Effect of different forms of information produced for cancer patients on their use of the information, social support, and anxiety: randomised trial -- Data Supplement - Original protocol submitted to PACCIT programme for funding -- BMJ

10
. Protocol

This is an extract from the project proposal submitted to the ESRC/EPSRC People at the Centre of Communication and Information Technology (PACCIT) programme. We have omitted the introduction, team details, information about a sub study related to a web site demonstrator.

Short working protocol
Investigating the impact of tailored reports on anxiety.
Aim:

1.Based on a randomised trial we will model use of leaflets in the home as a function of three factors:

whether patients chose the information themselves or if it was chosen for them;
whether it included personal information from their own medical record or not;
whether it included anxiety management advice or not.

2. We will model patient and significant other’s anxiety at three months as a function of these three factors and patients’ use of leaflets in the home.

System:
We will produce a system which according to the randomly allocated group will create simple report with contents either (1) selected by the patients themselves or selected automatically by the system, (2) based on personal information from the patients medical record or just general information, and (3) including (or not) general anxiety reduction advice.
Patient Population:
Beatson Oncology Centre. Patients thought to be eligible will be identified from outpatient appointment diaries over fifteen months. Medical records will be checked for all those initially identified to ensure that patients have breast, gynaecological, prostate or bladder or testicular, or selected cancers of the head or neck. (If possible we will extend it to include patients with colo-rectal cancer). Patients excluded will be those: receiving palliative treatment, with no knowledge or understanding of their diagnosis (very few), with visual or mental handicap, with severe pain or symptoms causing distress, medical or nursing students, taking part in other trials with possibly confounding interventions, and those not giving informed consent. Sample size
: We aim to recruit 400 patients, 27 patients per month for fifteen months. (This will mean approaching around 600 or 40/month (ie 10 per week, at least 2 new (to the study) patients per day). This will give us 80% power to find a difference between 40% and 27% who have improved anxiety between (eg) 200 in personalised group and 200 in general group. Recruitment:
Eligible patients will be sent a letter explaining the study and advising them that a researcher will approach them in a visit to the BOC soon after, to seek participation in the study. Patients will not be recruited at their bad news consultation but as soon as possible thereafter and at any point in their course of contact and treatment at the Beatson. At recruitment the researcher will further explain the study and seek written consent. If the patient consents the researcher will arrange a time for the intervention and give the patient a questionnaire to take home to complete themselves and a questionnaire for their ‘significant other’. Baseline data:
Patients will be asked to bring the completed questionnaire with them to the intervention consultation about one week later. The questionnaire includes the following sections: (1) previous computer and information use, perceived knowledge, significant others in providing emotional support, family and living arrangements, (2) a Hospital Anxiety and Depression Scale, (3) a Miller Coping Style questionnaire, (4) Helgeson’s measures of social support and negative interactions. Completion of this questionnaire should take about half an hour at home.
Significant Others:
We aim to recruit 400 ‘significant others’, one for each patient (but are likely to recruit (say) 60% of 400. Patients will be asked if they are prepared to pass on the baseline questionnaire to a person selected by them as the person they are most likely to use to seek emotional support. This may be a husband, wife, partner, but may also be a daughter, son, or friend. The significant other questionnaire has sections: (1) demographics and relationship to patient, newspaper read, frequency of discussion with patient, perceived knowledge (2)HADS, (3) Miller coping style. We do not know what proportion of patients will be prepared to pass on the questionnaire or what response rate we will get from significant others. Rees in her work with daughters of women with breast cancer found that 93% of patients passed the questionnaires on and 77% of daughters responded. If we get an overall 60% response (ie 240 before and after questionnaires) this will give us 80% power to find a difference between 40% and 23% who have improved anxiety between (eg) 120 in personalised group vs 120 in general group. The significant other population will be less than the patient population. Patients will not be excluded if there is no corresponding ‘significant other’. Randomisation for the three factors:
After recruitment the RA will randomise for each of the three binary factors (2X2X2 factorial design): A. Interactive v Automatic; B. Medical Record v General; C. Anxiety reducing advice v no advice. Patients will be randomised to the eight sub-groups in blocks of 32 and separately by breast vs rest. The eight (2X2X2) subgroups, each receive different styles of leaflet. These are detailed further below. Baseline Data:
Collected from case notes will be severity, length of onset of cancer, treatments so far (surgery, radiotherapy, chemotherapy), date of birth, gender, address, deprivation category from postcode for all patients, and a problem and treatment list for patients in the ‘medical record’ groups. Intervention:
The delay between recruitment and intervention allows patients time to think about their participation and withdraw if desired. At the intervention, patients will produce a report about their cancer. Patients in the ‘automatic group’ will not need to use the computer.

Interactive vs automatic. Those in the ‘interactive’ groups choose from menus, see information on the screen, and press an ‘add to report’ button on information screens for that information which they want to include in their report. Patients’ choices will be recorded by the computer.
Those in the medical records group will have personal information included based on their medical record. They will either have information automatically selected and formatted by the computer, or may see it on screen and choose what they want to include.
Lastly, half the patients will have an additional section offering advice for the reduction of anxiety. This section has been written based on previous work in cognitive behavioural therapy for anxiety.

All reports will include colour photos (for example of treatment rooms, staff), and diagrams (for example, anatomical) , good quality printing etc. The patient will be given the report to take away.

Three month follow-up:
At three months patients will be sent a follow-up questionnaire with the following sections (1) questions about their satisfaction with the information received, their use of their reports, their interactions with their family and friends, and the influence of the reports on these interactions, their perceived knowledge. (2) HADS, (3) Helgeson’s social support questionnaires. Significant others will be sent a questionnaire which has sections on (1) questions about their satisfaction with the information they have received. (2) HADS
Measures of Outcome:

Change in anxiety (for patient or SO) between intervention and 3 month follow-up (HADS)
Change in social support (for patient) between intervention and 3 months (Helgeson)
Patient satisfaction with information score at 3 month follow-up
Significant other satisfaction with information score at 3 month follow-up
Whether patient had read report, shown it or discussed it with the named significant other, other family members or friends and whether the discussion was aided by use of the report.
What patients liked and disliked about the reports.
Amongst the interactive group, choices made between presentation styles and how well these would correspond to automatic computer choices.
Patient and staff time, and hence costs, needed for routine delivery of each intervention will be modelled on a variety of assumptions.

Analysis

Comparison of outcomes 1-4 by interventions A, B, and C while controlling for age, gender, cancer site, time since diagnosis, severity, coping style, using analysis of variance (factorial design) and multiple logistic regression.
Comparison of outcomes 5 and 6 by interventions A,B, and C (qualitative).
Modelling of anxiety (outcomes 1-2) on use of report at home (outcome 4), perceived social support, and interventions A,B,C.
Frequencies of choices (outcome 7) and comparison with automatic selection, both statistically and through qualitative description of the differences.
Comparison of patient and NHS costs (outcome 8) will be made between the methods used in this trial and other methods of providing information.
Comparison of anxiety change in patient and significant other.
Analyses will be on those completing follow-up. No substitution of data will be carried out for those randomised but not completing follow-up. We will thus be able to make provisional conclusions on how the different types of information provision influence interaction, anxiety and patient satisfaction, and on the correlation between the use of information with family, and anxiety; We will have information on patient selection to inform the better development of automatic systems, and costs to inform practical deployment.