Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress
Stopped: Study team is not moving forward with protocol
0Started 2023-10-31
Plain-language summary
The present study will investigate if ketamine-assisted psychotherapy during palliative radiation therapy is safe, feasible, and effective at reducing psychological distress.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject have provided informed consent
* Male or female ≥ 21 to ≤ 65years of age at signing of informed consent
* Moderate-severe anxiety or depression related to cancer as measured by the GRID-HAM-D17 (depression) or the HAM-A (anxiety)
* Prescribed a radiation therapy course with palliative intent. Radiation therapy will be given priority with respect to scheduling and delivery over appointments related to KAP. Patients may begin the KAP process as soon as they are able after enrollment as long as it does not interfere with or delay receipt of radiation therapy. The timing of KAP/ RT can be either concurrent or sequential with RT coming first based on convenience to the patient and treatment teams, although completing the treatment expediently will be encouraged. Total treatment package time should be less than 3 months from CT simulation.
* A female subject of childbearing potential who is sexually active with a non-sterilized male partner must agree to consistently and correctly use a highly effective method of contraception with a failure rate of \< 1% per year (Appendix 1) during the study and for at least 90 days after study drug administration. If a hormonal contraceptive is used, it must have been initiated at least 1 month before dosing.
* Negative pregnancy test (women only)
* Female subject of non-childbearing potential must be either: surgically sterile (hysterectomy, tubal ligation, or bilateral oophorectomy), or post-menopausal with ameno…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of population completing at least one KAP session.
Timeframe: Within 6 months from completion of radiation therapy