- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03840109
Emotional Support Messages Following a Cancer Diagnosis
November 24, 2020 updated by: H. Lee Moffitt Cancer Center and Research Institute
Cancer patients will be randomly shown one of 18 emotional support messages created by the research team that differ based on how much of the message consists of positive statements and how much consists of negative statements.
The messages with negative statements also differ based on whether the negative statements occur at the start or end of the message.
After viewing the message, participants have the opportunity to rate the effectiveness of the message, to what extent the message made them feel better, and to what extent the message affects how they view the message provider as a useful source of emotional support.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
417
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
-
-
Florida
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
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
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult cancer patients
Description
Inclusion Criteria:
- Participants must be 18 years of age or older
- Participants with a diagnosis of breast, prostate, thoracic or digestive cancer in the past 3 years
- Participants consented to Moffitt's Total Cancer Care (TCC) protocol and indicating a willingness to be contacted for future research by including an email contact.
- Ability to read and write fluently in 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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
All Participants
All participants will take an online questionnaire which includes their evaluation of one of 18 different emotional support messages randomly assigned through the Qualtrics survey system.
The participants answer a series of closed ended scales regarding quality of the support message, supporter's competence, amount of emotional improvement they experienced after reading the message, and likelihood to seek support from the person writing the message.
|
Participants will be randomly shown two versions of messages in which the last 20% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
Participants will be randomly shown two versions of messages in which the first 20% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
Participants will be randomly shown two versions of messages in which the last 40% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
Participants will be randomly shown two versions of messages in which the first 40% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
Participants will be randomly shown two versions of messages in which the last 60% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
Participants will be randomly shown two versions of messages in which the first 60% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
Participants will be randomly shown two versions of messages in which the last 80% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
Participants will be randomly shown two versions of messages in which the first 80% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Message Effectiveness Scale
Time Frame: Through study completion, up to 1 year
|
Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of perceived message effectiveness.
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Through study completion, up to 1 year
|
Affective Improvement Scale
Time Frame: Through study completion, up to 1 year
|
Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of self-reports of emotional improvement.
|
Through study completion, up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Supporter Competence Scale
Time Frame: Through study completion, up to 1 year
|
Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of perceptions of supporter competence.
|
Through study completion, up to 1 year
|
Likelihood of Seeking Support Scale
Time Frame: Through study completion, up to 1 year
|
Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of their likelihood to seek support from the supporter in the future.
|
Through study completion, up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maija Reblin, PhD, H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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)
January 30, 2019
Primary Completion (Actual)
May 10, 2019
Study Completion (Actual)
November 24, 2020
Study Registration Dates
First Submitted
February 11, 2019
First Submitted That Met QC Criteria
February 12, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
November 25, 2020
Last Update Submitted That Met QC Criteria
November 24, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-19957
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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