Health TrialsbyHealthPanel

Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors

ConditionsObesitySmoking CessationPhysical Inactivity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

The goal of this clinical trial is to improve cancer patient's health, survival, and quality of life by dispelling risk behaviors for Northwestern Memorial Health Care (NMHC) patients who are cancer survivors.

The main question\[s\] STELLAR aims to answer are:

* How best to combine three behavior interventions (physical activity promotion, smoking cessation, obesity treatment) into one treatment. * Evaluate the reach of the program. We will look at the number, proportion, and representativeness of participants in terms of disease characteristics, socioeconomic status, telehealth readiness, and race/ethnicity. * Evaluate the effects of the STELLAR program relative to enhanced usual care (information provision) on cancer risk behaviors, patient care access, care quality, and communication.

Participants will be provided goals related to their physical activity, smoking, and/or weight loss and asked to track their health behaviors via an app, excel file, or on paper. At baseline, 3 months, 6 months and 9 months into the study, participants will provide survey responses and physical measurements like height and weight. Additionally, those in the Facilitated group will complete 12 telehealth sessions with study staff to discuss progress towards their study goals.

Researchers will compare the Facilitated group to the Self Guided group to see if the Facilitated intervention group is able to reach more participants that enhances care only.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Northwestern Medicine patient

Over 18 years old

Engage in <150 min/week of physical activity

BMI of ≥25

Disqualifiers

Currently in another dietary, weight loss, smoking cessation (including cessation pharmacotherapy), or physical activity treatment/intervention.

Limited level of oral and written English or Spanish

Cognitively impaired adults

Prisoners

Trial design

Design model

Parallel

Treatments tested in this trial

  • multiple behavior change therapy

    Behavioral

    goals related to their physical activity, smoking, and/or obesity, and will be asked to meet those goals weekly/daily. Participants will also be asked to record their weight, activity, and/or cigarette smoking daily, and will complete 16 telehealth sessions with study staff across the 12 months of the study. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and 12 months.

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: FACILITATED ProgramActive comparator 1 intervention
Group B: SELF GUIDED ProgramNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Effectiveness

Effectiveness will be primarily evaluated through effects on behavioral change, which will serve as the primary outcomes: For 7-day point-prevalence smoking abstinence at 6 months (self-report of any smoking even a puff in the 7 days before the 6- month follow-up visit). For continuous outcomes (e.g., weight loss) we will use linear regression models adjusting for baseline values. For moderate to vigorous physical activity, the outcome will be transformed (e.g., logarithmically) to stabilize the variance and to satisfy the normality assumption. Secondary analyses for each outcome will adjust for the number or combination of risk factors.

Time frame
6 Months

Secondary outcomes

1

Reach

A) We will evaluate the Reach of the risk behavior screening system by assessing the number of cancer survivors exposed to EHR screening and the proportion and representativeness of those who enroll in the study and are randomized. B) We will also evaluate the Reach of the STELLAR intervention by assessing the proportion and representativeness (in terms of disease characteristics, socioeconomic status, telehealth access, technology literacy, race/ethnicity, and insurance status) of those randomized to active intervention who attend at least one treatment session.

Time frame
Baseline
2

Smoking

Assessed using Timeline Followback interview, participants who report any smoking, even a puff, in the 7 days prior to the visit will be classified as a person that currently smokes

Time frame
baseline, 3, 6 and 9 months
3

Body Weight

patient reported body weight in lbs.

Time frame
baseline, 3, 6 and 9 months
4

Self-Reported Weekly Amount (in days and minutes) of Moderate Intensity Physical Activity

Patient-reported weekly amount of moderate intensity physical activity in days and minutes will be assessed at each time point. Participants will be asked in the last 7 days, how many days they engaged in moderate intensity activity. Then on the days they were active, about how many minutes they were active (Less than 30 Minutes; 30 minutes to less than 1 hour; 1 hour to less than 1.5 hours; 1.5 hours to less than 2 hours; 2 hours to less than 2.5 hours; Over 2.5 hours)

Time frame
baseline, 3, 6 and 9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
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