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Use of Dignity Therapy in Stage IV Colorectal Cancer Patients Receiving Chemotherapy to Increase Peaceful Awareness and Impact Goals of Care Decision-Making


N/A
18 Years
N/A
Open (Enrolling)
Both
Stage IV Colorectal Cancer, Dignity Therapy

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Trial Information

Use of Dignity Therapy in Stage IV Colorectal Cancer Patients Receiving Chemotherapy to Increase Peaceful Awareness and Impact Goals of Care Decision-Making


Dignity Therapy is a well tolerated structured interview that helps patients reflect on who
they are, what is most important to them and what lessons they have learned through life.
For patients not receiving chemotherapy, Dignity Therapy gave patients more hope, more
meaning in their life, and helped their families. Researchers at Northwestern University
would like to see if it has the same effect in patients getting chemotherapy. We will also
see if the Dignity Therapy changes patient's understanding of their disease and their
medical preferences.

All study procedures will take place when participants come for a scheduled doctor's visit
or to receive chemotherapy. At the first visit participants will answer a questionnaire
taking approximately 15-30 minutes. Participants will then have a Dignity Therapy Session
approximately 1-2 weeks later. A second Dignity Therapy Session will be scheduled again in
another 1-2 weeks. Each study Dignity Therapy Session will take approximately an hour. One
to two weeks later a repeat questionnaire will be filled out. Finally, a third and final
questionnaire will be complete 4 weeks later.


Inclusion Criteria:



- Participants must be currently receiving treatment for stage IV colorectal cancer.

- Participants must have experience disease progression after their first course of
treatment and are being considered for second course of treatment or have already
started their second course of treatment.

- Participants must be 18 years old or older.

- All participants must have given signed, informed consent prior to registration on
study.

- Participants must speak English.

Exclusion Criteria:

-

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Impact of Dignity Therapy

Outcome Description:

Measure the impact of dignity therapy on terminal illness acknowledgment and presence of peaceful awareness. Subjects will complete self-evaluation questionnaires at the point of registration and upon completing dignity therapy sessions. The impact will be determined by changes in the patient's baseline self-reported parameters.

Outcome Time Frame:

at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of sessions

Safety Issue:

No

Principal Investigator

Max Vergo, MD

Investigator Role:

Study Director

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

NU 09CC3

NCT ID:

NCT01074385

Start Date:

April 2010

Completion Date:

April 2015

Related Keywords:

  • Stage IV Colorectal Cancer
  • Dignity Therapy
  • Stage IV Colorectal Cancer
  • Dignity Therapy
  • Colorectal Neoplasms

Name

Location

Northwestern University, Northwestern Memorial Faculty Foundation Chicago, Illinois  60611