Adapting an Efficacious Peer-Delivered Physical Activity Program for Survivors of Breast Cancer for Web Platform Delivery: Protocol for a 2-Phase Study.

BACKGROUND: Interventions promoting physical activity (PA) among survivors of cancer improve their functioning, reduce fatigue, and offer other benefits in cancer recovery and risk reduction for future cancer. There is a need for interventions that can be implemented on a wider scale than that is possible in research settings. We have previously demonstrated that a 3-month peer-delivered PA program (Moving Forward Together [MFT]) significantly increased the moderate to vigorous PA (MVPA) of survivors of breast cancer. OBJECTIVE: Our goal is to scale up the MFT program by adapting an existing peer mentoring web platform, Mentor1to1. InquistHealth's web platform (Mentor1to1) has demonstrated efficacy in peer mentoring for chronic disease management. We will partner with InquisitHealth to adapt their web platform for MFT. The adaptation will allow for automating key resource-intensive components such as matching survivors with a coach via the web-based peer mentoring platform and collecting key indexes to prepare for large-scale implementation. The aim is to streamline intervention delivery, assure fidelity, and improve survivor outcomes. METHODS: In phase 1 of this 2-phase study, we will interview 4 peer mentors or coaches with experience in delivering MFT and use their feedback to create Mentor1to1 web platform adapted for MFT (webMFT). Next, another 4 coaches will participate in rapid, iterative user-centered testing of webMFT. In phase 2, we will conduct a randomized controlled trial by recruiting and training 10 to 12 coaches from cancer organizations to deliver webMFT to 56 survivors of breast cancer, who will be assigned to receive either webMFT or MVPA tracking (control) for 3 months. We will assess effectiveness with survivors' accelerometer-measured MVPA and self-reported psychosocial well-being at baseline and 3 months. We will assess implementation outcomes, including acceptability, feasibility, and program costs from the perspective of survivors, coaches, and collaborating organizations, as guided by the expanded Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. RESULTS: As of September 2023, phase 1 of the study was completed, and 61 survivors were enrolled in phase 2. Using newer technologies for enhanced intervention delivery, program management, and automated data collection has the exciting promise of facilitating effective implementation by organizations with limited resources. Adapting evidence-based MFT to a customized web platform and collecting data at multiple levels (coaches, survivors, and organizations) along with costs will provide a strong foundation for a robust multisite implementation trial to increase MVPA and its benefits among many more survivors of breast cancer. CONCLUSIONS: The quantitative and qualitative data collected from survivors of cancer, coaches, and organizations will be analyzed to inform a future larger-scale trial of peer mentoring for PA delivered by cancer care organizations to survivors. TRIAL REGISTRATION: ClinicalTrials.gov NCT05409664; https://clinicaltrials.gov/study/NCT05409664. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52494.

Effects of a peer-led physical activity program on psychosocial outcomes among breast cancer survivors.

OBJECTIVE: To examine the effects of three programs aimed at maintaining moderate-to-vigorous physical activity (MVPA) on breast cancer survivors' quality of life, physical functioning, fatigue and mood. METHODS: 161 survivors participated in a 12-month randomized controlled study and were assigned to one of three groups: Reach Plus, Reach Plus Message, or Reach Plus Phone. All participants received the same intervention for the first 3 months (weekly calls from peer coach) for MVPA adoption. In Months 4-9, Reach Plus monitored MVPA and received feedback reports. Reach Plus Message monitored MVPA and received weekly text/email messages and feedback reports. Reach Plus Phone participants monitored MVPA and received monthly calls from coaches and feedback reports. Intervention delivery ended at 9 months. Assessments were obtained at baseline, 3, 6, 9, and 12-months. Analyses used a series of longitudinal mixed effects models with subject-specific intercepts. RESULTS: All groups improved significantly across time on psychosocial measures. At 9 months, Reach Plus Message and Reach Plus Phone reported better physical functioning compared to Reach Plus (b = 8.27, 95% CI: [2.27, 14.27]; b = 4.89, 95% CI: [0.01, 10.53]) respectively). At 12 months, Reach Plus Message reported better physical functioning than Reach Plus (b = 4.52, 95% CI: [0.01, 9.75]. Participants who met national PA guidelines reported significantly lower fatigue and higher physical functioning (at 9 and 12 months), and improved mood (at 12 months). CONCLUSIONS: MVPA maintenance via weekly messages or monthly coach calls improved physical functioning. Maintaining MVPA at or above national recommendations was associated with improved physical functioning, mood and less fatigue.

