Pancreatic CancerNCT02132325
Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
A study testing Dignity Therapy in people with Pancreatic Cancer and Non-Small-Cell Lung Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will evaluate feasibility and acceptability of providing the Dignity Therapy/Life Plan intervention to pancreatic or advanced lung cancer patients presenting for treatment in the outpatient medical oncology setting. Investigators hypothesize that providing dignity therapy to this population will be feasible. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreatic Cancer, Non-Small-Cell Lung 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
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 5 Feb 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Undergoing chemotherapy for pancreatic adenocarcinoma or advanced NSCLC (pancreatic arm closed)
- English-speaking
- Cognitively intact, per clinician judgment, as documented in electronic medical record (EMR)
Who cannot join
- Currently receiving hospice or palliative care services
- Concurrent diagnosis of delirium or dementia, per medical record
- Diagnosis of major depression disorder, acute anxiety disorder or schizophrenia per medical record
- Participating in other psychosocial intervention research studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/IIA: Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
This study will evaluate feasibility and acceptability of providing the Dignity Therapy/Life Plan intervention to pancreatic or advanced lung cancer patients presenting for treatment in the outpatient medical oncology setting. Investigators hypothesize that providing dignity therapy to this population will be feasible.
- Conditions
- Pancreatic Cancer, Non-Small-Cell Lung Cancer
- Being tested
- Dignity Therapy
- Keywords
- Pancreatic Cancer, Dignity Therapy, Palliative Care, Advanced Lung Cancer, Non-Small-Cell Lung Cancer
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dignity TherapyBehavioural
Dignity Therapy/Life Plan will be provided by an advanced practice nurse or chaplain (APN/Chap), who has undergone training in provision of Dignity Therapy (offered through a 3-day group workshop by Dr. Harvey Chochinov).
| Study group | Role | What they receive |
|---|---|---|
| Dignity Therapy | Experimental | Not described Receives: Behavioral: Dignity Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of distress as measured by distress scores on the Distress Thermometer
Measured: Baseline & at the end of the dignity therapy intervention (approximately 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startApr 2014
- Primary completion5 Feb 2018
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann (Ann Marie) M. Dose, R.N., Ph.D., Mayo Clinic
- Investigators
- Ann Marie Dose, PhD, RN, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132325
- Sponsor's protocol ID
- 14-001857
- Status last verified
- Mar 2018
- First submitted
- 1 May 2014
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A clean, deidentified data set will be made available to qualified requestors at study completion/dissemination.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIA: Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT02132325
- Acronym / sponsor ID
- 14-001857
- Conditions
- Pancreatic Cancer, Non-Small-Cell Lung Cancer
- Keywords
- Pancreatic Cancer, Dignity Therapy, Palliative Care, Advanced Lung Cancer, Non-Small-Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 7 May 2014 (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.
This study will evaluate feasibility and acceptability of providing the Dignity Therapy/Life Plan intervention to pancreatic or advanced lung cancer patients presenting for treatment in the outpatient medical oncology setting. Investigators hypothesize that providing dignity therapy to this population will be feasible.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dignity Therapy | Experimental | Behavioral: Dignity Therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18
- Undergoing chemotherapy for pancreatic adenocarcinoma or advanced NSCLC (pancreatic arm closed)
- English-speaking
- Cognitively intact, per clinician judgment, as documented in electronic medical record (EMR)
Key exclusion criteria (4 listed)
- Currently receiving hospice or palliative care services
- Concurrent diagnosis of delirium or dementia, per medical record
- Diagnosis of major depression disorder, acute anxiety disorder or schizophrenia per medical record
- Participating in other psychosocial intervention research studies.
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/Life Plan will be provided by an advanced practice nurse or chaplain (APN/Chap), who has undergone training in provision of Dignity Therapy (offered through a 3-day group workshop by Dr. Harvey Chochinov). | Behavioural | Dignity Therapy |
Primary outcome
Change in level of distress as measured by distress scores on the Distress Thermometer
Time frame: Baseline & at the end of the dignity therapy intervention (approximately 6 weeks)
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 21 Mar 2018.
- Individual participant dataSharing planned: Yes. A clean, deidentified data set will be made available to qualified requestors at study completion/dissemination.
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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.
Ann Marie Dose, PhD, RN principal investigator
Mayo Clinic
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 Pancreatic Cancer and Non-Small-Cell Lung Cancer, run by Mayo Clinic 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?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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 21 Mar 2018. 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?
Change in level of distress as measured by distress scores on the Distress Thermometer (time frame: Baseline & at the end of the dignity therapy intervention (approximately 6 weeks)). 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 21 Mar 2018.