The primary outcome measure to assess efficacy of Oncokompas is patient activation. Secondary outcome measures include self-efficacy, personal control, perceived patient-physician interaction, mental adjustment to cancer, need for supportive care and HRQOL. Furthermore, cost-utility outcomes will be assessed. Reach is defined as the percentage of cancer survivors who get access to Oncokompas within the context of this RCT. To obtain insight into possible factors associated with reach, we will obtain data on socio-demographic and clinical characteristics, health literacy, health locus of control (HLC), Internet use, attitude towards eHealth and the outcome measures on efficacy.
Efficacy
Personal control
The Pearlin Mastery Scale (PMS) measures global sense of personal control. It consists of seven items, and individuals respond to a 5-point Likert scale about the extent to which they agree (5 = strongly agree) or disagree (1 = strongly disagree) with the various statements. A PMS score ranges from 7 to 35, with a higher score reflecting greater mastery [
23].
Perceived patient-physician interaction
The five-item Perceived Efficacy in Patient-Physician Interactions measures patients’ confidence in interacting with their main care provider using the short five-item version of the scale. Patients can indicate on a 5-point Likert scale (1 = not at all confident to 5 = completely confident) how confident they are that they, for example, know which questions to ask or are able to make the most out of their care provider visit [
24,
25].
Need for supportive care
The 34-item Short Form Supportive Care Needs Survey (SCNS-SF34) measures the need and level of need for supportive care in the last month on the basis of 34 items using a 5-point, two-level response scale. The first response scale consists of two broad categories of need: ‘no need’ and ‘a need’. The ‘no need’ scale is further subdivided into ‘not applicable’ for issues that are not a problem to the patient and ‘satisfied’ for issues on which a patient needs support but the support is satisfactory. The ‘need’ category has three subcategories indicating the level of need for additional care: ‘low need’, ‘moderate need’ and ‘high need’ [
26,
27].
In conjunction with SCNS-SF34, a tumour-specific module for patients with head and neck cancer can be used. The SCNS-HNC measures the need for supportive care concerning 11 HNC-specific issues using the same response scale as the SCNS-SF34 [
28].
Mental adjustment to cancer
Cognitive and behavioural responses to cancer diagnosis and treatment are determined using the Mental Adjustment to Cancer scale (MAC). The MAC comprises five subscales: Fighting Spirit, Helplessness/Hopelessness, Anxious Preoccupation, Fatalism and Avoidance. The 40 items are rated on a 4-point Likert scale ranging from 1 for ‘definitely does not apply to me’ to 4 for ‘definitely applies to me’. A higher score represents a higher endorsement of the adjustment response [
29].
Health-related quality of life
The 30-item core European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a cancer-specific quality-of-life questionnaire developed for repeated assessments within clinical trials. It was developed in a cross-cultural setting and is a valid and reliable instrument for quality-of-life assessments in various cancer populations. It contains five functional scales (physical, cognitive, emotional, social and role), a global quality-of-life scale, three symptom scales (pain, fatigue and nausea/vomiting) and six single items (dyspnoea, insomnia, loss of appetite, constipation, diarrhoea and financial difficulties). All scales and single items range in score from 0 to 100. A higher score on one of the functioning scales or the global quality-of-life scale represents a better quality of life, whereas a higher score on the symptom scales or the single items indicates a higher level of symptoms [
30,
31].
In conjunction with the EORTC QLQ-C30, tumour-specific modules can be used. EORTC QLQ-BR23 is a module meant to be used among patients with breast cancer, varying in stage of disease and treatment. It consists of four functional scales (body image, sexual functioning, sexual enjoyment and future perspective), three symptom scales (systemic therapy side effects, breast symptoms and arm symptoms) and one symptom item (distress caused by hair loss) [
32].
EORTC QLQ-CR29 is a module meant to be used among patients with colorectal cancer. It includes two functional scales (body image and future health perspective) and five symptom scales (micturition problems, gastrointestinal problems, defecation problems, sexual problems and chemotherapy-related problems) [
33].
EORTC QLQ-H&N43 is a module meant to be used among patients with head and neck cancer. It contains 13 symptom scales (pain, swallowing, senses, speech, social eating, social contact, physical contact, skin, shoulder, body image, teeth, dry mouth and sticky saliva, and anxiety) and 6 symptom items (trismus, cough, lymphedema, wound healing, neurological problems and weight) [
34].
EORTC QLQ-HL27, EORTC QLQ-NHL-LG20 and EORTC-QLQ-NHL-HG29 are modules meant to be used with patients with Hodgkin’s lymphoma, low-grade non-Hodgkin’s lymphoma and high-grade non-Hodgkin’s lymphoma, respectively. All modules have four multi-item scales, but they differ in the number of items per scale: symptom burden due to disease and/or treatment (4–7 items), physical condition/fatigue (4 or 5 items), emotional impact (4–6 items), and worries/fears health and functioning (8–11 items), with an extra item scale on neuropathy (2 items) for EORTC QLQ-NHL-HG29. For all scales, a higher score reflects worse or more symptoms/problems.
Outcome measures on cost-utility
A cost-utility analysis will be conducted; that is, the difference in total 6-month costs between the two arms will be compared with the difference in quality-adjusted life-years (QALYs) based on the 5-dimension EuroQol questionnaire (EQ-5D). The EQ-5D consists of five items measuring problems in five dimensions of quality of life (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Patients can answer that they have no problems, some problems or extreme problems [
35]. The resulting profile of answers (1 of 243 possibilities) can be transformed to a value given by the general public: the EQ-5D index using the Dutch index tariff [
36]. Furthermore, a visual analogue scale is included, which represents the patient’s judgment of his or her own health state on a scale from 0 (worst health state) to 100 (best health state).
Direct medical costs (healthcare and medication use), direct non-medical costs (travelling costs and help received from family or friends) and indirect non-medical costs (productivity losses) in the previous 3 months will be measured using an adapted version of the Institute for Medical Technology Assessment Medical Consumption Questionnaire (iMCQ) [
37] and Institute for Medical Technology Assessment Productivity Cost Questionnaire (iPCQ) [
38] of the Institute for Medical Technology Assessment (iMTA) of Erasmus University Rotterdam (Rotterdam, The Netherlands). In addition, a case report form on healthcare use in the hospital during the study period, including medical specialist visits, day treatment and hospital admission, will be completed using the hospital information system.
Reach
Reach is defined as the percentage of cancer survivors who get access to Oncokompas within the context of this RCT. More precisely, reach is the percentage of cancer survivors who are willing to participate in the second part of the study and thereby get access to Oncokompas (directly or after 6 months). For the numerator, cancer survivors who are willing to participate in the second part of the study and give their informed consent will be counted. For the denominator, all eligible cancer survivors who are invited to participate in the first part of the study will be counted.
Participants who complete the baseline questionnaire will be asked to participate in the follow-up study. To obtain insight into reasons for non-participation, participants not interested in the follow-up study will be asked to indicate their reasons for non-participation in the second part of the study (e.g., no interest in scientific research or no interest in the eHealth self-management application Oncokompas) by means of multiple-choice questions.