NCT04866758

Brief Summary

The goal of this project is to assess the feasibility of collecting physiological and psychological data that will allow for preliminary investigation of predictors of suicidal ideation in an ambulatory cancer population already seeking psychosocial support.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.7 years

First QC Date

September 3, 2020

Last Update Submit

September 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Suicidal Ideation Information

    To evaluate the feasibility of data collection regarding physiological and psychological factors influencing suicidal ideation in cancer survivors

    duration of study, no more than 2 weeks

Secondary Outcomes (12)

  • Pain Intensity

    duration of study, no more than 2 weeks

  • Pain Interference

    duration of study, no more than 2 weeks

  • Symptom Burden/Severity

    duration of study, no more than 2 weeks

  • Physical Functioning

    duration of study, no more than 2 weeks

  • Health Related Quality of Life

    duration of study, no more than 2 weeks

  • +7 more secondary outcomes

Other Outcomes (1)

  • Suicidality

    2 years

Study Arms (1)

Cancer Survivors

Ambulatory cancer population already seeking psychosocial support.

Other: Survey

Interventions

SurveyOTHER

All data gathered will be quantitative in nature. In addition to participant completed surveys, additional demographic, and diagnosis/treatment related information will be collected from the patient's electronic medical record via Health Data Compass. Subsequent data collected as part of the patient's standard psychosocial and cancer related care (i.e., health outcomes, future utilization of UCCC psychosocial services) will also be gathered. This subsequent data collection will not include further participation, but continued access to the patient's medical record. Protected health information collected for this project will include dates (e.g., birth dates, date of diagnosis, date since last treatment, death dates) and participant zip codes. No other identifiable data will be collected. A separate survey emailed to the participant at the end of the study will collect information regarding the participant's completion status of the survey.

Cancer Survivors

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

An individual who fails to meet any of the inclusion criteria will be excluded from participation in this study. Mental health providers recruiting for this study may also use clinical judgment regarding appropriateness of participant for study (e.g., psychiatrically unstable).

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Provision to sign and date the consent form.
  • Stated willingness to comply with all study procedures and be available for the duration of the study.
  • Be male or female, aged 18 or older.
  • Ambulatory oncology patients at the University of Colorado Cancer Center who are being provided psychosocial support services; specifically, having had at least one in-person meeting with a doctoral level clinical/counseling psychologist or masters level social worker.
  • Valid and private email account.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jamie Studts, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

April 30, 2021

Study Start

June 2, 2017

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations