Clinical trials: essentials for caregivers

FESCA•Clinical trials and scleroderma•Clinical trials: essentials for caregivers

Whether you’re a partner, sibling, child or friend of someone living with scleroderma, evidence shows that your support really does make a difference.

If their doctor is talking to them about taking part in a clinical trial as part of their care, here are answers to common questions.

If you’re a parent of a child living with scleroderma, you can find information here

Should I encourage someone I care for to take part in a trial?

Deciding whether to take part in a clinical trial is a big decision for someone living with scleroderma.

Trials are carefully designed research studies that test new scleroderma treatments, ways of using existing treatments or approaches to care.

However, clinical trials can also involve uncertainty, possible side effects and extra appointments and tests.

What matters most for them is:

  • They need to make the decision
  • They need good information – so they clearly understand the purpose, risks and benefits of the trial before agreeing to take part
  • Open conversations – so they can talk about their hopes, worries and expectations

What matters most for you as a caregiver is:

  • If you need to come to the visits, would you be able to take this time out of your life and work?
  • Would you get compensation for taking the time off work?

You can help by:

  • Understanding the type of scleroderma they have
  • Reading the patient information sheet about the trial together
  • Writing down questions for the research team
  • Encouraging them to take their time before making a decision

How do I know they will be safe if they join a trial?

You might find it reassuring to know that safety is the top priority during all scleroderma trials.

If the person you’re supporting decides to get involved:

  • Their eligibility will be checked carefully before they join
  • Their health will be monitored closely throughout the trial
  • They will be given contact details so they can get help straight away if they notice any side effects or have any questions or concerns
To help you understand how their safety will be managed day-to-day, you might like to ask the research team:
  • How will their information be shared with their current doctors?
  • Who can we contact if something changes?
  • How often will health checks happen?
  • What additional support is available – such as wellbeing resources or support groups?

What is expected of me as a caregiver?

Your involvement will vary depending on the trial, your situation and your relationship with the person living with scleroderma.

You will not be expected to take on a medical role, but you can help with practical and emotional support. Some trials may also have questionnaires or other tasks for caregivers.

Your support can include:

  • Helping to make sure appointments are written down on the calendar or in a diary
  • Driving your loved one to and from appointments
  • Picking up prescriptions and medication
  • Supporting medication routines – for example, setting up a phone reminder
  • Taking notes during appointments
  • Keeping notes in between appointments – for example, changes in symptoms or questions you want to ask at the next appointment
  • Providing encouragement during ups and downs

It’s also okay to set boundaries. You are a caregiver, not a healthcare professional, and your wellbeing matters too.

Will I have access to support and mental wellbeing resources?

Caregiving for someone with a lifelong health condition like scleroderma can feel overwhelming at times - especially if they’re involved in a clinical trial,. Looking after yourself is crucial.

If you are supporting someone involved in a clinical trial, you may want to ask the research or healthcare team:
  • What support is available for caregivers or family members – are there charities, support groups or counselling services?
  • Are there support groups or networks for people for people caregiving for someone taking part in a trial for scleroderma?
  • Who can I contact if I feel overwhelmed or need support?

Reaching out for support early – before feelings of stress, exhaustion or anxiety build up – can make a big difference.

Getting the right support at the right time can help you look after your own health while continuing to care for someone else.

How do I share concerns without nagging?

It can be difficult to mention any concerns you have, especially if you don’t want to worry or frustrate the person you’re caring for.

  • Try to remember that living with scleroderma is an ongoing learning process, both for someone with a diagnosis as well as for you as the caregiver
  • Use “I” statements
    Instead of“You look really tired”
    Try“I’ve noticed you seem more tired lately – how are you feeling?”
  • Choose a calm, private moment to mention your concerns
  • Be specific but gentle about what you’ve noticed
  • Encourage them to tell the research team about any worries you have

If you’re unsure, you can also contact the research team directly to tell them about any changes you’ve noticed.

Will I be paid for any time off work or expenses?

Some research studies provide financial support for participants and sometimes for their caregivers.

This can include:

  • Travel and/or parking costs
  • Meals during hospital visits
  • Payment for time
  • Certain expenses

The budget varies from trial to trial It is unlikely that all costs and lost income will be covered.

At the start of the trial, you might want to ask:
  • Which expenses are paid?
  • Is there any payment available to cover caregiver time when they’re supporting someone at appointments?
  • How do we claim our expenses?

Gathering all the information before you know how much support you can offer helps both you and the person you’re supporting to plan practically and financially.

What should I do if I’m worried the trial isn’t going well?

Trust your instincts. If something feels wrong, it’s always okay to speak up.

