Breast CancerPILNCT05790278
Purpose in Life Survey
An observational study of Breast Cancer and Traumatic Brain Injury, run by Mary Radomski at 1 site in United States.
Trial summary
At present, there is no empirical data that specifies the likely prevalence of purpose in life disruption among various clinical populations. Between one-third and one-half of cancer survivors report some degree of existential distress during or after their treatment, but these findings are not specific to the domain… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Traumatic Brain Injury
- What is being tested?
- Survey
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Aug 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults who are either (1) healthy controls, (2) individuals with a qualifying cancer diagnosis, or (3) individuals with a qualifying Traumatic Brain Injury
Who may be able to join
- Age 18+
- Stage 1, 2, 3 cancer
- Cancer types: breast cancer, non-Hodgkin's lymphoma; colorectal cancer
- Receiving oncology services or treatment through AHCI
- Have completed primary cancer treatment within the past 12 months
- Able to communicate in English;
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- Able to see and read (with or without assistive devices);
- Has access to a device (computer, phone, tablet) and an email address;
- Access to an internet connection.
- Has a known email address (in EPIC) and/or home telephone number
- Adults who sustained a traumatic brain injury within the past 12 months.
- Attending the 2022 MN State Fair
Who cannot join
- Have declined consent for use of medical records in research during admission to AH facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
Official title: Evaluating the Prevalence of Purpose-related Existential Distress Among 2 Clinical Populations Compared to a Normative Sample
At present, there is no empirical data that specifies the likely prevalence of purpose in life disruption among various clinical populations. Between one-third and one-half of cancer survivors report some degree of existential distress during or after their treatment, but these findings are not specific to the domain of purpose in life.
To address the aforementioned gap, we propose to conduct a survey study to determine the prevalence of purpose disruption in two clinical populations and determine if the prevalence of purpose disruption in these populations is different from that of a normative population.
- Conditions
- Breast Cancer, Traumatic Brain Injury
- Being tested
- Survey
- Medical subject headings
- Breast Neoplasms, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Completion of a Purpose in Life Survey
| Study group | Role | What they receive |
|---|---|---|
| Adults with Early Stage Cancer | Not described Receives: Other: Survey | |
| Adults with Traumatic Brain Injury | Not described Receives: Other: Survey | |
| Health Control Adults | Not described Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purpose Status Question
A single forced-choice self-report screener question that we developed in order to characterize existential distress related to purpose in life (PSQ: "Related to living with purpose in life, right now I am: moving backwards; stalled; figuring it out; moving forward on a path").
Measured: Through Study Completion, about 15 minutes
Secondary outcomes (3)
Work and Adjustment Scale
A 5-item self-report questionnaire to characterize functioning related to work, social life, leisure, home management, and relationships.
Measured: Through Study Completion, about 15 minutes
Meaning in Life Questionnaire
A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).
Measured: Through Study Completion, about 15 minutes
Life Engagement Test
A 6-item self-report questionnaire that captures the extent to which a person engages in activities that are personally valued.
Measured: Through Study Completion, about 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Aug 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mary Radomski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary Radomski, Allina Health System
- Investigators
- Mary V Radomski, PhD, Principal investigator, Allina Health - Courage Kenny Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790278
- Sponsor's protocol ID
- 1920306
- Acronym
- PIL
- Status last verified
- Feb 2024
- First submitted
- 10 Mar 2023
- Last updated
- 5 Feb 2024
- 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 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Prevalence of Purpose-related Existential Distress Among 2 Clinical Populations Compared to a Normative Sample
- ClinicalTrials.gov ID
- NCT05790278
- Acronym / sponsor ID
- PIL / 1920306
- Conditions
- Breast Cancer, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mary RadomskiUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 30 Mar 2023 (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.
At present, there is no empirical data that specifies the likely prevalence of purpose in life disruption among various clinical populations. Between one-third and one-half of cancer survivors report some degree of existential distress during or after their treatment, but these findings are not specific to the domain of purpose in life.
To address the aforementioned gap, we propose to conduct a survey study to determine the prevalence of purpose disruption in two clinical populations and determine if the prevalence of purpose disruption in these populations is different from that of a normative population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adults with Early Stage Cancer | – | Other: Survey |
| Adults with Traumatic Brain Injury | – | Other: Survey |
| Health Control Adults | – | Other: Survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who are either (1) healthy controls, (2) individuals with a qualifying cancer diagnosis, or (3) individuals with a qualifying Traumatic Brain Injury
Key inclusion criteria (12 listed)
- Age 18+
- Stage 1, 2, 3 cancer
- Cancer types: breast cancer, non-Hodgkin's lymphoma; colorectal cancer
- Receiving oncology services or treatment through AHCI
- Have completed primary cancer treatment within the past 12 months
Key exclusion criteria (1 listed)
- Have declined consent for use of medical records in research during admission to AH facility
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 |
|---|---|---|
| SurveyCompletion of a Purpose in Life Survey | Other | Adults with Early Stage Cancer, Adults with Traumatic Brain Injury, Health Control Adults |
Primary outcome
Purpose Status Question
Time frame: Through Study Completion, about 15 minutes
A single forced-choice self-report screener question that we developed in order to characterize existential distress related to purpose in life (PSQ: "Related to living with purpose in life, right now I am: moving backwards; stalled; figuring it out; moving forward on a path").
3 secondary outcomes
Work and Adjustment Scale
Time frame: Through Study Completion, about 15 minutes
Meaning in Life Questionnaire
Time frame: Through Study Completion, about 15 minutes
Life Engagement Test
Time frame: Through Study Completion, about 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- 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.
Mary V Radomski, PhD principal investigator
Allina Health - Courage Kenny Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Traumatic Brain Injury, run by Mary Radomski 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 12 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Feb 2024. 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?
Results are not available in the source record.
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?
Purpose Status Question (time frame: Through Study Completion, about 15 minutes). 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 5 Feb 2024.