Supporting a loved one in deciding whether to join a Phase 3 clinical trial for chronic kidney disease (CKD) can be challenging. Here are some key tips for caregivers:
1. Gather Information
- Understand the Trial: Read the trial protocol, including its purpose, eligibility criteria, treatment details, and potential risks/benefits.
- Ask About Alternatives: Learn about standard treatments available outside of the trial.
- Check the Logistics: Find out how often your loved one will need to visit the trial site and what’s required in terms of tests, medications, and follow-ups.
2. Discuss Risks & Benefits
Potential Benefits: Access to a potential new treatment, closer medical monitoring, and contributing to medical advancements.
Possible Risks: Side effects, placebo group assignment, and uncertainty of results.
3. Prepare Questions for the Study Team
Encourage your loved one to ask:
- How does this treatment compare to existing options?
- What are the common and rare side effects?
- What costs are covered (medications, travel, doctor visits)?
- Can they leave the trial if needed?
4. Consider Their Personal Goals & Quality of Life
- Does the trial align with their values and long-term health goals?
- Will participation improve or maintain their quality of life?
- How might it impact daily routines, work, or other responsibilities?
5. Seek Input from Trusted Sources
- Consult their nephrologist or primary care doctor for an objective opinion.
- Discuss with patient advocacy groups like the National Kidney Foundation.
- Connect with other patients who have participated in trials.
6. Address Emotional & Psychological Aspects
- Be empathetic and acknowledge their fears or hesitations.
- Encourage them to take their time—there’s no rush unless eligibility is time-sensitive.
- Remind them that they have the right to withdraw at any time.
7. Review the Informed Consent Document Carefully
- Make sure they understand all aspects before signing.
- If needed, ask for a plain-language summary.
- Verify who to contact for concerns or side effects.
8. Assist with Practical Needs
- Help with appointment scheduling and transportation.
- Offer to organize paperwork or track symptoms and side effects.
- Be a second set of ears during medical visits.
9. Support Their Final Decision
- Respect their choice, whether they join or not.
- Reassure them that they are making the best decision with the information available.
