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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00737399
Other study ID # SMI-CHOL-82008
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date September 2008
Est. completion date December 2028

Study information

Verified date April 2024
Source Soul Medicine Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Anxiety and depression have been found to be significant co-occurring conditions in cancer patients. This study examines these and other psychological conditions in patients diagnosed with cholangiocarcinoma, a rare cancer of the bile duct, with an average survival time of three to six months post-diagnosis. Participants are taught EFT in telephone and internet group coaching sessions, and have access to an online support forum. They complete the Mini-Mental Adjustment to Cancer Scale (Mini-MAC), EORTC Quality of Life scale, the PTSD checklist, the Patient Health Questionnaire, and a brief health checklist. Participants also provide medical records confirming their diagnosis, and markers, both before and after the study. The study is expected to enroll 20-15 cholangiocarcinoma patients, and use a within-subjects, time series, repeated measures design. Symptoms are assessed prior to coaching, after four, and again after eight weekly coaching sessions. Follow-ups will occur in one month, three months, and one year. It is hypothesized that a drop in the severity of co-occurring psychological symptoms, pain and insomnia may occur after EFT coaching.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 14
Est. completion date December 2028
Est. primary completion date April 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - Diagnosis of cholangiocarcinoma - Ability to complete forms and attend phone coaching sessions Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Lifestyle Counseling with Emotional Freedom Techniques (EFT)
Two series of four sessions of phone support group coaching instruction in the use of EFT

Locations

Country Name City State
United States Soul Medicine Institute Santa Rosa California

Sponsors (1)

Lead Sponsor Collaborator
Soul Medicine Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Endo I, Gonen M, Yopp AC, Dalal KM, Zhou Q, Klimstra D, D'Angelica M, DeMatteo RP, Fong Y, Schwartz L, Kemeny N, O'Reilly E, Abou-Alfa GK, Shimada H, Blumgart LH, Jarnagin WR. Intrahepatic cholangiocarcinoma: rising frequency, improved survival, and determinants of outcome after resection. Ann Surg. 2008 Jul;248(1):84-96. doi: 10.1097/SLA.0b013e318176c4d3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary depression duration of study
Secondary anxiety duration of study
Secondary pain duration of study
Secondary insomnia duration of study
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