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

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

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

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

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

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

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

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

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

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

Proximal

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

Distal

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

Cost

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

Benefit

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.

Loss

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

Gain

Does not include any of the three message factors.

Control

Jordan Neil, Ph.D.

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.

Background: A cancer diagnosis can catalyze motivation to quit smoking. Tobacco treatment trials offer cessation resources but have low accrual rates. Digital outreach may improve accrual, but knowledge of how best to recruit smokers with recent diagnoses is limited.

Objective: This study aims to identify the message frames that were most effective in promoting intent to talk to a physician about participating in a tobacco treatment trial for smokers recently diagnosed with cancer.

Methods: From February to April 2019, current smokers diagnosed within the past 24 months were recruited from a national web-based panel for a multimethod pilot randomized trial (N=99). Participants were randomized to a 2×3 plus control factorial design that tested 3 unique message frames: proximal versus distal threats of smoking, costs of continued smoking versus benefits of quitting, and gains of participating versus losses of not participating in a tobacco treatment trial.

Recruitment Messages for Current Smokers Recently Diagnosed With Cancer

A Multimethod Evaluation of Tobacco Treatment Trial Recruitment Messages for Current Smokers Recently Diagnosed With Cancer: Pilot Factorial Randomized Controlled Trial

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

Other message evaluation and effectiveness measures were collected and explored in a multivariable model predicting intent to talk to a physician.

Tufts University

Massachusetts General Hospital

Memorial Sloan Kettering Cancer Center

University of Oklahoma

3 in-person/telephone weekly sessions on providing decision social support, tips for good communication, and decision support tools

2 in-person/telephone weekly sessions on providing decision social support and tips for good communication

2 in-person/telephone weekly sessions on providing decision social support and decision support tools

1 in-person/telephone weekly session on providing decision social support

5 in-person/telephone weekly sessions on providing decision social support, tips for good communication, and decision support tools

4 in-person/telephone weekly sessions on providing decision social support and tips for good communication

4 in-person/telephone weekly sessions on providing decision social support and decision support tools

3 in-person/telephone weekly sessions on providing decision social support

CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, nurse coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training.

CASCADE (CAre Supporters Coached to be Adept DEcision partners)

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, for the first time, an optimization trial approach to develop and refine the decision partnering skills of family caregivers of persons with newly-diagnosed advanced cancer. Using a 2x2x2 full factorial design, 40 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more nurse coach-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory4: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision partnering communication training (yes vs. no); and 3) Ottawa Decision Guide training (yes vs. no).

A priority focus in palliative care, oncology, and geriatrics is preparing the 2.8 million U.S. family caregivers of persons with cancer to effectively partner with patients in healthcare decision-making from diagnosis to the end of life. Over 70% of patients with cancer report involvement by relatives, friends, and partners in healthcare decisions, including choices about cancer treatments, surgery, transitions and location of care, accessing palliative and hospice care, and many others. Hence, there is a critical need to train cancer family caregivers to be supportive of patient decision-making; however, few palliative care interventions exist that enhance skills in effective decision partnering. Patients making healthcare decisions with unprepared family caregivers may experience inadequate family decision support leading to heightened distress and receipt of care/treatments inconsistent with their values and preferences. This in turn may increase distress for family caregivers.

Becoming better decision partners with patients is one among several skills targeted within our evidence-based model of early concurrent oncology palliative care for family caregivers. Decision partnering relevant content for family caregivers has included principles of effective social support, communication, and Ottawa Decision Guide training; however it is unknown which of these components and component interactions influences patient and caregiver decision-making outcomes. Traditional research approaches typically treat interventions as "bundled" treatment packages, making it difficult to assess definitively which aspects of an intervention can be reduced, eliminated, or replaced to improve efficiency. Using traditional research methods (e.g., two-arm randomized controlled trials that test new features one at a time) requires conducting multiple studies, which is an exorbitantly expensive and time consuming process. This paradox prompts us to consider methodologies that may offer a more efficient way to test multiple intervention components simultaneously.

