Background
Patient reported outcome measures (PROMs)
Electronic and mobile reporting technology
eRAPID development work
-
Successful mapping of current systemic treatment pathway, establishing where eRAPID is best placed
-
Identification of staff requiring training to deliver eRAPID
-
Adaptation of a health economic questionnaire for cancer patients receiving treatment
The eRAPID intervention
-
Patients can log in to QTool (using a unique username and password) to access the eRAPID symptom questionnaire anywhere with internet access (including home or hospital).
-
For mild/moderate problems information about self-managing these issues are provided via brief instructions in QTool along with hyperlinks to more detailed advice on the eRAPID patient website (Fig. 2a).
-
Where severe symptoms are reported patients are advised to contact the hospital.
-
The patient reported data is immediately available for staff to view in the individuals’ electronic patient records in Leeds Teaching Hospitals NHS Trust (Patient Pathway Manager, PPM). See Fig. 2b.
-
Alerts for severe symptom reports are sent directly to staff via email. Clinicians can then log into PPM and view the patients’ symptom reports and take appropriate action where needed.
Hypotheses
-
Benefits for patients
-
○ Earlier symptom detection and improved self-management, timely admissions
-
○ Improved supportive medication use
-
○ Appropriate hospital, GP, community contacts
-
○ Better outcomes (improved symptom control, functioning and quality of life)
-
-
Benefits for staff
-
○ Reduce the number of hospital, GP, community contacts
-
○ Save time spent on enquiring and recording AEs
-
○ Focus attention during clinical contacts on most important or severe AEs
-
○ Support decision making in routine care
-
-
Benefits to the NHS
-
○ eRAPID provides a cost-effective approach to support patient self-management and reduce hospital and GP contacts
-
Study design
Patient sample
Methods
Usual care
eRAPID intervention
Aims and study objectives
Ethical approval
The RCT has two phases
Internal pilot phase
Patient eligibility
Inclusion criteria
-
Adult patients (aged 18 years or over) attending St James’ Institute of Oncology, Leeds with breast cancer undertaking either neo-adjuvant or adjuvant systemic treatment pathways, gynaecological or colorectal cancer requiring chemotherapy
-
Prescribed at least 3 months of planned chemotherapy cycles at the time of study consent
-
Able and willing to give informed consent
-
Able to read and understand English
-
Access to the internet at home
Exclusion criteria
-
Taking part in other clinical trials involving the completion of extensive patient reported outcome or quality of life measures or have previously participated in an eRAPID trial
-
Exhibiting overt psychopathology/cognitive dysfunction
Recruitment processes
Identification of eligible patients
Approaching patients
Randomisation
eRAPID intervention: Participant and staff training
Participant training
Staff training
Outcome measures
Questionnaire title and brief description | Item information/response format and scoring | Example questions | Time points |
---|---|---|---|
Primary outcome- Quality of Life | |||
Quality of life: FACT-G [36] | |||
27 item cancer specific QOL measure four subscales covering physical, social or family, emotional and functional wellbeing | 5 point scale (0 not at all – 4 very much) | • I have nausea | Baseline, 6, 12, 18 weeks and 12 months |
• I am forced to spend time in spend | |||
Higher subscale and total scores indicate better QOL (score range 0–108). | • I get support from my friends | ||
• I worry that my condition will get worse | |||
• I have accepted my illness | |||
Secondary outcomes- health economic/clinical process data | |||
EQ-5D-5 L [38] | |||
6 item descriptive health profile (measuring mobility, self-care, usual activities, pain, anxiety/depression) and a single index value for health status that can be used as part of a health-economic evaluation. | 5 items measured on 5 point scale and single global health item rated from 0 (worst health) to 100 (best health) | Self-care | Baseline, 6, 12, 18 weeks and 12 months |
• I have no problems washing of dressing myself | |||
• I have slight problems washing or dressing myself | |||
• I have moderate problems washing or dressing myself | |||
• I have severe problems washing or dressing myself | |||
• I am unable to wash or dress myself | |||
Use of Resources | |||
Assessment of financial impact of cancer treatment covering: | Varied tick boxes and free text options. | • Please complete the boxes below to tell is about any non-hospital health care contacts you have had in the last 6 weeks | 6, 12, 18 weeks and 12 months |
- Employment status | |||
- Contacts with community health care services (GP, district nurses etc) | |||
- Medications costs | • Please tell us about any medications you have been prescribed in the last 6 weeks and who prescribed it | ||
- Cancer related travel costs | |||
- Cancer related food/drink costs | |||
- Additional expenses | |||
• Please tell us about any additional travel costs related to your cancer or cancer treatment you have incurred in the last 6 weeks | |||
EORTC-QLQ C30 [39] | |||
30-item questionnaire with five functional scales (physical, emotional, cognitive, social, role), three symptom scales (fatigue, pain, nausea/vomiting), a global health related quality of life scale, and six single items (anorexia, insomnia, dyspnoea, diarrhoea, constipation, financial difficulties) | Questions are rated on a 4 or 7 point response scales. | • Do you have any trouble taking a long walk | Baseline, 6, 12, 18 weeks and 12 months |
• During the past week… | |||
The scales and single-item responses are recalculated into a score from 0 to 100. | |||
- Have you lacked appetite? | |||
• A high functional scale score represents a high level of functioning | - Were you tired? | ||
- Did you feel depressed? | |||
• A high score for the global health status/QOL represents a high QOL | |||
• A high score for a symptom scale/item represents a high/worse level of symptomatology | |||
Secondary outcomes- Self-efficacy | |||
Self-Efficacy for Managing Chronic Disease [34] | |||
