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CancerNCT04625439

Personality and Cancer Care Study

A study testing Personality Feedback Self-Management Intervention in people with Cancer, run by Tulane University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Personality Feedback Self-Management Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
419 participants
Where
1 siteUnited States
Study dates
18 Nov 2020to 8 Feb 2021
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tulane University

    New Orleans, Louisiana, 70118

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Cancer
Being tested
Personality Feedback Self-Management Intervention
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personality Feedback Self-Management InterventionBehavioural

    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.

Study groups in NCT04625439
Study groupRoleWhat they receive
Personality FeedbackExperimentalThe intervention arm will read about the Five-Factor model and receive a feedback report with individualized personality results and self-management recommendations.
Receives: Behavioral: Personality Feedback Self-Management Intervention
No-feedback ControlNo interventionThe control arm will read about the Five-Factor model but will not receive feedback or their personality results until after the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-Awareness Outcomes Questionnaire - Change Score

    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.

    Measured: pre-intervention and immediately post-intervention.

Secondary outcomes (2)

  1. PROMIS Self-Efficacy for Managing Chronic Conditions - Change Score

    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.

    Measured: pre-intervention and immediately post-intervention.

  2. PANAS Positive Affect Subscale - Change Score

    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.

    Measured: pre-intervention and immediately post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start18 Nov 2020
  3. Primary completion8 Feb 2021
  4. Study completion8 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04625439
Sponsor's protocol ID
2020-909
Status last verified
Mar 2021
First submitted
3 Nov 2020
Last updated
2 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Perry LM, Mossman B, Garcia SF, Kircher SM, Dunn A, Alonzi S, Easwar S, Hoerger M. Personality Feedback With Tailored Self-Care Recommendations Improves Self-Efficacy for Cancer Management: A Randomized Controlled Trial. Psychooncology. 2024 Nov;33(11):e70023. doi: 10.1002/pon.70023.

    PubMed 39547948

Questions about this trial

What is this clinical trial studying?

A study testing Personality Feedback Self-Management Intervention in people with Cancer, run by Tulane University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Mar 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Self-Awareness Outcomes Questionnaire - Change Score (time frame: pre-intervention and immediately post-intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04625439, which also lists 1 linked publication.

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 2 Mar 2021.

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