Personality and Cancer Care Study

March 1, 2021 updated by: Laura Perry, Tulane University

Personality and Cancer Care Study: Examining the Effects of a Personality Feedback Intervention in Adults With Cancer

This randomized clinical trial will test whether giving an individualized personality feedback report to adults with a history of cancer can improve their self-awareness, confidence in managing their illness, and mood.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a randomized clinical trial examining whether a personality feedback intervention can improve three outcomes in an online sample of adults with cancer: 1) self-awareness, 2) self-efficacy for managing aspects of their illness, and 3) mood. The study will occur in a single 30-minute online session conducted in Qualtrics, with a pre-post randomized design. Participants will respond to a baseline survey including a measurement of the Five-Factor Personality Model and measures of the 3 outcomes of interest, followed by random assignment to either an intervention group or control group. Both groups will read a brief description of the Five-Factor Model of Personality. Those randomized to the intervention group will also receive an individualized feedback report containing their personality results on each of the five personality factors and recommendations for cancer self-management based on these results. After reading the personality information, participants will respond to the outcome measures again in a post-intervention survey. Control participants will receive their individualized personality feedback reports after the study is complete.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
419

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Tulane University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • consent to participate
  • at least 18 years old (self-reported)
  • have a current or past cancer diagnosis (self-reported)

Exclusion Criteria:

  • under 18 years old (self-reported)
  • indicate that they have no known history of cancer (self-reported)
  • unable to read or understand English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Personality Feedback
The intervention arm will read about the Five-Factor model and receive a feedback report with individualized personality results and self-management recommendations.
Behavioral: Personality Feedback Self-Management Intervention
The intervention is a personality feedback report that will tell participants whether they scored low (bottom third), average (middle third), or high (top third) on each of the five factor personality characteristics based on gender-matched norms. In addition to a description of general tendencies based on their level of each personality trait, the feedback will include information about how scoring in a given category may relate to an individual's cancer self-management or healthcare decision making. The feedback for each personality trait will include recommendations for how to improve key outcomes.
No Intervention: No-feedback Control
The control arm will read about the Five-Factor model but will not receive feedback or their personality results until after the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-Awareness Outcomes Questionnaire - Change Score
Time Frame: pre-intervention and immediately post-intervention.
Participants' current state-level self-awareness will be assessed with a modified 6-item short form of the Reflective Self-Development subscale included in the Self-Awareness Outcomes Questionnaire (SAOQ). Participants rate each item from 1 to 5, and a total score will be calculated by summing participants responses to each item. The total score at each time point will range from 6 to 30, with higher scores indicating higher levels of self-awareness. The difference score from pre-intervention to post-intervention will be used in analyses, with higher scores indicating a greater increase in self-awareness.
pre-intervention and immediately post-intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PROMIS Self-Efficacy for Managing Chronic Conditions - Change Score
Time Frame: pre-intervention and immediately post-intervention.
Participants will respond to three 4-item custom short forms from the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions Domain: 1) self-efficacy for managing emotions, 2) self-efficacy for managing symptoms, and 3) self-efficacy for managing medications and treatment. Each item is rated from 1 to 5, with raw scores on a summated total scale for each subscale ranging from 4 to 20. Each subscale's raw total score will be converted to a T-score, and a mean composite T-score across the 3 subscales will be calculated for each time point. Higher scores indicate higher levels of self-efficacy for managing their illness. For analyses, the difference in the mean T-score from pre-intervention to post-intervention will be computed, with higher scores indicating a greater increase in self-efficacy for managing their illness.
pre-intervention and immediately post-intervention.
PANAS Positive Affect Subscale - Change Score
Time Frame: pre-intervention and immediately post-intervention.
The 10-item positive affect scale from the Positive and Negative Affect Schedule (PANAS) will be used to assess current mood. Participants rate each item from 1 to 5, and a total summated scale score will range from 10 to 50, with higher scores indicating higher levels of positive affect. For analyses, the difference score from pre-intervention to post-intervention will be calculated, with higher scores indicating a greater increase in positive mood.
pre-intervention and immediately post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tulane University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura M Perry, MS, Tulane University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-909

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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