SOFTLI
Research type
Research Study
Full title
Improving Care through Soft Robotic Tactile Intervention - Towards a smarter compassionate experience in cancer treatment
IRAS ID
266016
Contact name
Helen McNair
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Duration of Study in the UK
0 years, 10 months, 9 days
Research summary
Summary of Research
Patients often undergo procedures and treatments, as part of their care, where they are unaccompanied e.g. MRI scans or radiotherapy treatments. This can sometimes create anxiety or a feeling of isolation. We aim to investigate if we can create an aide which can help alleviate stress and anxiety by simulating touch, to give comfort to the patient. This may avoid cancelling of procedures or using invasive methods, e.g. anesthesia. The study will be in 3 stages.
Stage 1: We will conduct 3 separate focus groups with caregivers of patients, patients who have received radiotherapy treatment for their cancer in the past and healthcare professionals. They will be facilitated to describe where in their radiotherapy cancer pathway they experienced or were most likely to experience anxiety. Some prototypes of the aide will be presented and they will be asked for feedback on design and usability. They will also be invited to suggest what the device should look like, feel like and where and how it would be best used.
Stage 2 will involve developing the prototype and ensuring it is safe, can be used in treatment and MR rooms and ensuring it meets cross infection and medical device requirements.
Stage 3 will involve patients and healthy volunteers who will be asked to test the device. They will be asked via a questionnaire to feedback on acceptability.Summary of Results
Anxiety is present throughout radiography procedures for cancer care, both therapeutic and diagnostic, and there are limitations in methods available to alleviate this, due to time, safety and contraindications. A wearable haptic technology device to simulate touch and human presence was created using co-design with patients, carers and health professionals. Seven focus groups with 34 participants were undertaken. A prototype device was created and tested on six patients currently receiving radiotherapy for cancer. The device was safe and cleanable. Five of the six patients tested were overwhelmingly positive about the warmth, feel and appearance of the device. The next step is to refine aspects of the device to make it easily accessible to patients.
Background: Anxiety and psychological stress of the patient and their families during cancer treatment occurs to up to 49% of the patient population1,2. Existing interventions are either remotely administered, e.g. verbal communication or music which do not overcome the lack of physical presence and support or include the use of costly invasive sedation methods. Improving Care through Soft Robotic Tactile Intervention (SOFTLI) was a collaboration between Royal College of Art (Caroline Yan Zheng, Research associate & PhD Candidate), Imperial College (Prof. Alison McGregor, Professor of Musculoskeletal Biodynamics, Faculty of Medicine, Department of Surgery & Cancer), and Royal Marsden NHS Foundation Trust and Institute of Cancer Research (Dr. Helen McNair, HEE/NIHR Senior clinical lecturer, Lead research radiographer and Reader) and funded by CRUK ICR–Imperial Convergence Science Centre Development Fund.
This report will present the results of the SOFTLI study which took place in between November 2019 and February 2021 before describing next steps.
Objectives:
• To identify the most impactful combination of parameters to form a design brief for a soft robotic tactile intervention (SRTI) to meet the patients’ needs.
• To prototype and manufacture, the initial test SRTI via an iterative process based on user and patient need.
• To investigate the feasibility and acceptability of using the SRTI.Methods: A mixed methods study was designed to extract views of two stakeholder groups: Patients and/or Caregivers and radiographers. The study was approved by Greater Manchester South Research Ethics Committee and the Health and Care Research Wales. Patients and/or caregivers were recruited via information flyers positioned in the radiotherapy waiting rooms and an internal email was sent to radiographers. A participant information sheets was used to follow up interest, consent obtained and anonymity ensured.
A total of seven focus groups with 34 participants were undertaken, recorded, transcribed verbatim and independently coded by the research teams.Objective 1: Six focus groups, four patient and caregiver groups and two radiographer groups, firstly explored where anxiety and stress were present during the cancer diagnosis and treatment pathway. Secondly, participants were invited to try example devices and feedback on the different forms, patterns of sensation and interaction (both control methods and body location). Key points identified by all groups were warmth, patient control, ability to be located on multiple locations on body and visually interesting (Table 1). Other aspects considered were where it would be available for example waiting room or treatment room and infection control.
Objective 2: The device was created, and radiographer participants were invited back to test the device for the seventh focus group. Radiographers fed back on aspects of infection control and cleanliness, robustness, control and ease of use. Overall, there was positive feedback especially regarding the warmth and sensations of the device.
Patients were unable to view the device because of COVID restrictions but were contacted via email and asked about design and colour preferences. Bright colours and patterns were highly favoured. There was a strong request for the device not to look clinical. A digital platform displaying the final design choices was utilised and all participants were asked to pick a preferred design and leave their reasoning in a comments box. Most participants engaged in this platform and were able to express their views promptly and easily.
Objective 3: The final proof of concept prototype was created and consisted of an ‘armband’(Figure 1), a control box, patient control and staff control. The armband is completely soft and made from skin-safe silicone material. Neither the armband nor the patient control has any metal nor electromagnetic parts. The armband can be set at desirable temperature by circulating warm water through the outer layer. Air is compressed into the skin-contacting layer to produce the desirable tactile stimulations. The wristband and the control box are connected through tubing. The control box enclosing the pneumatic and hydraulic control system was stored at 4 meters distance from the treatment bed. A staff control button board was threaded through the ‘rat run’ to be placed on the staff control table. Patient can control ‘on’ and ‘off’ of one pattern of touch stimulation (‘stroking’) using their thumb. Staff can control ‘on’, ‘off’ and choose between two patterns of touch stimulation (‘stroking’ and ‘holding’).
