- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04625439
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
419
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
Investigators
- 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)
November 18, 2020
Primary Completion (Actual)
February 8, 2021
Study Completion (Actual)
February 8, 2021
Study Registration Dates
First Submitted
November 3, 2020
First Submitted That Met QC Criteria
November 10, 2020
First Posted (Actual)
November 12, 2020
Study Record Updates
Last Update Posted (Actual)
March 2, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID 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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