Primary, secondary and moderator outcomes are assessed using online self-report questionnaires. Baseline questionnaires are completed upon enrolment/ prior to randomisation. Post treatment questionnaires are completed at the conclusion of the sixth module (seven weeks after completing the baseline survey), and follow-up questionnaires are completed approximately 3 months and 6 months after treatment completion.
Primary outcome: distress
The primary outcome for this study is distress, measured as general distress and as cancer-specific distress. General distress is measured using the total scale score of the 21-item Depression Anxiety Stress Scale – short form (DASS: [
33]), which assesses levels of anxiety, depression and stress over the previous week on a four-point scale ranging from (0) Did not apply to me at all to (3) Applied to me very much, or most of the time. Cancer-specific distress is measured using the 17-item Posttraumatic Stress Scale-Self Report [
34], which measures on a 4-point scale (
0 = Not at all or only one time, 3 = 5 or more times per week / almost always), the severity of each DSM-IV post-traumatic stress disorder symptom criterion in terms of how often respondents experienced each symptom in the previous week. For this study, the measure was adapted in order to reflect cancer diagnosis as the stressor.
Secondary outcomes
Secondary outcomes for this study include Health-Related Quality of Life (HRQOL), coping, and the economic impact of the intervention in terms of Health Service Utilisation. HRQOL is measured using the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire [
35], a 30-item comprehensive health related quality of life assessment for cancer patients which yields a global QOL score, and five functional subscales (physical, emotional, social, role, cognitive).
Coping is measured with the mini-Mental Adjustment to Cancer Scale (mini-MAC: [
36]), a 29-item scale yielding 5 factors: Fighting Spirit, Helplessness/Hopelessness, Anxious Preoccupation, Fatalism, and Cognitive Avoidance. Items are responded to on a 4-point scale ranging from ‘
definitely does not apply’ to ‘
definitely does apply’.
Health Service Utilisation is examined using the 17-item Health Service Utilisation Questionnaire [
37], which assesses health service use in the previous 12 months in terms of whether patients have been hospitalised and the number of visits to doctors and other health professionals. Hospitalisation is indicated as
no/
yes day only/
yes spent at least one night (with number of days then recorded). Visits to GPs/hospital doctors/specialist doctors are indicated on a 7-point scale ranging from
none to
25 or more times, and utilisation of other health professionals (e.g. physiotherapist) is indicated as
yes or
no.
Moderators of outcomes
Participant and medical characteristics, availability of social support, information-seeking preferences, emotion regulation, vulnerability to cancer-distress, adherence to the program, and participant satisfaction are assessed as postulated moderators of program efficacy.
Participant and medical characteristics are assessed at baseline only, and consist of age, marital status, occupational status, annual gross income, level of educational attainment, area of residence (rural/urban, state), ethnicity, cancer type, time since diagnosis, treatment received (surgery, chemotherapy, radiotherapy, hormonal therapy, other), any other chronic health conditions, and other support-services accessed.
Availability of social support is assessed using the 20-item Medical Outcome Study Social Support Survey [
38], which consists of four subscales: emotional/informational, tangible, affectionate, and positive social interactions, with availability of the support type listed in each item rated on a 5-point scale (
1 = none of the time, 5 = all of the time).
Information seeking preferences in terms of the type and amount of cancer information sought by patients is measured by the Miller Behavioral Style Scale scale [
39]. This scale identifies information seekers who look for and amplify threat-related cues (monitors) and distracters who avoid and minimize such cues (blunters), and has been used extensively in cancer populations. The scale asks the respondent to imagine two stress-evoking scenarios, each of which is followed by eight statements that describe different ways of coping with the stressor, with four statements being of a monitoring or information-seeking variety and four of a blunting or information-avoiding variety. Respondents are asked to check all statements that apply to them.
Vulnerability to distress is assessed using the Difficulties in Emotion Regulation Scale [
40], a 36-item measure of difficulties in emotion regulation across six dimensions, namely a) lack of awareness of emotional responses, b) lack of clarity of emotional responses, c) non-acceptance of emotional responses, d) limited access to emotion regulation strategies perceived as effective, e) difficulties controlling impulses when experiencing negative emotions, and f) difficulties engaging in goal-directed behaviours when experiencing negative emotions. Participants respond to each item on a 5-point scale (
1 = almost never, 5 = almost always).
Adherence to the study is measured in two ways. First, the self-help compliance scale [
41] measures participant self-reported engagement with program’s (i) information, (ii) worksheets, and (iii) weekly time usage. Second, website use indicators are tracked on the website itself, including: number of visits, length of time logged in, and number of modules and worksheets completed.
Finally, levels of satisfaction with the website will be assessed as a measure of whether this intervention improved psychosocial support for patients. Qualitative feedback will be gathered within the website, and at follow-up assessments.