Methodological approach for an integrated female-specific study of anxiety and smoking comorbidity.

Two primary ovarian hormones that fluctuate across the female menstrual cycle-estradiol and progesterone-have been independently linked in separate literatures to nicotine reinforcement and anxiety psychopathology. We identify existing methodological limitations in these literatures, describe an example protocol that was developed to address such limitations, highlight case examples, and offer insights on the resulting advantages and challenges. This protocol was an observational, prospective, within-subjects study of female cigarette smokers who were followed over the course of a complete menstrual cycle. Non-treatment seeking, female cigarette smokers (N = 50), between the ages of 18-40 who have a normal menstrual cycle (25-35 days in length) were recruited from the community. Females with anxiety or mood psychopathology represented 38.0% of the sample. Salivary progesterone and estradiol were assessed each morning via at-home saliva collection methods. Self-reported within-day momentary ratings of anxiety and nicotine reinforcement were collected using ecological momentary assessment (EMA) via a mobile app. Protocol compliance was >85%. Within- and between-subjects heterogeneity was observed in the progesterone and estradiol, anxiety, and nicotine craving measures, especially in the context of anxiety psychopathology. We aimed to integrate the anxiety and nicotine dependence literatures and advance the empirical study of the role of ovarian hormones. This protocol reflects an intensive, yet feasible approach to collecting daily-level naturalistic data related to estradiol, progesterone, anxiety, and nicotine reinforcement.

A randomized trial examining the effect of yoga on dietary lapses and lapse triggers following behavioral weight loss treatment.

Background: Dietary lapses can hinder weight loss and yoga can improve self-regulation, which may protect against lapses. This study examined the effect of yoga on dietary lapses, potential lapse triggers (e.g., affective states, cravings, dietary temptations), and reasons for initiating eating following weight loss treatment. Methods: Sixty women with overweight/obesity (34.3 ± 3.9 kg/m2) were randomized to a 12 week yoga intervention (2x/week; YOGA) or contact-matched control (cooking/nutrition classes; CON) following a 12-week behavioral weight loss program. Participants responded to smartphone surveys (5x/day) over a 10-day period at baseline, 12, and 24 weeks to assess lapses and triggers. Results: At 24 weeks, YOGA and CON differed on several types of lapses (i.e., less eating past full, eating more than usual, loss of control when eating, self-identified overeating, difficulty stopping eating in YOGA), and YOGA was less likely to eat to feel better or in response to stress (ps < 0.05). YOGA also reported less stress and anxiety and more positive affect (ps < 0.01); dietary temptations and cravings did not differ from CON. Conclusion: Yoga resulted in fewer dietary lapses and improved affect among women with overweight/obesity following weight loss. While preliminary, findings suggest that yoga should be considered as a potential component of weight loss treatment to target dietary lapses.

Cost-effectiveness of peer-delivered physical activity promotion and maintenance programs for initially sedentary breast cancer survivors.

The evidence for the survival and health benefits of physical activity (PA) among cancer survivors is well documented. However, it has been challenging to maintain PA among cancer survivors. To evaluate the cost-effectiveness of peer support to encourage maintenance of moderate-to-vigorous physical activity (MVPA) among breast cancer survivors. Participants were randomized into Reach Plus Message (weekly text/email messages), Reach Plus Phone (monthly phone calls) or Reach Plus (a self-monitoring intervention) over 6 months after an initial adoption phase. We calculated the incremental cost-effectiveness ratios (ICER) in terms of quality-adjusted years life years (QALYs) and self-reported MVPA, from the payer's budgetary and societal perspectives over 1 year. Intervention costs were collected via time logs from the trainers and peer coaches, and participant costs from the participants via surveys. For our sensitivity analyses, we bootstrapped costs and effects to construct cost-effectiveness planes and acceptability curves. The intervention that provides weekly messages from peer coaches has an ICER of $14,446 per QALY gained and $0.95 per extra minute of MVPA per day over Reach Plus. Reach Plus Message has a 49.8% and 78.5% probability of cost-effectiveness respectively when decision makers are willing to pay approximately $25,000 per QALY and $10 per additional minute of MVPA. Reach Plus Phone, which requires tailored monthly telephone calls, costs more than Reach Plus Message but yields less QALY and self-reported MVPA at 1 year. Reach Plus Message may be a viable and cost-effective intervention strategy to maintain MVPA among breast cancer survivors.

Sustained physical activity (PA) among cancer survivors can increase survival and decrease the recurrence of cancer. However, it has been challenging to encourage cancer survivors to sustain exercise programs. In this study, we sought to understand whether two types of peer support interventions shown to sustain PA among cancer survivors can do so cost-effectively. Based on our previous study showing that weekly text messages or monthly personalized phone calls can help cancer survivors exercise more and for a longer period of time, we conducted this study to understand which intervention is more cost-effective to implement. We found that text messages are more cost-effective than personalized phone calls, costing $14,446 for every additional quality-adjusted life year gained and $0.95 for every additional minute of moderate-to-vigorous PA per week compared to the comparator group of cancer survivors who only received educational support at the beginning of the study.

Mediators of physical activity maintenance during a 12-month randomized controlled trial among breast Cancer survivors.

PURPOSE: To explore the theoretical constructs that functioned as mediators of interventions for moderate-to-vigorous physical activity (MVPA) maintenance among breast cancer survivors. METHOD: 161 survivors were randomized into 3 groups: Reach Plus, Reach Plus Message or Reach Plus Phone. All participants received a 3-month theory-based intervention delivered by volunteer coaches. During months 4-9, all participants monitored their MVPA and received feedback reports. Additionally, Reach Plus Message received weekly text/email messages and Reach Plus Phone received monthly calls from their coaches. Assessments of weekly MVPA minutes and theoretical constructs (self-efficacy, social support, physical activity [PA] enjoyment and PA barriers) were obtained at baseline, 3, 6, 9 and 12-months. ANALYSES: Using a multiple mediator analysis with a product of coefficients approach, we examined mechanisms associated with between-group differences over time in weekly MVPA minutes. RESULTS: Self-efficacy mediated effects of Reach Plus Message vs. Reach Plus at 6 (ab = 16.99) and 9 M (ab = 27.45); social support mediated effects at 6 (ab = 4.86), 9 (ab = 14.30) and 12 M (ab = 6.18). Self-efficacy mediated effects of Reach Plus Phone vs. Reach Plus at 6 (ab = 18.76), 9 (ab = 28.93) and 12 M (ab = 18.18). Social support mediated effects of Reach Plus Phone vs. Reach Plus Message at 6 (ab=-5.50) and 9 M (ab=-13.20); PA enjoyment mediated effects at 12 M (ab=-3.63). CONCLUSIONS: PA maintenance efforts should focus on strengthening breast cancer survivors' self-efficacy and obtaining social support.The trial was registered at ClinicalTrials.Gov: NCT02694640 (Feb. 26, 2016).

Minor Consent Laws for Sexually Transmitted Infection and Human Immunodeficiency Virus Services in the United States: A Comprehensive, Longitudinal Survey of US State Laws.

Objectives. To assess changes in minor consent laws for sexually transmitted infection (STI) and HIV testing, treatment, and prevention services in all 50 US states and the District of Columbia from 1900 to 2021. Methods. We coded laws into minor consent for (1) health care generally; (2) STI testing, treatment, and prevention; (3) HIV testing, treatment, and prevention; and (4) pre- or postexposure prophylaxis for HIV prevention. We also coded confidentiality protections and required conditions (e.g., threshold clinician judgments). Results. The largest increase in states allowing minors to consent to STI services occurred during the 1960s and 1970s. By 2021, minors could consent independently to STI and HIV testing and treatment in all 50 states plus DC, STI prevention services in 32 jurisdictions, and HIV prevention services in 33 jurisdictions. Confidentiality protections for minors are rare. Prerequisites are common. Conclusions. Although the number of states allowing minors to consent independently to STI and HIV services has increased considerably, these laws have substantial limitations, including high complexity, prerequisites requiring clinician judgments, and neglect of confidentiality concerns. (Am J Public Health. 2023;113(4):397-407. https://doi.org/10.2105/AJPH.2022.307199).

Mediators of physical activity outcomes in a peer-led intervention for breast cancer survivors.

