Psychological StressNCT03840109
Emotional Support Messages Following a Cancer Diagnosis
An observational study of Psychological Stress and Anxiety, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Stress, Anxiety
- What is being tested?
- Questionnaire 1a, Questionnaire 1b and Questionnaire 2a
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 417 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2019to 24 Nov 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Adult cancer patients
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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.
- Conditions
- Psychological Stress, Anxiety
- Being tested
- Questionnaire 1a, Questionnaire 1b, Questionnaire 2a, Questionnaire 2b, Questionnaire 3a
- Keywords
- emotional support, cancer
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire 1aBehavioural
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 1bBehavioural
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 2aBehavioural
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 2bBehavioural
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 3aBehavioural
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 3bBehavioural
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 4aBehavioural
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 4bBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaire 1a; Behavioral: Questionnaire 1b; Behavioral: Questionnaire 2a; Behavioral: Questionnaire 2b; Behavioral: Questionnaire 3a; Behavioral: Questionnaire 3b; Behavioral: Questionnaire 4a; Behavioral: Questionnaire 4b |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 1 year
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.
Measured: Through study completion, up to 1 year
Secondary outcomes (2)
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.
Measured: Through study completion, up to 1 year
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.
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start30 Jan 2019
- Primary completion10 May 2019
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maija Reblin, PhD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840109
- Sponsor's protocol ID
- MCC-19957
- Status last verified
- Nov 2020
- First submitted
- 11 Feb 2019
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Support Messages Following a Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT03840109
- Acronym / sponsor ID
- MCC-19957
- Conditions
- Psychological Stress, Anxiety
- Keywords
- emotional support, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- San Diego State University, University of Arizona, University of Minnesota
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Behavioral: Questionnaire 1a, Behavioral: Questionnaire 1b, Behavioral: Questionnaire 2a, Behavioral: Questionnaire 2b, Behavioral: Questionnaire 3a, Behavioral: Questionnaire 3b, Behavioral: Questionnaire 4a, Behavioral: Questionnaire 4bAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult cancer patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire 1aParticipants 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. | Behavioural | All Participants |
| Questionnaire 1bParticipants 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. | Behavioural | All Participants |
| Questionnaire 2aParticipants 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. | Behavioural | All Participants |
| Questionnaire 2bParticipants 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. | Behavioural | All Participants |
| Questionnaire 3aParticipants 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. | Behavioural | All Participants |
| Questionnaire 3bParticipants 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. | Behavioural | All Participants |
| Questionnaire 4aParticipants 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. | Behavioural | All Participants |
| Questionnaire 4bParticipants 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. | Behavioural | All Participants |
Primary outcome
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.
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.
2 secondary outcomes
Supporter Competence Scale
Time frame: Through study completion, up to 1 year
Likelihood of Seeking Support Scale
Time frame: Through study completion, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Moffitt Cancer Center Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maija Reblin, PhD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Stress and Anxiety, run by H. Lee Moffitt Cancer Center and Research Institute 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 4 inclusion and 0 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 25 Nov 2020. 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?
Message Effectiveness Scale (time frame: Through study completion, up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2020.