The feasibility of using the device whilst patients were receiving radiotherapy was tested and feedback gained via a questionnaire. Six patients, undergoing radiotherapy and who had not previously been involved in the study, consented. After treatment the patient was setup in the radiotherapy treatment position, the device attached to their wrist and the control was held by the other hand (Figure 2). The staff control was placed at the staff control table. The device was tested with patient and radiographer control over a ten-minute period. Patients were then asked to complete a questionnaire (Figure 3). All patients that tested the device were able to feel the remote touching and felt the motions repeatability. Patients expressed it had therapeutic value, not unpleasant and they could not tell the difference between the stroking of a human hand and the device. There were minimal negative comments about the device and only one patient found the device irritating. Affective touch is also a type of social touch. The emotions elicited also depend on personal individual touch preference, cultural background and mental health status. For example, there are existing studies on social anxiousness contributing to aversion toward affective touch and supportive social touch 3,4. Future work can include social touch preference assessment tools4 to gain more information on patient preference.
This study look place when social distancing and essential travel were enforced and so there were set-backs due to reduced patients and/or caregivers and staff. It is also worth noting the success of the digital platform in reaching out to participants and asking them to still engage when face-to-face engagement was not possible. Improving Care through Soft Robotic Tactile Intervention (SOFTLI) | Cancer Patients' Voice (cancerbrc.org)
Conclusion: We have developed and successfully tested the feasibility of a wearable haptic technology device to simulate touch and human presence. Patients and staff were positive about the look and feel of the device .
The SOFTLI device is applicable to many health care settings where patients experience isolation, for example COVID patients, or loneliness for example attending appointments alone or waiting in waiting room/consulting room for results.
We envisage the next step to seek funding and collaboration to refine the device to make it easily accessible to patients. This device is applicable to patients in many situations, not only radiotherapy and imaging departments. Refinements would include a smaller pump with more robust connections. A portable device could be explored because it would be used in any department for example waiting rooms, when having chemotherapy, or if isolated because of other medical reasons for example COVID patients. We would require experience in design for a patient facing device with appropriate regulations.
References
1. Elsner K, Naehrig D, Halkett GKB, Dhillon HM. Reduced patient anxiety as a result of radiation therapist-led psychosocial support: a systematic review. J Med Radiat Sci. 2017;64(3):220-31.
2. Holmes N, Williamson K. A survey of cancer patients undergoing a radical course of radiotherapy, to establish levels of anxiety and depression. J Radiother Pract. 2008;7(2):89-98.
3. Kashdan, T. B., Doorley, J., Stiksma, M. C., & Hertenstein, M. J. (2017). Discomfort and avoidance of touch: New insights on the emotional deficits of social anxiety. Cognition and Emotion, 31(8), 1638–1646. https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbV-2FULWZYNfoTIKQPET8QtGaQ9b4-2Fb1SWPDW18-2BoSyagpmBJhvbTNOGj13giZ6Oneyg-3D-3Dzirs_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLukW-2FT2o21Bc5jnUI6CgqYvwDDo5Q-2Fc720MtnAtqKZp6z726ghWKDwi-2BNXf7WeaGrVaGwEvxITHPYeL0Tvg-2Fp2gYFH89GcNXNwdUssDOT3DcAxEIcku3Cw-2Fo5K7jbaleSeeCvlCV0WpvVMBFBCvJpi1nn2PfzN-2FhKDcu4Ffa5hbDj-2BO-2BA-2BAYt2a82oQCMjMzg-3D&data=05%7C01%7Cgmsouth.rec%40hra.nhs.uk%7Cc36f38b7349e410518cf08dba92a111a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638289770368621474%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=MQeXiosJc%2BgAxRNn6wWXb4C2q4aNEtH80NiEpkRdJIA%3D&reserved=0
4. Wilhelm, F. H., Kochar, A. S., Roth, W. T., & Gross, J. J. (2001). Social anxiety and response to touch: Incongruence between self-evaluative and physiological reactions. Biological Psychology, 58(3), 181–202. https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbaNKhM2veQCpNbb8U3lc6HQLkF4cMsSzy-2BUPkbPfMvWCikXmKexHiQ7Zq0O-2BoPgdlA-3D-3DwvS2_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLukW-2FT2o21Bc5jnUI6CgqYwSZKIJ8e-2FhMrSi4CefzP4IAxOFEchm2KKC4WYjkkiIf7hm3HYssRQzD0fEjCfiTOBePzdeOkrwiMINpO9GNsK-2B9rrtpJ984JO761dVGeQ4D25LdZJERS-2BbD8om-2B9aABK03FK8viCY2m5CWfFTiHwSSnk-2Fu1eoGsCO1yQrfBifzQ-3D&data=05%7C01%7Cgmsouth.rec%40hra.nhs.uk%7Cc36f38b7349e410518cf08dba92a111a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638289770368621474%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Z6TooOyE1OO82M3UJUbkRSs2O8Bcd2L1qPr1HL0rI2A%3D&reserved=0REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0607
Date of REC Opinion
25 Sep 2019
REC opinion
Favourable Opinion