OBJECTIVES: Physical activity (PA) adoption can reduce treatment-related sequelae of breast cancer. Peer-led PA interventions are a promising and relatively inexpensive approach to scaling up interventions. The current study seeks to identify mediators of PA change amongst cancer survivors enrolled in a peer-led behavior change intervention. The study team partnered with the American Cancer Society's Reach to Recovery program (RTR) whose volunteers' provided information and support to breast cancer survivors. METHODS: Participants were 76 survivors (mean age 55.6 years, 1.1 years since diagnosis) who were randomized to PA Plus RTR (12-week PA telephone counseling delivered by RTR volunteers) or contact control. Data was collected on PA (self-reported and objectively measured) and potential mediators (self-efficacy, exercise decisional balance [ratio of the pros/advantages to the cons/disadvantages] and social support) at baseline and 12 weeks. Using a multiple mediation approach with bootstrapped standard errors, we examined mediators of the intervention effect on PA outcomes. RESULTS: Compared to control, PA Plus RTR participants had higher mean self-efficacy, lower decisional balance cons and social support at 12 weeks controlling for baseline. Higher mean self-efficacy was associated with greater minutes of self-reported PA, whereas higher decisional balance pros was associated with higher objectively measured PA at 12 weeks. There were significant indirect effects of self-efficacy on self-reported PA and decisional balance on objectively measured PA. CONCLUSIONS: PA Plus RTR increased self-reported and objectively measured PA by changing theoretical constructs hypothesized to be associated with behavior change. Peers delivering a PA intervention should focus on increasing survivors' self-efficacy for exercise especially in challenging circumstances such as being on vacation, and also help to overcome disadvantages of exercise such as taking time away from family.

Peer mentoring for physical activity adoption and maintenance among breast cancer survivors: moderators of physical activity outcomes.

PURPOSE: We aimed to identify the moderators of maintenance strategies' effects to assist cancer care organizations that offer peer mentoring physical activity programs. METHODS: A total of 161 inactive breast cancer survivors participated in a 12-month study and were randomized to one of three conditions at baseline. American Cancer Society's Reach to Recovery coaches delivered weekly calls to participants for the first 3 months. During Months 4-9, participants self-monitored PA and received feedback (Reach Plus) or additionally received monthly calls from coaches (Reach Plus Phone) or weekly text/email messages (Reach Plus Message). Moderate-to-vigorous PA (MVPA) was assessed using self-report and accelerometry at baseline, 3, 6, 9, and 12 months. We examined baseline demographics, cancer-specific, and social cognitive variables as potential moderators of MVPA. Using Latent Class Models, we identified three participant profiles. The profile was used as a moderator in longitudinal mixed-effects models of MVPA. RESULTS: Profile 1 (44%) were married, White, in preparation, with higher income and higher social support. Profile 2 (41%) were older, office employees, African American, with higher PA self-efficacy. Profile 3 (15%) were diagnosed with stage 1 cancer, in contemplation, with higher MVPA and lower social support. At follow-ups, among those with Profile 1, Reach Plus participants had higher MVPA than other groups (f2 [Formula: see text].10). Among those with Profile 2, Reach Plus Message participants had higher mean MVPA than other groups (f2 [Formula: see text].11). Among those with Profile 3, Reach Plus Phone participants had higher MVPA than other groups, f2 [Formula: see text].11 (all ps < .05). CONCLUSIONS: Organizations can choose PA maintenance strategies that are most effective for survivors with specific profiles. IMPLICATIONS FOR CANCER SURVIVORS: Breast cancer survivors with specific profiles increase PA when receiving certain PA maintenance programs. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02694640 (Feb. 26, 2016).

Acute exercise-induced changes in motivation and behavioral expectation for quitting smoking as predictors of smoking behavior in women.

OBJECTIVE: Temporally static self-reports of motivation and behavioral expectation are established predictors of addictive behavior. However, previous research has not tested intervention effects on within-day changes in motivation/behavioral expectation for smoking cessation as mediators of smoking abstinence. The goals of this study were to test whether aerobic exercise exerts acute pre-postexercise effects on motivation and behavioral expectation and to test the main and interactive effects of change in motivation/behavioral expectation for cessation on subsequent smoking abstinence. METHOD: We conducted secondary analyses of ecological momentary assessment data collected among N = 105 women who participated in a 12-week randomized controlled trial (RCT) examining thrice weekly aerobic exercise (vs. contact control) as an adjunct to cessation treatment. A multilevel, longitudinal mixed-effects model was used to test all pathways simultaneously. RESULTS: Exercise (vs. control) was associated with greater increases in motivation (p = .04), but not behavioral expectation (p > .05), pre-to-postexercise session. Increases in motivation and behavioral expectation were associated with higher odds of abstinence at next session (ps < .05), and for those with larger changes in behavioral expectation, larger changes in motivation were associated with greater odds of abstinence (p = .02). There was also an indirect effect of exercise on abstinence via acute changes in motivation (p < .05). CONCLUSIONS: A single bout of exercise can increase motivation for quitting smoking, which may improve quit success. Moreover, increasing behavioral expectation may enhance the effect of increased motivation on cessation. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Resistance training for Black men with depressive symptoms: a pilot randomized controlled trial to assess acceptability, feasibility, and preliminary efficacy.