You can:

  • Encourage the person you’re caregiving for to contact the trial team or their doctor
  • Contact the research team yourself – ideally with the patient’s permission, but without their permission if you’re worried
  • Ask the trial research team for a review or for an extra appointment if you have any questions about symptoms or side effects

Remember:

  • Participants can leave a scleroderma trial at any timewithout explanation and without the decision affecting their usual care
  • Asking questions will not “cause trouble” – it will help to keep the person you’re caring for safe
Sources (20)
  1. Journal of Scleroderma and Related Disorders. Factors associated with life satisfaction in systemic sclerosis: examining the moderating roles of social support and spiritual well-being. https://pmc.ncbi.nlm.nih.gov/articles/PMC10202482/“Participants with […] less social support […] report worse life satisfaction.”
  2. Clinical Research and Clinical Trials: An In-Depth Exploration. https://www.jclinical.org/full-text/clinical-research-and-clinical-trials-an-in-depth-exploration“Clinical research and clinical trials are fundamental to developing new medical interventions, ensuring treatments are safe and effective before reaching the market.”
  3. National Cancer Institute (NCI). Participate in cancer treatment trials. https://www.cancer.gov/research/participate/how/treatment-trials“The study treatment may not be better than, or even as good as, the standard treatment.”
  4. National Institute on Aging (NIA). Clinical research: benefits, risks, and safety. https://www.nia.nih.gov/health/clinical-trials-and-studies/clinical-research-benefits-risks-and-safety“For those who receive the experimental treatment, it may be uncomfortable or cause side effects (which can range from mild to serious).”
  5. National Heart, Lung, and Blood Institute (NHLBI). Clinical trials: benefits, risks, and safety measures. https://www.nhlbi.nih.gov/research/clinical-trials/safety-benefits-risks“The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more procedures, hospital stays, or complex dosage schedules.”
  6. Nclusiv. Patient information sheets for research studies: compliance guide. https://nclusiv.co.uk/blog/f/patient-information-sheets-for-research-studies-compliance-guide“The Health Research Authority (HRA) in the UK provides specific guidance on content requirements, including: The purpose of the research and why the participant has been invited; What participation will involve in terms of procedures, duration, and expectations; Potential benefits and risks of participation.”
  7. ICH Guideline for Good Clinical Practice – Monitoring: ICH GCP. https://ichgcp.net/monitoring“The purposes of trial monitoring are to verify that: (a) The rights and well-being of human subjects are protected.”
  8. Eligibility Criteria: National Institutes of Health (NIH). https://clinicalinfo.hiv.gov/en/glossary/eligibility-criteria“Factors used to determine whether a person is eligible (inclusion criteria) or not eligible (exclusion criteria) to participate in a clinical trial.”
  9. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Monitoring of clinical trials. https://ichgcp.net/monitoring“Monitoring is carried out to ensure that the rights and well-being of participants are protected and that trials are conducted safely and correctly.”
  10. Nclusiv. Patient information sheets for research studies: compliance guide. https://nclusiv.co.uk/blog/f/patient-information-sheets-for-research-studies-compliance-guide“The Health Research Authority (HRA) in the UK provides specific guidance on content requirements, including […] contact information.”
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  13. European Psychiatry. https://pmc.ncbi.nlm.nih.gov/articles/PMC12438400/“The BREF programme demonstrated significant benefits, notably reducing caregivers’ depressive symptoms and burden. Designed for early systematic implementation this standardized, time- and resource- efficient intervention, offers à promising foundation for a structured and graduated support pathway for caregivers.”
  14. BMJ Quality and Safety. Speaking up about care concerns in the ICU: patient and family experiences, attitudes and perceived barriers. https://qualitysafety.bmj.com/content/27/11/928“Speaking up may be challenging for ICU patients/families.”
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  16. Baer AR, Good M, Schapira L. A new look at informed consent for cancer clinical trials. J Oncol Pract. 2011;7(4):267–270. https://pmc.ncbi.nlm.nih.gov/articles/PMC3140452/“Prospective participants need to be adequately informed and given the opportunity to ask questions and consult with relatives or friends without feeling pressured or rushed.”
  17. European Patients’ Academy on Therapeutic Innovation. Compensation in clinical trials https://toolbox.eupati.eu/resources/compensation-in-clinical-trials/“Although not always a standard, in many clinical trials participants receive some form of compensation for their participation. This may take the form of money, or the reimbursement of […] food or food vouchers, or other services.”
  18. Pfizer. https://www.pfizer.com/science/clinical-trials/integrity-and-transparency/payment-reimbursement-participants“In addition, Pfizer may offer reasonable payment to parents, guardians, or caregivers of minor children or incapacitated study participants.”
  19. European Patients' Academy on Therapeutic Innovation (EUPATI). Compensation and reimbursement to trial participants. https://learning.eupati.eu/mod/book/view.php?id=347&chapterid=306“Compensation for Participation: It depends on the sponsor and the given study whether or not compensation is paid to participants. […] According to one report by the European Forum for Good Clinical Practice (EFGCP) (2), legislation and practice in Europe vary widely from country to country.”
  20. Oxford University Hospitals NHS Foundation Trust. Consent https://www.ouh.nhs.uk/researchers/conduct/consent/“Participants must be told that they are ‘free to withdraw from the trial at any time for any reason without prejudice to future care’.”