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CompletedNCT01074385Updated Sep 16, 2013

Dignity Therapy in mCRC to Increase Peaceful Awareness & Impact Goals of Care Decision-Making

An interventional study of Dignity Therapy in Stage IV Colorectal Cancer, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-16.

Sponsored by Northwestern University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to try and improve the way that patients with colon cancer understand and cope with their illness and give them tools for talking with their loved ones and family about their illness.

Read the detailed description

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.

02

Conditions studied

  • Stage IV Colorectal Cancer

Keywords

  • Stage IV Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's enrollment of 24 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Other
    Immediate Dignity Therapy

    At registration, subjects will be mailed a questionnaire. The subject will then receive two separate dignity therapy sessions, about a week apart. Subjects will then be asked to complete a questionnaire 1-2 weeks after completing therapy sessions and one month after completing therapy sessions.

    Behavioral: Dignity Therapy

  • Other
    Wait List Dignity Therapy

    At registration, subjects will be mailed a questionnaire. The subject will then receive two separate dignity therapy sessions; the first session will take place about 6 weeks after registration, with the second session occurring 1-3 weeks after the first. Subjects will then be asked to complete a questionnaire about one month after completing therapy sessions.

    Behavioral: Dignity Therapy

Interventions

  • BehavioralDignity Therapy

    Dignity therapy is a psychotherapeutic intervention developed to address psychosocial and existential distress among terminally ill patients. Basically, it invites patients to discuss topics that matter most or how they want to be remembered. This interview is recorded and then edited and returned to the patient to be used for further reflection or for sharing with loved ones.

06

What researchers measure

Primary outcomes

  1. Impact of Dignity Therapy

    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.

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

Secondary outcomes

  1. Measure the impact of dignity therapy on life sustaining therapy and end-of-life goals of care.

    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.

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

  2. Establish a correlation between terminal illness acknowledgement and presence of peaceful awareness with preferences for life sustaining therapy and end-of-life goals of care.

    Establish a correlation between terminal illness acknowledgement and presence of peaceful awareness with preferences for life sustaining therapy and end-of-life goals of care.

    Time frame: At Study Completion

07

Study locations

1 site
  • Northwestern University, Northwestern Memorial Faculty Foundation
    Chicago, Illinois 60611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01074385
Lead sponsor
Northwestern University
Collaborators
Robert H. Lurie Cancer Center
Responsible party
Sponsor
First posted
Feb 24, 2010
Start date
Apr 2010
Primary completion
May 2012
Completion
Oct 2012
Last update
Sep 16, 2013

Study contacts

Linda Emanuel, MD, PhD
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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