BACKGROUND: Depression is under-recognized in Black men, who are less likely to seek or have access to psychiatric treatment. Resistance training (RT; i.e., weight lifting) can improve depressive symptoms and may be more acceptable to Black men, but its effects have not been examined for Black men with depressive symptoms. METHODS: Fifty Black men with depressive symptoms were randomized to either (a) 12 weeks of RT (coupled with Behavioral Activation techniques to promote adherence) or (b) an attention-control group (Health, Wellness, and Education; HWE). Both groups met twice/week for 12 weeks, and follow-up assessments were done at end-of-treatment (EOT) and 6 months after enrollment. Changes in physical activity and muscular strength were collected as a manipulation check. The primary outcome was interviewer assessed symptoms of depression using the Quick Inventory of Depression Symptomology (QIDS). Secondary outcomes included self-reported depressive symptoms, anxiety, and stress. The association between change in QIDS from baseline to EOT and concurrent changes in physical activity and muscular strength in the RT group were explored as an initial assessment of mechanism. Longitudinal mixed effects regression models with subject-specific intercepts were used to examine intervention effects. RESULTS: A sample with high rates of medical comorbidities (e.g., 44% HIV positive), substance use (e.g., 34% smoking), and negative social determinates of health (e.g., 50% unemployed) was enrolled. Recruitment, engagement, and retention data indicate that the intervention and design were feasible. The RT group showed greater gains in self-reported exercise (b = 270.94, SE = 105.69, p = .01) and muscular strength (b = 11.71, SE = 4.23, p = .01 for upper body and b = 4.24, SE = 2.02, p = .04 for lower body) than the HWE group. The RT group had greater reductions in QIDS scores at both EOT (b = -3.00, SE = 1.34, p = .01) and 6 months (b = -2.63, SE = 1.81, p = .04). The RT group showed a greater reduction in anxiety at EOT (b = -2.67, SE = 1.06, p = .02). Findings regarding self-reported depressive symptoms and stress were non-significant, but in the expected direction with effect sizes in the small to medium range. In the RT group, improvement on the QIDS between baseline and EOT was associated with concurrent improvements in physical activity (b = 21.03, SE = 11.16, p = .02) and muscular strength (b = 1.27, SE = .44, p = .03 for upper body and b = .75, SE = .14, p = .03 for lower body). CONCLUSIONS: Results suggest that RT is feasible and may be efficacious for reducing depressive symptoms among underserved urban Black men. TRIAL REGISTRATION: ClinicalTrial.gov #: NCT03107039 (Registered 11/04/2017).

Affective responses to overeating episodes in women participating in a behavioral weight loss program.

BACKGROUND: Much research has focused on precursors to dietary lapses in weight loss programs, but less is known about how individual responses to lapses may influence future non-adherence and program success. The current study examined affective responses to overeating lapses and their influence on subsequent overeating and overall weight loss. METHODS: Women (n = 60) with overweight or obesity (BMI (mean ± SD): 34.3 ± 3.9 kg/m2; age: 48.1 ± 10.1 years) participated in a 3-month group behavioral weight loss intervention (BWLI). At baseline and 3 months, participants completed anthropometric assessments and a 10-day ecological momentary assessment protocol sent 5 times per day reporting on overeating and affect (stress, shame, anxiety, and feeling good about oneself). Across time points, multilevel models were used to examine affective responses to overeating and to predict likelihood of subsequent overeating. Linear regression models were used to examine the effect of affective responses to overeating (at baseline and collapsed across time points) on weight loss. RESULTS: Following self-reported overeating episodes, compared to non-overeating episodes, feeling good about oneself decreased. These decreases lessened with time from overeating. Overeating predicted subsequent overeating episodes, with decreases in feeling good about oneself following overeating marginally predicting increased likelihood (p = 0.065). Neither overeating frequency at baseline nor change in overeating frequency predicted weight loss; however, greater decreases in anxiety following overeating were associated with less weight loss. CONCLUSIONS: Self-reported overeating during a BWLI was associated with negative affective responses and may have increased the likelihood of subsequent overeating, but did not affect overall weight loss in this sample.

Physical Activity Adoption and Maintenance Among Breast Cancer Survivors: A Randomized Trial of Peer Mentoring.

