NCT05471284

Brief Summary

The objective of this study was to conduct a pilot factorial randomized trial to identify the message frames that are most effective in promoting participation in a tobacco treatment trial for current smokers recently diagnosed with cancer. To do so, we used a multimethod approach to evaluate 3 different message frames across evaluation, effectiveness, and outcome measures. We combine findings from a message design experiment with textual analytic software to provide a holistic understanding of how message frames may or may not differentially affect tobacco treatment trial participation within the context of a cancer diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 13, 2022

Last Update Submit

July 20, 2022

Conditions

Keywords

CancerDigital outreachMultimethod randomized trialFactorial DesignMessage FramesTobacco useSmoker enrollment rates

Outcome Measures

Primary Outcomes (1)

  • Difference in intent to talk to a physician about participating in a smoking cessation study between factors.

    The main effect within each message factor level was examined using ANOVA and compared with the control condition.

    Within 30 minutes

Secondary Outcomes (1)

  • Predictors of intent to talk to a physician about participating in a smoking cessation study.

    Within 30 minutes

Study Arms (9)

Control

SHAM COMPARATOR

The control condition was a kernel message that included study information present in all conditions but did not include any of the message factors.

Behavioral: Control

Proximal x Cost x Loss

EXPERIMENTAL

Message frame: proximal threats of smoking, cost of continued smoking, and loss of not participating in a tobacco treatment trial.

Behavioral: ProximalBehavioral: CostBehavioral: Loss

Proximal x Cost x Gain

EXPERIMENTAL

Message frame: proximal threats of smoking, cost of continued smoking, and gain of participating in a tobacco treatment trial.

Behavioral: ProximalBehavioral: CostBehavioral: Gain

Proximal x Benefit x Gain

EXPERIMENTAL

Message frame: proximal threats of smoking, benefits of quitting, and gain of participating in a tobacco treatment trial.

Behavioral: ProximalBehavioral: BenefitBehavioral: Gain

Proximal x Benefit x Loss

EXPERIMENTAL

Message frame: proximal threats of smoking, benefits of quitting, and loss of not participating in a tobacco treatment trial.

Behavioral: ProximalBehavioral: BenefitBehavioral: Loss

Distal x Cost x Gain

EXPERIMENTAL

Message frame: distal threats of smoking, cost of continued smoking, and gain of participating in a tobacco treatment trial.

Behavioral: DistalBehavioral: CostBehavioral: Gain

Distal x Cost x Loss

EXPERIMENTAL

Message frame: distal threats of smoking, cost of continued smoking, and loss of not participating in a tobacco treatment trial.

Behavioral: DistalBehavioral: CostBehavioral: Loss

Distal x Benefit x Loss

EXPERIMENTAL

Message frame: distal threats of smoking, benefits of quitting, and loss of not participating in a tobacco treatment trial.

Behavioral: DistalBehavioral: BenefitBehavioral: Loss

Distal x Benefit x Gain

EXPERIMENTAL

Message frame: distal threats of smoking, benefits of quitting, and gain of participating in a tobacco treatment trial.

Behavioral: DistalBehavioral: BenefitBehavioral: Gain

Interventions

ProximalBEHAVIORAL

The first factor tested framing of the near, proximal threat of continued smoking.

Proximal x Benefit x GainProximal x Benefit x LossProximal x Cost x GainProximal x Cost x Loss
DistalBEHAVIORAL

The first factor tested framing of the long-term, distal threat of continued smoking.

Distal x Benefit x GainDistal x Benefit x LossDistal x Cost x GainDistal x Cost x Loss
CostBEHAVIORAL

Cost framework measures the response efficacy to quitting smoking by displaying costs of continued smoking.

Distal x Cost x GainDistal x Cost x LossProximal x Cost x GainProximal x Cost x Loss
BenefitBEHAVIORAL

Benefit framework measures the response efficacy to quitting smoking by displaying benefits of quitting.

Distal x Benefit x GainDistal x Benefit x LossProximal x Benefit x GainProximal x Benefit x Loss
LossBEHAVIORAL

The third factor tested framing of the response efficacy of participating in a cessation study by utilizing loss of not participating in a smoking cessation.

Distal x Benefit x LossDistal x Cost x LossProximal x Benefit x LossProximal x Cost x Loss
GainBEHAVIORAL

The third factor tested framing of the response efficacy of participating in a cessation study by utilizing gain of participating in a smoking cessation.

Distal x Benefit x GainDistal x Cost x GainProximal x Benefit x GainProximal x Cost x Gain
ControlBEHAVIORAL

Does not include any of the three message factors.

Control

Eligibility Criteria

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

You may qualify if:

  • Speak and understand English
  • A recent cancer diagnosis (within the past 24 months)
  • years or older
  • Report any cigarette use within the past 30 days

You may not qualify if:

  • Do not speak or understand English
  • Have not been diagnosed with cancer within the past 24 months
  • Below the age of 18
  • Does not report any cigarette use within the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan Neil

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • Neil JM, Senecal C, Ballini L, Chang Y, Goshe B, Flores E, Ostroff JS, Park ER. A Multimethod Evaluation of Tobacco Treatment Trial Recruitment Messages for Current Smokers Recently Diagnosed With Cancer: Pilot Factorial Randomized Controlled Trial. JMIR Cancer. 2022 Aug 24;8(3):e37526. doi: 10.2196/37526.

MeSH Terms

Conditions

Tobacco SmokingHealth BehaviorNeoplasmsTobacco Use

Interventions

Costs and Cost AnalysisGain of Function Mutation

Condition Hierarchy (Ancestors)

SmokingBehavior

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and OrganizationsMutationGenetic VariationGenetic Phenomena

Study Officials

  • Jordan Neil, Ph.D.

    TSET Health Promotion Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 22, 2022

Study Start

February 11, 2019

Primary Completion

April 1, 2019

Study Completion

April 2, 2019

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations