Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Caregivers of Patients With Advanced Cancer

Summary

The PEARL-C1 trial is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy.

Timeline

Start

2025-07-16

Primary completion

2027-12-02

Completion

2027-12-02

Publications

• Background Braun M, Mikulincer M, Rydall A, Walsh A, Rodin G. Hidden morbidity in cancer: spouse caregivers. J Clin Oncol. 2007 Oct 20;25(30):4829-34. doi: 10.1200/JCO.2006.10.0909.
• Background Burton LC, Newsom JT, Schulz R, Hirsch CH, German PS. Preventive health behaviors among spousal caregivers. Prev Med. 1997 Mar-Apr;26(2):162-9. doi: 10.1006/pmed.1996.0129.
• Background Glajchen M. The emerging role and needs of family caregivers in cancer care. J Support Oncol. 2004 Mar-Apr;2(2):145-55.
• Background Grunfeld E, Coyle D, Whelan T, Clinch J, Reyno L, Earle CC, Willan A, Viola R, Coristine M, Janz T, Glossop R. Family caregiver burden: results of a longitudinal study of breast cancer patients and their principal caregivers. CMAJ. 2004 Jun 8;170(12):1795-801. doi: 10.1503/cmaj.1031205.
• Background Hales S, Chiu A, Husain A, Braun M, Rydall A, Gagliese L, Zimmermann C, Rodin G. The quality of dying and death in cancer and its relationship to palliative care and place of death. J Pain Symptom Manage. 2014 Nov;48(5):839-51. doi: 10.1016/j.jpainsymman.2013.12.240. Epub 2014 Apr 3.
• Background Holm M, Alvariza A, Furst CJ, Ohlen J, Arestedt K. Psychometric evaluation of the anticipatory grief scale in a sample of family caregivers in the context of palliative care. Health Qual Life Outcomes. 2019 Mar 5;17(1):42. doi: 10.1186/s12955-019-1110-4.
• Background Johansson AK, Grimby A. Anticipatory grief among close relatives of patients in hospice and palliative wards. Am J Hosp Palliat Care. 2012 Mar;29(2):134-8. doi: 10.1177/1049909111409021. Epub 2011 May 19.
• Background Kershaw T, Ellis KR, Yoon H, Schafenacker A, Katapodi M, Northouse L. The Interdependence of Advanced Cancer Patients' and Their Family Caregivers' Mental Health, Physical Health, and Self-Efficacy over Time. Ann Behav Med. 2015 Dec;49(6):901-11. doi: 10.1007/s12160-015-9743-y.
• Background Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Background Nissim RS, Hales S. Caring for the Family Caregiver: Development of a Caregiver Clinic at a Cancer Hospital as Standard of Care. J Clin Psychol Med Settings. 2023 Mar;30(1):111-118. doi: 10.1007/s10880-022-09891-8. Epub 2022 Jun 14.
• Background Nissim, R., Hales, S., Zimmermann, C., Deckert, A., Edwards, B., & Rodin, G. (2017). Supporting Family Caregivers of Advanced Cancer Patients: A Focus Group Study. Family Relations, 66(5), 867-879
• Background Pendergrass A, Malnis C, Graf U, Engel S, Graessel E. Screening for caregivers at risk: Extended validation of the short version of the Burden Scale for Family Caregivers (BSFC-s) with a valid classification system for caregivers caring for an older person at home. BMC Health Serv Res. 2018 Apr 2;18(1):229. doi: 10.1186/s12913-018-3047-4.
• Background Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D. Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy--Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med. 2002 Winter;24(1):49-58. doi: 10.1207/S15324796ABM2401_06.
• Background Pitceathly C, Maguire P. The psychological impact of cancer on patients' partners and other key relatives: a review. Eur J Cancer. 2003 Jul;39(11):1517-24. doi: 10.1016/s0959-8049(03)00309-5.
• Background Reinhard SC, Given B, Petlick NH, Bemis A. Supporting Family Caregivers in Providing Care. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 14. Available from http://www.ncbi.nlm.nih.gov/books/NBK2665/
• Background Rosa WE, Sager Z, Miller M, Bernstein I, Doerner Rinaldi A, Addicott K, Ljuslin M, Adrian C, Back AL, Beachy J, Bossis AP, Breitbart WS, Cosimano MP, Fischer SM, Guss J, Knighton E, Phelps J, Richards BD, Richards WA, Tulsky JA, Williams MT, Beaussant Y. Top Ten Tips Palliative Care Clinicians Should Know About Psychedelic-Assisted Therapy in the Context of Serious Illness. J Palliat Med. 2022 Aug;25(8):1273-1281. doi: 10.1089/jpm.2022.0036. Epub 2022 Mar 14.
• Background Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Background Steinhauser KE, Voils CI, Bosworth HB, Tulsky JA. Validation of a measure of family experience of patients with serious illness: the QUAL-E (Fam). J Pain Symptom Manage. 2014 Dec;48(6):1168-81. doi: 10.1016/j.jpainsymman.2014.04.006. Epub 2014 May 22.
• Background Theut SK, Jordan L, Ross LA, Deutsch SI. Caregiver's anticipatory grief in dementia: a pilot study. Int J Aging Hum Dev. 1991;33(2):113-8. doi: 10.2190/4KYG-J2E1-5KEM-LEBA.

Drugs

Indications

No indication recorded.