BACKGROUND: Peer support can extend the reach of physical activity (PA) interventions. In previous studies, peer support via weekly counseling calls increased PA at 3 and 6 months among breast cancer survivors, compared to contact control. However, effects were attenuated at 6 months. Interventions targeting PA maintenance among cancer survivors are limited. Hence, we extended prior work to identify effective PA maintenance interventions. PURPOSE: Following a 3-month PA intervention, the study compared the effects of three 6-month interventions on PA at 12 months. METHODS: One hundred and sixty-one inactive breast cancer survivors participated in a 12-month randomized controlled trial. Intervention delivery was uniform for the first 3-months: all participants received a weekly call with their peer coach to encourage PA. Following month 3, participants self-monitored PA and received feedback reports (Reach Plus) or additionally received, a monthly phone call (Reach Plus Phone), or weekly text message (Reach Plus Message). Moderate-to-vigorous PA (MVPA) was measured using self-report (7 Day PAR) and accelerometry at baseline, 3, 6, 9, and 12 months. RESULTS: At 3 months, there were significant within group increases in self-reported and objectively measured MVPA with no between-group differences (ps > .05). At 6 months, adjusted longitudinal models showed that Reach Plus Message reported an additional 23.83 (SD = 6.33, f2 = .12) min/week of MVPA and Reach Plus Phone reported an additional 18.14 min/week (SD = 5.15, f2 =.16) versus Reach Plus. Results were similar at 9 months. At 12 months, Reach Plus Message and Reach Plus Phone both out-performed Reach Plus (ps = .04 and .05 respectively and effect sizes f2 = .11 and f2 = .21 respectively). Accelerometer data showed similar patterns: Reach Plus Message and Reach Plus Phone out-performed Reach Plus at 6 (f2 = .20) and 9 months (f2 = .09). CONCLUSION: Phone calls from peer mentors and text messaging can support PA maintenance among breast cancer survivors. CLINICAL TRIAL INFORMATION: ClinicalTrials.Gov NCT02694640.

Randomized Trial Examining the Effect of a 12-wk Exercise Program on Hedonic Eating.

PURPOSE: This efficacy trial tests the hypothesis that exercise training favorably affects hedonic eating (i.e., overeating, stress-induced overeating, disinhibited eating, eating when tempted), in a sample of women who are overweight or obese. METHODS: Participants were inactive at baseline, self-identified as "stress eaters," and were randomized to 12 wk of moderate-intensity exercise training (EX; combination of supervised and objectively confirmed unsupervised sessions) or to a no-exercise control condition (CON). EX participants were given an exercise goal of 200 min·wk-1. No dietary instructions or weight control strategies were provided. Assessments occurred at baseline and 12 wk. Overeating episodes, stress-induced overeating, and dietary temptations were measured over 14 d at each assessment using ecological momentary assessment. Disinhibition and dietary restraint were assessed via a questionnaire. RESULTS: Forty-nine participants (age, 40.4 ± 10.8 yr; body mass index, 32.4 ± 4.1 kg·m-2) enrolled, and 39 completed this study. Adherence to the exercise intervention was high (99.4% of all prescribed exercise). At week 12, the proportion of eating episodes that were characterized as overeating episodes was lower in EX versus CON (21.98% in EX vs 26.62% in control; P = 0.001). Disinhibition decreased in EX but not in CON (P = 0.02) and was driven by internal factors. There was a trend such that CON was more likely to give into dietary temptations (P = 0.08). Stress-induced overeating was low and did not differ between conditions (P = 0.61). CONCLUSIONS: Exercise training reduced the likelihood of overeating and eating in response to internal cues in women who self-identified as stress eaters. This may be one pathway by which exercise affects body weight.

Chronic care treatment for smoking cessation in patients with serious mental illness: a pilot randomized trial.

