Stage IV Colorectal CancerNCT01074385
Dignity Therapy in mCRC to Increase Peaceful Awareness & Impact Goals of Care Decision-Making
A study testing Dignity Therapy in people with Stage IV Colorectal Cancer, run by Northwestern University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Colorectal Cancer
- What is being tested?
- Dignity Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University, Northwestern Memorial Faculty Foundation
Chicago, Illinois, 60611
About this study
Official title: Use of Dignity Therapy in Stage IV Colorectal Cancer Patients Receiving Chemotherapy to Increase Peaceful Awareness and Impact Goals of Care Decision-Making
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.
- Conditions
- Stage IV Colorectal Cancer
- Being tested
- Dignity Therapy
- Keywords
- Stage IV Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dignity TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Dignity Therapy | Other | 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. Receives: Behavioral: Dignity Therapy |
| Wait List Dignity Therapy | Other | 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. Receives: Behavioral: Dignity Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of sessions
Secondary outcomes (2)
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.
Measured: at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of dignity therapy sessions
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.
Measured: At Study Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert H. Lurie Cancer Center
- Responsible party
- Sponsor
- Investigators
- Linda Emanuel, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074385
- Sponsor's protocol ID
- NU 09CC3
- Other IDs
- STU00022908, NCI-2010-01851
- Status last verified
- Sep 2013
- First submitted
- 22 Feb 2010
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dignity Therapy in Stage IV Colorectal Cancer Patients Receiving Chemotherapy to Increase Peaceful Awareness and Impact Goals of Care Decision-Making
- ClinicalTrials.gov ID
- NCT01074385
- Acronym / sponsor ID
- NU 09CC3
- Conditions
- Stage IV Colorectal Cancer
- Keywords
- Stage IV Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Robert H. Lurie Cancer Center
- Study start
- Apr 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Dignity Therapy | Other | Behavioral: Dignity TherapyAt 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. |
| Wait List Dignity Therapy | Other | Behavioral: Dignity TherapyAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dignity TherapyDignity 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. | Behavioural | Immediate Dignity Therapy, Wait List Dignity Therapy |
Primary outcome
Impact of Dignity Therapy
Time frame: at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of sessions
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.
2 secondary outcomes
Measure the impact of dignity therapy on life sustaining therapy and end-of-life goals of care.
Time frame: at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of dignity therapy sessions
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Emanuel, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dignity Therapy in people with Stage IV Colorectal Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Dignity Therapy (time frame: at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013.