NCT04625439

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
419

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable cancer

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

First Submitted

Initial submission to the registry

November 3, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

November 18, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2021

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

November 3, 2020

Last Update Submit

March 1, 2021

Conditions

Cancer

Outcome Measures

Primary Outcomes (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.

    pre-intervention and immediately post-intervention.

Secondary Outcomes (2)

  • PROMIS Self-Efficacy for Managing Chronic Conditions - Change Score

    pre-intervention and immediately post-intervention.

  • PANAS Positive Affect Subscale - Change Score

    pre-intervention and immediately post-intervention.

Study Arms (2)

Personality Feedback

EXPERIMENTAL

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

No-feedback Control

NO INTERVENTION

The control arm will read about the Five-Factor model but will not receive feedback or their personality results until after the study.

Interventions

Personality Feedback Self-Management InterventionBEHAVIORAL

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.

Personality Feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane University

New Orleans, Louisiana, 70118, United States

Location

Related Publications (1)

  • 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.

    PMID: 39547948DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Laura M Perry, MS

    Tulane University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 12, 2020

Study Start

November 18, 2020

Primary Completion

February 8, 2021

Study Completion

February 8, 2021

Last Updated

March 2, 2021

Record last verified: 2021-03

Locations

US(1)