BACKGROUND: Rates of smoking among those with serious mental illness (SMI) are two to three times higher than for the general population. Smoking is rarely addressed in mental health settings. Innovative outreach and treatment strategies are needed to address these disparities. The current study is a pilot study of the feasibility and acceptability of a chronic care model of tobacco cessation treatment implemented in outpatient psychiatry clinics. METHODS: Participants were recruited from two outpatient psychiatric clinics and randomly assigned to intervention (counseling and nicotine replacement for 8 weeks, plus ongoing proactive outreach calls inviting reengagement in treatment) or control (brief education and referral to the state quit line). Assessments were conducted at 8 weeks (end of initial treatment block) and 6 months (end of window for retreatment). Feasibility was assessed by enrollment rate, treatment engagement, and completion of follow-up assessments. Acceptability was assessed both quantitatively and qualitatively. Preliminary efficacy was assessed by 7-day and 30-day abstinence rates, rate of quit attempts, and cigarettes per day. Psychological health was measured to assess for changes related to treatment group or attempts to quit smoking. RESULTS: Nineteen participants were randomized to intervention and 19 to control. Recruitment proved feasible, and high rates of treatment engagement (mean of 4.5 sessions completed in initial treatment block, 89.5% uptake of nicotine replacement) and retention (94.7% of follow-up assessments completed) were observed. Treatment acceptability was high. As anticipated, there were no significant differences in abstinence between groups, but results generally favored the intervention group, including bio-verified 7-day abstinence rates of 21.1% in intervention vs. 17.6% in control and self-reported 30-day abstinence rates of 16.1% in intervention vs. 5.1% in control at 8 weeks. Significantly more intervention participants made at least one quit attempt (94.7% vs 52.6%; OR = 16.20, 95% CI: 1.79-147.01). Cigarettes per day decreased significantly more in the intervention group at 8 weeks (b = - 13.19, SE = 4.88, p = .02). CONCLUSIONS: It was feasible to recruit and retain SMI patients in a smoking cessation trial in the context of outpatient psychiatry. The novel chronic care model treatment was acceptable to patients and showed promise for efficacy. If efficacious, a chronic care model could be effective at reducing smoking among SMI patients. TRIAL REGISTRATION: ClinicalTrial.gov #: NCT03822416 (registered January 30th 2019).

The many faces of recruitment in a randomized controlled trial.

BACKGROUND: Thoughtful approaches to study recruitment are a critical step in designing and implementing randomized controlled trials. Delays and challenges in recruitment can be costly and can result in smaller than proposed sample sizes which have downstream effects, such as underpowered studies. PURPOSE: The current study evaluated recruitment methods (e.g., targeted mailings, brochures/flyers, social media) and their relationship to eligibility, randomization, participant characteristics and retention at end of a randomized controlled trial of physical activity adoption and maintenance among breast cancer survivors. METHODS: Screening data from 874 women was analyzed for recruitment method, study eligibility, randomization and retention through end of treatment. Costs per randomized participant were calculated by recruitment method. Baseline participant characteristics were compared across recruitment methods and between randomized and retained participants. RESULTS: Rates of participant accrual from eligibility screening through randomization differed statistically significantly depending on recruitment method (p < .05). The highest randomization rates were obtained via targeted mailings (88.2%) and lowest via brochure/flyer (0.4%). Among the randomized sample, there were no differences in demographic characteristics between recruitment methods, however, there were differences within the targeted mailings category (registries vs. organizational recruitment). There were statistically significant differences in costs between recruitment methods (p < .001) with lowest (non-negligible) cost being targeted mailings. CONCLUSIONS: The current RCT of breast cancer survivors successfully recruited and retained participants, highlighting the need to combine recruitment methods to achieve accrual goals. Recruitment methods differed substantially in their cost and their ability to attract individuals who would ultimately be randomized.

Sedentary behavior among breast cancer survivors: a longitudinal study using ecological momentary assessments.

PURPOSE: Sedentary behavior (SB) or any waking behavior ≤ 1.5 METs is associated with an increase in body weight and fatigue and poor quality of life among cancer survivors. The purpose of this study was to explore longitudinal trends in SB using accelerometers and associated variables via ecological momentary assessments (EMA) among breast cancer survivors. METHODS: Breast cancer survivors (within 5 years post-diagnosis) were recruited for a 12-month observational study. Participants were asked to download an EMA application to their smartphones to receive prompts for 7 days and to concurrently wear an Actigraph accelerometer. Participants responded to 35 prompts during each 7-day assessment period at baseline, and at 3, 6, 9, and 12 months. Within each prompt, participants were asked questions about their current level of affect, sadness, anxiety, stress, worry and fatigue, and cancer-related symptoms (e.g., neuropathy). RESULTS: Twenty-two survivors (mean age = 51.5 years) were recruited and 20 participants completed the study. Mean baseline SB averaged 76.7 h/week. Univariate longitudinal models suggested higher levels of sadness, anxiety, stress, worry, and fatigue were associated with more SB while more positive affect was associated with less SB. Additionally, non-leisure context (work) was associated with more SB. Autoregressive models indicated cross-lagged effects of affective valence, fatigue, and SB. CONCLUSIONS: More negative affective valence and higher fatigue were associated with more SB. Reducing negative affect valence and offering non-sedentary approaches to manage fatigue may help reduce SB. IMPLICATIONS FOR CANCER SURVIVORS: Specific interventions are needed to reduce SB among cancer survivors-particularly those that target negative affect valence and fatigue.

Perceived Pain and Smoking Interrelations and Expectancies Are Associated With Pain and Smoking Cessation in Individuals With Mobility Impairments.

