Advanced CancerNCT05113199
Virtual Dignity Therapy for Palliative Care Patients With Advanced Cancer
A study testing Virtual Dignity Therapy in people with Advanced Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if it is feasible and acceptable to recruit for and deliver the Virtual Dignity Therapy intervention to palliative care patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Virtual Dignity Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to 17 Feb 2025
- 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
Who may be able to join
- Age ≥18 years
- English fluency
- No diagnosed dementia
- Diagnosis of advanced cancer
- Expected prognosis > 6 months
- Provide informed consent
Show all 11Show fewer
- Ability to complete questionnaire(s) by themselves or with assistance
- Age ≥18 years
- English fluency
- Provide informed consent
- Supported patient through Dignity Therapy
Who cannot join
- Other psychological co-morbidities such as untreated schizophrenia, bipolar disease
- Recent suicide attempt or psychiatric illness severe enough that hospitalization has been necessary in last 6 months
- Active delirium
- Participation in concurrent legacy offerings through the palliative care clinic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Virtual Dignity Therapy for Palliative Care Patients With Advanced Cancer
The purpose of this study is to determine if it is feasible and acceptable to recruit for and deliver the Virtual Dignity Therapy intervention to palliative care patients with advanced cancer.
Read the detailed description
This study is an investigator-initiated, single site Mayo Clinic Rochester prospective minimal risk pilot study to determine feasibility and acceptability of Virtual Dignity Therapy. The Dignity Therapy intervention is a brief, individualized psychotherapy that aims to relieve psycho-emotional and existential distress and improve the experiences of patients whose lives are impacted by serious illness. This therapy offers patients an opportunity to reflect on their life with a trained facilitator and share their thoughts and memories with family and other people in their life. This therapy consists of a total of 3 sessions, with each session 2-4 weeks apart, in which the investigator provides questions focused on life review. The sessions are recorded and transcribed. The interventionist will work with patients to edit the document and provide a final generativity document for patient to keep and give to loved ones.
- Conditions
- Advanced Cancer
- Being tested
- Virtual Dignity Therapy
- Keywords
- Dignity Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Dignity TherapyBehavioural
Virtual Dignity Therapy will be facilitated by a registered nurse or medical doctor trained in Dignity Therapy.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Dignity Therapy | Experimental | Not described Receives: Behavioral: Virtual Dignity Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Number
Study feasibility will be measured by the number of participants who enrolled and finished the study.
Measured: 2 Years
Acceptability
Acceptability, as measured by the 7-item Was it Worth It (WIWI Questionnaire).The questions are answered as either "yes, no, or uncertain," overall perception of quality of life change, overall perception of study experience, one open-ended feedback question, and an option to talk with someone about concerns. Positive responses indicate acceptability. Results are reported as individual items.
Measured: Week 8 (after 3rd intervention session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start18 Nov 2021
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deirdre R. Pachman, Mayo Clinic
- Investigators
- Deirdre Pachman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113199
- Sponsor's protocol ID
- 21-005065
- Status last verified
- Feb 2025
- First submitted
- 30 Aug 2021
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Virtual Dignity Therapy for Palliative Care Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT05113199
- Acronym / sponsor ID
- 21-005065
- Conditions
- Advanced Cancer
- Keywords
- Dignity Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 9 Nov 2021 (actual)
- 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 determine if it is feasible and acceptable to recruit for and deliver the Virtual Dignity Therapy intervention to palliative care patients with advanced cancer.
Detailed description
This study is an investigator-initiated, single site Mayo Clinic Rochester prospective minimal risk pilot study to determine feasibility and acceptability of Virtual Dignity Therapy. The Dignity Therapy intervention is a brief, individualized psychotherapy that aims to relieve psycho-emotional and existential distress and improve the experiences of patients whose lives are impacted by serious illness. This therapy offers patients an opportunity to reflect on their life with a trained facilitator and share their thoughts and memories with family and other people in their life. This therapy consists of a total of 3 sessions, with each session 2-4 weeks apart, in which the investigator provides questions focused on life review. The sessions are recorded and transcribed. The interventionist will work with patients to edit the document and provide a final generativity document for patient to keep and give to loved ones.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Dignity Therapy | Experimental | Behavioral: Virtual Dignity Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years
- English fluency
- No diagnosed dementia
- Diagnosis of advanced cancer
- Expected prognosis > 6 months
Key exclusion criteria (4 listed)
- Other psychological co-morbidities such as untreated schizophrenia, bipolar disease
- Recent suicide attempt or psychiatric illness severe enough that hospitalization has been necessary in last 6 months
- Active delirium
- Participation in concurrent legacy offerings through the palliative care clinic
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 |
|---|---|---|
| Virtual Dignity TherapyVirtual Dignity Therapy will be facilitated by a registered nurse or medical doctor trained in Dignity Therapy. | Behavioural | Virtual Dignity Therapy |
Primary outcome
Feasibility Number
Time frame: 2 Years
Study feasibility will be measured by the number of participants who enrolled and finished the study.
Acceptability
Time frame: Week 8 (after 3rd intervention session)
Acceptability, as measured by the 7-item Was it Worth It (WIWI Questionnaire).The questions are answered as either "yes, no, or uncertain," overall perception of quality of life change, overall perception of study experience, one open-ended feedback question, and an option to talk with someone about concerns. Positive responses indicate acceptability. Results are reported as individual items.
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 3 Mar 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Deirdre Pachman, MD 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 Virtual Dignity Therapy in people with Advanced 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 11 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 3 Mar 2025. 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?
Feasibility Number (time frame: 2 Years). The study lists 2 primary outcomes in all. 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 3 Mar 2025.