Emotional Support Messages Following a Cancer Diagnosis

Anxiety Clinical Trial

Official title:

Emotional Support Messages Following a Cancer Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03840109
• Other study ID #: MCC-19957
• Status: Completed
• Start date: January 30, 2019
• Est. completion date: November 24, 2020

Study information

• Verified date: November 2020
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: November 24, 2020
• Est. primary completion date: May 10, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Psychological Stress
• Stress, Psychological

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (4)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	San Diego State University, University of Arizona, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Message Effectiveness Scale	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
Primary	Affective Improvement Scale	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	Supporter Competence Scale	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
Secondary	Likelihood of Seeking Support Scale	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

External Links

•   Moffitt Cancer Center Clinical Trials Website