INTRODUCTION: Smoking and pain are highly prevalent among individuals with mobility impairments (MIs; use assistive devices to ambulate). The role of pain-related smoking motives and expectancies in smoking cessation is unknown. We examined cross-sectional and prospective associations between a novel measure of pain-related smoking motives (how smokers with pain perceive their pain and smoking to be interrelated) and pain and smoking behavior in smokers with MI. METHODS: This is a secondary data analysis of a smoking cessation induction trial (N = 263; 55% female) in smokers with MI. Participants did not have to want to quit to enroll. Pain-related smoking motives and expectancies were assessed at baseline with the pain and smoking inventory (PSI) which measures perceived pain and smoking interrelations in three distinct but related domains (smoking to cope with pain, pain as a motivator of smoking and as a barrier to cessation). Other measures included pain occurrence and interference, nicotine dependence, motivation and self-efficacy to quit smoking, and number of cigarettes per day. Biochemically verified smoking abstinence was assessed at 6 months. RESULTS: PSI scores were significantly higher among smokers with chronic pain occurrence compared to occasional and to no occurrence (p < .002) and were associated with greater pain interference (ps < .01) and lower self-efficacy to quit smoking (ps < .01). In prospective analyses adjusted for age, treatment group, and chronic pain, only expectancies of smoking to help cope with pain predicted lower odds of abstinence. CONCLUSIONS: Targeting expectancies of smoking as a mechanism to cope with pain may be useful in increasing smoking cessation in pain populations. IMPLICATIONS: Individuals with MI have a high prevalence of smoking and pain, yet the extent to which this population perceives pain and smoking to be interrelated is unknown. This is the first article to examine prospective associations between a novel measure of perceived pain and smoking interrelations (PSI) and smoking outcomes. The PSI was associated with greater pain and lower self-efficacy for quitting. Prospectively, the PSI subscale tapping into expectancies that smoking help coping with pain predicted a lower probability of smoking abstinence. In smokers with MI, expectancies of smoking as pain-coping mechanism may be an important clinical target.

Mediators of physical activity adoption and maintenance among breast cancer survivors.

The purpose of this study is to explore the mediators associated with physical activity (PA) within the adoption and maintenance phase of a PA intervention trial among breast cancer survivors. Overall, 192 breast cancer survivors (average age = 55.9 years) were randomized to an Intervention or Control group. Both groups received 8 calls in the first 3-months, 3 monthly calls, and then entered a no-contact maintenance phase for the remaining 6-months. Assessments were completed at baseline, 3-months, 6-months and 12-months. On average, participants were 55.9 years of age (SD = 9.8) and 2.9 years since diagnosis (SD = 2.2). In the adoption phase, all significant univariate mediators (self-efficacy, cognitive and behavioral processes and decisional balance cons) were included in the multivariate model. Results suggest self-efficacy (ab = 13.56, SE = 7.04) and behavioral processes (ab = 36.10, SE = 12.22) were significant for PA adoption. No mediators were identified in the maintenance phase. In the adoption phase, there were significant indirect effects of group on PA adoption through self-efficacy and behavioral processes. There were no indirect effects of group on PA maintenance.

Association of Body Esteem with Fitness and Body Fat Among Colorectal Cancer Survivors: Secondary Analyses from a Randomized Trial.

BACKGROUND: Survival rates among cancer survivors have improved; however, treatments affect body esteem. Body esteem can significantly affect quality of life and depression following cancer treatment. The purpose of these secondary analyses was to examine the relationship between changes in fitness and body fat with changes in body esteem among colorectal cancer survivors who participated in a randomized controlled trial that tested the effects of a 12-week physical activity intervention. METHOD: Male and female colorectal cancer survivors (< 5 years since diagnosis) participated in a randomized controlled trial that tested a 12-week moderate-intensity physical activity intervention. Body esteem, fitness (estimated VO2 peak), and body composition (bioelectrical impedance) were assessed at baseline and follow-up visits (3 months, 6 months, and 12 months). RESULTS: Forty-six colorectal cancer survivors (57 years old, 57% female) completed the study. Improvements in fitness were associated with improvements in body esteem among males at 6-month and 12-month follow-up visits, while improvements in body fat were associated with increased body esteem at 12-month follow-up among females. Improvements in fitness and body fat among stage 0-2 survivors were associated with significant improvements in body esteem, with no significant changes among stage 3 survivors. CONCLUSION: Results from this study showed that improved fitness and body composition can improve body esteem among these survivors; however, differences exist among gender and disease stage. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT00230646?term=Pinto&cond=Colorectal+Cancer&rank=2.