in each study group was calculated.Considering a drop-out rate of 30%, n = 108 participants (n = 36 per group) were aimed to be included in the study.
Drop-out was defined as not sending back the respective questionnaires despite three reminders.satisfaction including between-group comparisons (F2F vs. EL).

| Statistical analyses
ANOVA and chi-square tests were used to analyze differences between study groups at baseline (e.g., age, gender).Drop-out analyses were performed to analyze differences between completers and noncompleters regarding sociodemographic and job-related baseline characteristics.We used linear mixed model analyses with repeated measures to compare outcome improvements between study groups over time.This method accounts for missing values conditional on the information available in the model. 30Following a guideline on the adjustment for baseline covariates, 31 we calculated mixed models using change from baseline (CFB) values as outcome, study group, time, HCP group and the interaction term of "study group � time" as fixed main effects, and age, sex, overall burnout score and the outcomes' baseline values as covariates.To model interindividual differences, we included random intercept.We set the hierarchical model assuming a heterogeneous autoregressive covariance structure of residuals.Due to the small number of social workers and resulting unbalanced group sizes, we merged the groups of social workers and other professions for mixed model analyses into one group.

| Training satisfaction
Overall, participants were highly satisfied with both training formats and there were no significant differences between the F2F and EL participants (cf.Supporting Information S3).Post-training, participants generally rated both formats as highly supportive, feasible and acceptable.For additional information on format-specific satisfaction and satisfaction at t1 and t2, see Supporting Information S4.
Regarding the feasibility of the evaluation concept, high response rates of questionnaires and small numbers of missing values indicate the instruments being usable and feasible.

| Aim 2: Preliminary effectiveness of the training
Observed outcome values and results of mixed model analyses for primary and secondary outcomes are presented in Table 2.Primary outcome.Regarding the competency to approach child-and familyrelated themes, analyses indicated no significant differences over time between study groups in any of the four competency domains (knowledge transfer, empathy, behavior, relevance).Secondary outcomes.Analyzing improvements of knowledge about child-and familyspecific themes, F2F showed significantly higher improvements than CG from t0 to t1 and greater improvements than EL when comparing t0 and t2.Results on self-efficacy in communication skills (SE-12-G) indicate F2F and EL being superior to CG (when comparing t0 and t1).Regarding self-efficacy in child-and family-specific communication skills and related attitudes (SE-fam), results on the confidence-scale also indicate F2F and EL being superior to CG (over all 3 measurements).Regarding results on the perceived importance-scale, F2F and EL showed greater improvements compared to CG from t0 to t1, comparing baseline with t2, effects only appeared in F2F (see Table 2 for further results).
Regarding HCPs' communication behavior about child-and familyrelated themes in daily practice, intervention groups significantly improved over time compared to CG in various items, for example, asked more frequently about children, children's age, patients' emotional burden, and talked more frequently about children's possible reactions or specialized support offers (cf.Supporting Information S5).

| DISCUSSION
We evaluated the effectiveness of a training for HCPs on parental cancer by comparing a F2F with an EL and a waitlist-control group (CG).Participants rated both training formats as highly satisfying and feasible.Furthermore, low drop-out rates and low numbers of  18 Enhancing HCPs in their knowledge and self-efficacy around child-and family-related themes may support early identification of specific needs and facilitates referral to family-support offers for affected families. 9,32,33r results indicate comparable preliminary effectiveness of both training formats as overall F2F participants do not show higher improvements compared to EL participants.However, higher dropout rates and participants' feedback indicate higher preference for the F2F format (cf.Supporting Information S4d).At the same time, HCPs experience various barriers in daily clinical routine to participate in a F2F intervention, for example, time constraints. 34EL might be an adequate alternative to F2F, as it is a more flexible approach. 34 evidence for EL interventions on patient-reported outcomes is low, 34 >11 years 59 (  an approach considered to be more precise, but variance may be limited and effects may be underestimated. gists) or work experience in oncology were recruited by e-mail or mail in North Germany from September 2019 to April 2021.During the Covid-19 pandemic, HCPs were recruited nationwide via email.Since we recruited via existing networks and lists and recipients were encouraged to forward study information to other HCPs, we cannot estimate the overall cohort number or number about decliners.All participants gave written informed consent before completing the baseline questionnaire.Physicians, psychologists, and nurses received continuing education credits for training participation.After the baseline assessment (t0), participants were stratified by their profession and randomly assigned to study groups.Post-training assessment (t1) was conducted 2-3 weeks after training participation (F2F), 6-8 weeks after sending EL access data, or 6 weeks after returning the baseline questionnaire (CG).Follow-up assessment (t2) was conducted 3 months after training participation (F2F) or 3 months after returning t1 (EL, CG).CG participants were offered to participate in a training of their choice (F2F or EL) after t1 assessment.

The 3 -
h training program was delivered either as a F2F format with a maximum of 8 participants or as a self-administered EL program.Due to COVID-19 pandemic and related contactrestrictions in Germany starting in March 2020, original F2F was adapted to an interactive web-based F2F (≤8 participants).Both F2F training formats were conducted interprofessionally, applied various didactic methods (e.g., lectures, discussion rounds, audiovisual material and experience exchange) and were conducted by two facilitators.Two trainers have a psychological (LI, LMJ) and one trainer has a health science background (WF).EL participants received access using a code and could work stepwise through the training by buffering the training success.In the EL, various didactic methods were used, such as quiz rounds, matching, selfreflection exercises and audio-visual material (comparable with F2F format).F I G U R E 2 Content of the developed training program.F I G U R E 1 Study enrollment according to the Consolidated Standards of Reporting Trials (CONSORT) 2010 flow diagram.JOHANNSEN ET AL.