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, for the first time, an optimization trial approach to develop and refine the decision partnering skills of family caregivers of persons with newly-diagnosed advanced cancer (CASCADE: CAre Supporters Coached to be Adept DEcision partners). Using a 2x2x2 factorial design, 40 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more nurse coach-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory4: 1) psychoeducation on effective decision partnering and social support principles (1 vs. 3 sessions); 2) decision support communication training (yes vs. no); and 3) Ottawa Decision Guide training (yes vs. no).

This study's conceptual foundations incorporate Rini's Social Support Effectiveness Theory and the Ottawa Decision Support Framework. Caregiver decision partnering training is designed to modify family caregiver skills, including their ability to: 1) provide effective social support through psychoeducation on key social support principles that will optimize emotional and informational support to patients; 2) elicit patient decisional needs, including patient values, preferences, and coping through better decision support communication, enhancing the quantity of decision-making conversations; and 3) provide structured decision support using an evidence-based tool (i.e., the Ottawa Decision Guide, see Appendix) to help patients clarify choices and guide deliberation through Ottawa decision guide training, reducing patient decision conflict. Modification of these skills and improvement in patient mediating outcomes is hypothesized to lead to more positive decisional influence from the patient's perspective and better patient and caregiver mood.

The specific aims of this study are to:

Aim 1: Determine the feasibility and acceptability of using a highly innovative experimental design to enroll and retain 40 caregivers for 24 weeks to complete 1 or more components of caregiver decision partnering training. Feasibility: ≥80% of participants will adhere to and complete assigned intervention components and study-related assessments. Acceptability: Through post-intervention qualitative interviews, the investigators will elicit feedback from caregiver participants on intervention experiences and clinical trial procedures.

Aim 2: Explore the preliminary efficacy of individual decision partnering training components and component interactions on patient and caregiver outcomes at 12 and 24 weeks after baseline, including a) patient-reported positive decision influence (primary) using Rini's Decision Influence Scale and b) patient and caregiver mood (depression/anxiety symptoms) using the Hospital Anxiety and Depression Scale.

Exploratory Aim: Explore mediators and moderators (e.g., sociodemographics, coping, social support, decisional conflict) of the relationship between intervention components and patient and caregiver outcomes.

2x2x2 full factorial pilot randomized trial

Data collectors and principal investigator will be blind to participant condition; participants will be instructed NOT to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the nurse coach involved in delivering the intervention.

Pilot Optimization Trial of Decision Partnering Intervention for Advanced Cancer Family Caregivers

An Optimization Trial to Prepare Advanced Cancer Caregivers for Decision Partnering Using the Multiphase Optimization Strategy (MOST)

Proportion of caregiver participants who complete assigned intervention components and proportion of caregiver and patient participants who complete study-related assessments.

Through qualitative interviews, caregiver participant reported experiences with the CASCADE intervention and trial procedures.

30 items; assesses satisfaction with how family caregivers assist patient's with healthcare decision-making, such as acting angry, questioning or doubting the patient's decisions, failing to assist, making useful suggestions, listening, and offering helpful advice. Total score range: 37-185; higher scores=more positive decision influence by family member.

14 items; measures symptoms of anxiousness and depressed mood. 7 items measure anxiety (e.g., feeling tense, restless, worried) and 7 items measure depressive symptoms (e.g., cheerfulness, feeling slowed down. Subscale score ranges: 0-21; higher scores=worse anxiety or depressive symptoms. Total score range: 0-42; higher scores=worse overall distress.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Recruitment Messages for Current Smokers Recently Diagnosed With Cancer	NCT05471284	Tobacco Smoking Health Behavior	Proximal Distal Cost Benefit Loss Gain Control	18 Years -	University of Oklahoma
Pilot Optimization Trial of Decision Partnering Intervention for Advanced Cancer Family Caregivers	NCT03947606	Family Caregive... Cancer	CASCADE (CAre S...	18 Years -	University of Alabama at Birmingham

Spots Global Cancer Trial Database for factorial design