6-Item scale covering several domains common across chronic diseases (symptom control, role function, emotional functioning and communicating with physicians) | Items rated from 1- (not at all confident) to 10 (totally confident) | • How confident are you that you can keep physical discomfort or pain of your disease from interfering with the things you want to do? | Baseline and 18 weeks |
The score for the scale is calculated from the mean of the six items. | • How confident are you that you can do things other than just taking medication to reduce how much you illness affects your everyday life? | ||
Cancer Behaviour Inventory-Brief (CBI-B) [40] | |||
A measure of self-efficacy for coping with cancer. 14 items (adapted from full 33 item measure) | Items are rated on a 9-point scale ranging from 1 (“not all confident”) to 9 (“totally confident”) | Please read each numbered item. Then rate that item on how confident you are that you can accomplish that behaviour. | Baseline and 18 weeks |
- Maintaining independence | |||
- Expressing feelings about cancer | |||
A total score is calculated as the sum of all 12 items. | - Asking physicians’ questions | ||
- Coping with physical changes | |||
Patient Activation Measure (PAM) [41] | |||
13-item scale for measuring the level of patient engagement in their healthcare (knowledge, skill and confidence for self-management) | Statements rated on 4 point scale from disagree strongly to agree strongly and additional N/A option. | • When all is said and done I am the person who is responsible for taking care of my health | Baseline, 18 weeks and 12 months |
• I am confident I follow through on medical treatments I may need to do at home | |||
Responses are combined to provide a single score of between 0 and 100 with higher scores representing higher levels of patient activation. | • I know what treatments are available for my health problems. | ||
Scores can be classified into one of four groups, known as ‘levels of activation’. | |||
Secondary outcomes- eRAPID/IT system performance | |||
System Usability Scale (SUS) [42] | |||
10 item instrument to assess views of usability of an IT systems. | Each statement rated from 1 strongly disagree to 5 strongly agree. | • I think that I would like to use this system frequently | 18 weeks |
• I thought there was too much inconsistency in this system | |||
Responses are calculated into a total score ranging from 0 to 100 with higher scores representing better system usability. | • I felt very confident using the system | ||
eRAPID end of study questionnaire | |||
15 statements/free text boxes to assess participant views of using eRAPID and suggestions for improvements | Statements rated on 3–5 response option scales (e.g. very easy-very difficult) and free text boxes for comments. | • How easy or difficult was it to learn how to use the eRAPID system? | 18 weeks |
• How did you feel about the amount of time it took to complete the symptom questions? | |||
• To what extent do you feel that the symptom questionnaire was useful for the doctors and nurses you saw during your treatment? | |||
• Have you got any suggestions about how the eRAPID system could be improved? |
Data | Description of data | Time point for collection |
---|---|---|
Treatment and clinical information | • Cancer diagnosis, stage and grade | Initial baseline assessment and reviewed for changes at 18 weeks |
• Age, date of birth | ||
• Baseline data on planned chemotherapy | ||
• Changes to treatment delivery and reason | ||
• Comorbidities | ||
Clinical process- Hospital contacts | • Contacts with the hospital e.g. (unplanned) telephone, appointments, consultations | • Data extracted from medical notes for 18 of study |
• Emergency admissions, acute ward stays and reasons for contacts. | ||
• 3 month prior to 12 month follow-up assessment | ||
Clinical process- Information from general practice | • GP recorded problems/concurrent illnesses | • Data extracted from medical notes for 18 week study period |
• Prescribed medications and reasons for prescription (where available) | ||
• 3 month period prior to 12 month follow-up assessment for subset of participants | ||
IT/System functioning | • Researcher maintained log of IT issues (e.g. server downtime, contacts with study participants reporting IT problems or issues logging into eRAPID) and how these were resolved | Throughout trial |
Treatment and clinical information | • Cancer diagnosis, stage and grade | Initial baseline assessment and reviewed for changes at 18 weeks |
• Age, date of birth | ||
• Baseline data on planned chemotherapy | ||
• Changes to treatment delivery and reason | ||
• Comorbidities | ||
Clinical process- Hospital contacts | • Contacts with the hospital e.g. (unplanned) telephone, appointments, consultations | • Data extracted from medical notes for 18 of study |
• Emergency admissions, acute ward stays and reasons for contacts. | • 3 month prior to 12 month follow-up assessment | |
Clinical process- Information from general practice | • GP recorded problems/concurrent illnesses | • Data extracted from medical notes for 18 week study period |
• Prescribed medications and reasons for prescription (where available) | ||
• 3 month period prior to 12 month follow-up assessment for subset of participants | ||
IT/System functioning | • Researcher maintained log of IT issues (e.g. server downtime, contacts with study participants reporting IT problems or issues logging into eRAPID) and how these were resolved | Throughout trial |
Patient outcome measures
Functional assessment in cancer therapy scale-General (FACT-G) [36]
Eq-5D-5 L [38]
Use of resources
EORTC-QLQ-C30 [39]
Self-efficacy and patient activation
Self-Efficacy for Managing Chronic Disease 6-Item Scale [34]
The Cancer Behaviour Inventory- Brief (CBI-B) [40]
The Patient Activation Measure (PAM) [41]
Socio-demographic and clinical process data
-
Number of scheduled and unscheduled hospital contacts (admissions, clinic visits, phone calls with staff)
-
Changes to supportive medications and chemotherapy dose changes
-
Contacts with GP and community services
-
Number of clinician alerts generated from eRAPID severe symptom reports and actions taken by staff
eRAPID system performance
Participant interviews
Staff feedback- interviews and questionnaires
-
Clinician reports of use of eRAPID patient data during consultations
-
At 6 weeks routine clinic visits clinicians are asked to complete CTCAE scoring form matching those AE completed by patients on the eRAPID questionnaire