2. 4 . 1 |
Feasibility: Participants' training satisfaction Feasibility and acceptability of the training were assessed using selfdeveloped items.General items referring to both training formats were complemented by format-specific items and items on general format preference, rated on a 4-point Likert-scale (1: I do not agree at all to 4: totally agree).

Knowledge
To assess specific knowledge on child-and family-related themes, we developed eight items based on training content (e.g., patient's barriers to use support offers).Two raters (LJ, WF) independently assessed participants' answers based on a pre-developed scoring guide (maximum score of 17.5 points).
Descriptive statistics were used to analyze sample characteristics and participants' expectations and training motivation.Nonparametric tests were used to analyze participants' training 1570 -JOHANNSEN ET AL.
162 participants gave their informed consent for participation.Of these, 152 returned the baseline assessment and were randomly assigned to F2F (n = 52), EL (n = 48) or CG (n = 52).Study groups did not differ significantly regarding participants' baseline sociodemographic variables.Drop-out analyses did not show any significant baseline differences between completers and non-completers.Across all study groups, 27 individuals dropped out between baseline and follow-up with a significant higher dropout in EL (n = 15) compared to F2F (n = 6) or CG (n = 6).Participants' reasons for dropout were for example, no reply despite three reminders (n = 15), technical problems with EL (n = 4) or no suitable date for F2F participation (n = 3).
JOHANNSEN ET AL. -1571 missing values indicate high acceptability of both the trainings and the applied evaluation measures.While the training did not significantly increase participants' competencies to address child-and familyrelated themes over time compared to CG, analyses indicate significant positive intervention effects over time for secondary outcomes, mainly for self-efficacy in communication skills (including child-and family-specific communication skills) and communication behavior about child-and family-related themes in daily practice.Our results are in line with two previous studies indicating improvements in communication skills, knowledge and self-efficacy after participation in a training for HCPs on parental cancer. 14,20However, results should be interpreted with caution due to self-reported measures, as findings indicate a positive shift to a more proactive and patientoriented behavior after training.Since analyses revealed positive intervention effects in knowledge, self-efficacy and communication behavior, training might contribute to reduce barriers of HCPs (e.g., lack of knowledge and self-efficacy) and promote a proactive and patient-oriented communication with affected parents.
the pros and cons of EL interventions should be considered carefully when designing trainings for HCPs.Still, location independent training formats, including self-directed EL and web-based livetraining, play an important role in providing education, especially during the COVID-19 pandemic.T A B L E 1 Sample characteristics at baseline (t0, n = 152).

Amount of cancer patients per 2
Abbreviations: CG, waitlist-control group; EL, e-learning; F2F, face-to-face training; M, mean; SD, standard deviation.a Multiple answers possible.

4. 2 |
Clinical implicationsIdentifying cancer patients with minor children and assessing their specific supportive needs is imperative for HCPs to provide adequate cancer care and, in a best practice scenario, refer families in need to family-or child-centered support programs or services.32,[36][37][38][39]Our findings indicate that a 3-h-training on parental cancer can increase HCPs' knowledge and self-efficacy.It thus has the potential to improve the situation of affected families by enhancing the HCPs' self-efficacy to address the needs of affected parents (e.g., how to communicate with children about cancer).The training might be complemented by routine screening for patient and family needs as well as the implementation of family-and childcentered support programs or services.32,[36][37][38][39]As HCPs have different professional backgrounds and experiences, their needs regarding intensity and length of the training might differ.Therefore, an adaptation specifically tailored to the different HCP groups might be advantageous to deepen specific knowledge and skills within the different professions.5 | CONCLUSIONSFindings of our pilot evaluation of a training for HCPs on parentalcancer indicate no improvements in the competency to approach childand family-related themes after training, but improvements on knowledge, self-efficacy, and family-oriented communication of HCPs.To ensure long-term improvements in HCPs' knowledge, self-efficacy, and family-oriented communication, "refresher courses" after basic training might be a suitable approach.Participants were highly satisfied with both training formats.Although EL seems to be an adequate alternative to F2F, enabling time-and location-independent education, participants mainly preferred F2F.Overall, findings indicate the training being a promising and feasible approach to enhance HCPs' knowledge and self-efficacy in caring for parents with cancer.Further research is needed to verify the preliminary findings of this pilot-study.

Descriptive data per study group CFB Pairwise group comparisons Global effect interaction b
or the perspective of patients as an outcome parameter for the effectiveness of a training for HCPs and to investigate how patients and children perceive interactions with HCPs after attending a training.Additionally, we used linear mixed models including the outcomes' baseline values as a covariate, Note: Bold font indicates statistical significance.a n = 52 (F2F), n = 48 (EL), n = 31 (CG); sample sizes slightly differ, as single items were not answered by all respondents.b Global effect as interaction between study group (F2F, EL, CG) and time (T0, T1, T2).Results are expressed as mean (M), standard deviation (SD), mean difference (M diff ), confidence interval (CI), change from baseline (CFB), p-value (p).*p < 0.05; In the mixed model analyses following variables were set as fixed main effects: study group, time, HCP group and the interaction term of study group � time.Age, sex, overall burnout score and the outcome's baseline values were included as covariates.1574 -