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

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.

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.
Observational

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.
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

  • United States
    • 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

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
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.
Behavioral: Questionnaire 1a
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.
Behavioral: Questionnaire 1b
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.
Behavioral: Questionnaire 2a
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.
Behavioral: Questionnaire 2b
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.
Behavioral: Questionnaire 3a
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.
Behavioral: Questionnaire 3b
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.
Behavioral: Questionnaire 4a
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.
Behavioral: Questionnaire 4b
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

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
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.
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

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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
San Diego State University
University of Minnesota
University of Arizona

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: 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)

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.
January 30, 2019

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.
May 10, 2019

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.
November 24, 2020

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).
February 11, 2019

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.
February 12, 2019

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.
February 15, 2019

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.
November 25, 2020

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.
November 24, 2020

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.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 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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