NCT05790278

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

March 10, 2023

Last Update Submit

February 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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").

    Through Study Completion, about 15 minutes

Secondary Outcomes (3)

  • Work and Adjustment Scale

    Through Study Completion, about 15 minutes

  • Meaning in Life Questionnaire

    Through Study Completion, about 15 minutes

  • Life Engagement Test

    Through Study Completion, about 15 minutes

Study Arms (3)

Adults with Early Stage Cancer

Other: Survey

Adults with Traumatic Brain Injury

Other: Survey

Health Control Adults

Other: Survey

Interventions

SurveyOTHER

Completion of a Purpose in Life Survey

Adults with Early Stage CancerAdults with Traumatic Brain InjuryHealth Control Adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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;
  • 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

You may not qualify if:

  • Have declined consent for use of medical records in research during admission to AH facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBrain Injuries, Traumatic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Mary V Radomski, PhD

    Allina Health - Courage Kenny Rehabilitation Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 30, 2023

Study Start

August 1, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2024

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations