NCT00737399

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at P25-P50 for early_phase_1 depression

Timeline
32mo left

Started Sep 2008

Longer than P75 for early_phase_1 depression

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Sep 2008Dec 2028

First Submitted

Initial submission to the registry

August 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

September 20, 2008

Completed
19.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2028

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

19.6 years

First QC Date

August 18, 2008

Last Update Submit

April 22, 2026

Conditions

Keywords

depressionanxietypaininsomniacancercholangiocarcinomaEFT (Emotional Freedom Techniques)

Outcome Measures

Primary Outcomes (1)

  • depression

    duration of study

Secondary Outcomes (3)

  • anxiety

    duration of study

  • pain

    duration of study

  • insomnia

    duration of study

Study Arms (1)

1

EXPERIMENTAL

Lifestyle Counseling with Emotional Freedom Techniques (EFT)

Behavioral: Lifestyle Counseling with Emotional Freedom Techniques (EFT)

Interventions

Two series of four sessions of phone support group coaching instruction in the use of EFT

1

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of cholangiocarcinoma
  • Ability to complete forms and attend phone coaching sessions

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soul Medicine Institute

Santa Rosa, California, 95403, United States

Location

Related 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.

    PMID: 18580211BACKGROUND

Related Links

MeSH Terms

Conditions

DepressionAnxiety DisordersPainSleep Initiation and Maintenance DisordersNeoplasmsCholangiocarcinoma

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Dawson Church, PhD

    Soul Medicine Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 19, 2008

Study Start

September 20, 2008

Primary Completion (Estimated)

April 23, 2028

Study Completion (Estimated)

December 25, 2028

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations