Attention Control Group Research Articles

Detailed statistical analysis plan for a guided self-determination intervention versus an attention control for outpatients with type 2 diabetes in the randomised OVERCOME trial

BackgroundAutonomy-supporting interventions may be a prerequisite to achieve better long-term management of type 2 diabetes. Evidence suggests that the guided self-determination (GSD) method might improve haemoglobin A1c and diabetes distress in people with type 1 diabetes. The evidence of an effect of a GSD intervention compared with an attention control group in adults with type 2 diabetes is unknown.Methods/designThe trial is designed as a pragmatic, investigator-initiated, dual-centre, randomised, parallel-group, assessor-blinded, superiority clinical trial of persons with type 2 diabetes. A nurse will administer GSD intervention versus an attention control. The primary outcome is diabetes distress, and secondary outcomes are quality of life, depressive symptoms, and non-serious adverse events. Exploratory outcomes are haemoglobin A1c, motivation, and serious adverse events. Participants are assessed at baseline, 5-, and 12-month follow-up. Here, we present a detailed, comprehensive plan of all statistical analyses, including methods to handle missing data, and assessments of the underlying statistical assumptions. The statistical analyses will be conducted independently by two statisticians following the present plan.DiscussionTo mitigate the risk of analysis bias and increase the validity of the OVEROME trial, this statistical analysis plan was developed prior to unblinding of the trial results in concordance with the Declaration of Helsinki and the Conference on Harmonization of Good Clinical Practice Guidelines.Trial registrationClinicalTrials.gov NCT 04601311. Registered on October 2020.

Protocol for a randomized controlled trial to evaluate the effectiveness of a telehealth group intervention to reduce perinatal depressive symptoms

BackgroundPerinatal depression and anxiety (PDA) affect approximately 20 % of individuals and are associated with adverse outcomes, including preterm birth, low birth weight, and impaired cognitive development of the child. Telehealth may reduce access barriers to needed mental health services. However, lack of disseminated, standardized study protocols aimed at investigating the role of telehealth in reducing PDA symptoms limits the ability to compare findings across studies. The purpose of this paper is to provide a conceptual framework and a randomized controlled trial protocol (RCT) for use in future studies. Methods and analysisAn RCT was designed to evaluate the effectiveness of a group videoconference intervention (VCI) to reduce PDA symptoms across pregnancy and postpartum period. Participants are randomly assigned to study groups: VCI + standard of care, or attention control (AC) + standard of care. Both groups have weekly one-hour group videoconference sessions for 9 weeks. The VCI groups are facilitated by a mental health professional using a manualized program based on mindfulness-based practices and cognitive behavioral therapy (MBCT). The AC groups are facilitated by a registered nurse using a manualized program for childbirth and parenting education. The primary outcomes are depressive symptoms as measured by the Edinburgh Postnatal Depression Scale (EPDS) and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7). ConclusionThis RCT study protocol can be used as a standard approach to improve the ability to compare findings across studies, applied in any setting (e.g., rural or urban), and adapted to diverse communities.Trial Registration:ClinicalTrials.govNCT03932760

Safe Use of Screen Time Among Adolescents: A Randomized Controlled Study of the Efficacy of Yoga.

For students between the ages of 11 and 18, the estimated daily exposure to electronic media is around 1.5 hours, suggesting a growing trend in the amount of time spent in front of a screen. Increasing screen time use is related to sleep, mental health, cognitive, emotional, and behavioral disorders, unhealthy diets, depressive symptoms, poor quality of life, and substance-behavioral addictions. The current study is a parallel-group, simple randomized controlledtrial (RCT). A total of 100 participants were randomized into a yoga group (YG) (n=50) and an attentional control group (CG) (n=50) by using an online randomizer. The YG received yoga practice, whereas the partially active CG received an educational program on digital hygiene. Students were assessed for screen time use, Smartphone Addiction Scale-Short Version (SAS-SV), general well-being, depressive symptoms, and generalized anxiety following 12 weeks of intervention. The yoga group showed a significant decrease in the scores of SAS-SV, generalized anxiety, depressive symptoms, and screen time use after the intervention (p<0.001, p<0.05, p<0.01, and p<0.001, respectively). Furthermore, there was a statistically significant decrease in screen time use for all modes of total weekdays, weeknights, and weekends. Additionally, in the yoga group, the majority of the sub-factors of screen time use showed statistically significant changes; time spent on television showed a constant decrease in all modes such as weekdays, weeknights, and weekends. The result of the current study suggests that yoga practice hasa positive influence on screen usage behavior and associated health-related complications. More studies are required to understand if yoga practice can help mitigate the pleasure-seeking behavior that drives the excessive usage of screens.

Effects of aerobic training on cardiopulmonary fitness in patients with long COVID-19: a randomized controlled trial

BackgroundLong COVID-19 is characterized by systemic deterioration of the entire body, leading to significant physical and mental disorders. Exercise training has the potential to improve persistent symptoms and cardiopulmonary functions.MethodThis was a single-center, randomized, controlled trial. Twenty-four patients aged 18 to 75 years who had a history of SARS-CoV-2 infection and long COVID symptoms. Patients were randomly allocated in a 1:1 ratio to receive either a 4-week exercise training program or an attention control group. The training group participated in 12 supervised aerobic sessions on a cycling ergometer over 4 weeks. The outcomes were to assess the impact of a 4-week aerobic exercise on the persistent symptoms and cardiopulmonary fitness, the surrogate endpoints of COVID-19 recovery and cardiopulmonary health.ResultsAfter the 4-week intervention, significant reductions were observed in the total number of symptoms in the training group. Specifically, 67.8% of patients in the training group exhibited reduced or completely resolved symptoms, in comparison to 16.7% in the control group (P = 0.013). After adjusting for gender, significant improvements in the training group were observed for exercise time (Pgroup*time = 0.028), maximum load (Pgroup*time = 0.01), and peak VO2 (Pgroup*time = 0.001), as well as O2 pulse (Pgroup*time = 0.042) and maximum heart rate (Pgroup*time = 0.007). The score of Short Form-12, depression, anxiety, perceived stress, and insomnia did not show significant changes between groups (Pgroup*time > 0.05).ConclusionA supervised aerobic training program has the potential to alleviate persistent symptoms and improve exercise tolerance in patients with long COVID-19. Further research is necessary to confirm these effects in a large population. This intervention could be easily implemented in non-hospital settings, potentially benefiting a broader range of individuals.Trial registration numberClinicalTrials.gov NCT05961462. Registered on July 25, 2023.

Development and testing of a videogame intervention for symptom management among 8–18 years old children with cancer: a study protocol

IntroductionEvidence shows that cancer treatment-related symptoms could be managed effectively in 8–18 years old children through Digital Health Interventions (DHIs), consequently improving their health-related quality of life (HRQOL). However, limited...

Physical activity and symmetry following total knee arthroplasty: Results of a pilot randomized trial

ObjectiveThis pilot trial examined a Physical Activity and Symmetry (PAS) intervention focused on common deficits of physical inactivity and joint loading asymmetry following total knee arthroplasty (TKA). DesignParticipants (n ​= ​60) were enrolled during routine physical therapy (PT) following TKA and randomized to the PAS intervention or an attention (ATT) control group. The PAS intervention included physical activity counseling and balance exercise to address joint loading symmetry; content was delivered during 2 sessions at the end of routine PT plus supplemental sessions 4-weeks and 8-weeks following PT. The ATT control condition included supplemental sessions at 4-weeks and 8-weeks focused on general evaluation of surgical recovery benchmarks. Primary outcomes were weekly minutes of moderate to vigorous physical activity (MVPA), measured with an accelerometer, and peak force loading symmetry (limb symmetry index; LSI) during a 10 ​m walk, measured with a 3-sensor in-shoe device. General linear mixed models compared changes in outcomes between randomized groups at 3-month and 6-month follow-up. ResultsBoth PAS and ATT groups increased MVPA, but there were no clinically meaningful between-group differences at 3- or 6-month follow-up (p ​> ​0.05). There were also no clinically meaningful between-group differences LSI at 3- or 6-month follow-up (p ​> ​0.05). ConclusionThe PAS intervention did not yield improvements beyond ATT control. It is possible that PAS components were being delivered as part of routine PT, and a more intensive intervention (e.g., more visits, guidance for exercise progression) or targeted approach (e.g., those with deficits at end of routine care) may be needed to further improve outcomes.

Multicentre Randomized Controlled Trial of a Nurse-Led Sexual Rehabilitation Intervention to Rebuild Sexuality and Intimacy After Treatment for Gynecological Cancer.

To evaluate the effectiveness of a sexual rehabilitation program, SEXHAB, in improving sexual functioning, reducing sexual distress, and enhancing marital satisfaction for women after gynecological cancer treatment. This is a randomized controlled trial that included 150 women newly diagnosed with gynecological cancer from three public hospitals in Hong Kong. Participants were randomly assigned to the intervention group (n=78) to receive the SEXHAB or to an attention control group (n=72) to receive attention. The SEXHAB comprises four individual- or couple-based sessions with three major components: information provision, cognitive-behavioral therapy and counseling using motivational interviewing skills. The outcomes were measured at baseline (T0), upon completion of the program (T1) and 12-month post-treatment (T2). Semi-structured interviews were also conducted with the SEXHAB group participants to explore their experiences with and opinions toward the program. At both follow-ups, there were no statistically significant differences between groups in improving sexual functioning, sexual distress and marital satisfaction. Nevertheless, participants in the SEXHAB group reported their partners having significantly greater sexual interest at T1 (76% vs. 52%, rate ratio: 1.46, 95% CI: 1.07 to 1.99, p=0.024) and T2 (74% vs. 48%, rate ratio: 1.55, 95% CI: 1.11 to 2.10, p=0.014). From the qualitative interviews, the interviewees who resumed sexual activity reported positive experiences in rebuilding sexuality and intimacy. Despite the quantitative results are negative, the qualitative findings suggest potential benefits of the SEXHAB for women resuming sexual activities after treatment for gynecological cancer. Further studies with longer intervention period and follow-ups are needed to confirm the intervention effects.

Mindfulness-based therapy for insomnia in Black women: a pilot randomized controlled trial.

The purpose of the study was to evaluate the feasibility, acceptability, and preliminary efficacy of mindfulness-based therapy for insomnia (MBT-I) among Black women. The MBT-I group received weekly sessions that included mindfulness meditation and behavioral sleep strategies. The time and attention control group received lifestyle health education (HE) that included healthy eating, physical activity, and sleep hygiene. The primary outcome was post-intervention changes in insomnia severity score by the Insomnia Severity Index (ISI) at week 10. Other measures included: Pittsburgh Sleep Quality Index, Sleep Hygiene Practice, Spielberger State-Trait Anxiety Inventory (STAI), and Patient Health Questionnaire-9 (PHQ-9). Objective sleep was measured by Actiwatch™ at baseline and week 10. Thirty Black women completed the interventions with no attrition. About 97% of all participants attended 6-8 out of 8 sessions. The ISI scores were reduced at week 10 (MBT-I vs. HE: -7.67 vs. -7.22, p < .05). Anxiety and depression symptoms were significantly improved only in the MBT-I group. This is the first MBT-I for Black women with insomnia. Online MBT-I may be feasible and acceptable for Black women. The MBT-I and HE showed a clinically significant improvement in insomnia symptoms (ISI reduction > 7). MBT-I may be more effective in improving anxiety and depression symptoms than HE. Our findings encourage further study efforts with a longer follow-up and larger sample size to address sleep health disparities among Black women.

Testing home-based exercise strategies in underserved minority cancer patients undergoing chemotherapy (THRIVE) trial: a study protocol.

Higher rates of physical inactivity and comorbid conditions are reported in Hispanic/Latinx and Black cancer patients receiving chemotherapy compared to their White counterparts. Despite the beneficial effect of exercise training for cancer patients, rates of participation in exercise oncology clinical trials are low among disadvantaged and racial and ethnic minority groups. Here, we will examine the effect of an exercise intervention using a novel, accessible, and cost-effective home-based exercise approach among Hispanic/Latinx and Black cancer patients receiving chemotherapy on exercise participation and cardiovascular disease risk. The THRIVE trial is an 8-month prospective, three-arm study of 45 patients who are randomized in a 1:1:1 fashion to a supervised exercise intervention (SUP), unsupervised exercise (UNSUP), or an attention control (AC) group. Eligible patients include those with breast, colorectal, or prostate cancer, who are sedentary, overweight or obese, self-identify as Hispanic/Latinx or Black, and plan to receive chemotherapy. Patients randomized to the SUP group participate in a home-based 16-week periodized aerobic and resistance exercise program performed three days per week, supervised through video conference technology. Patients randomized to the UNSUP group participate in an unsupervised 16-week, telehealth-based, periodized aerobic and resistance exercise program performed three days per week using the same exercise prescription parameters as the SUP group. Patients randomized to the AC group receive a 16-week home-based stretching program. The primary outcome is changes in minutes of physical activity assessed by 7-day accelerometry at post-intervention. Secondary outcomes include cardiovascular risk factors, patient-reported outcomes, and physical function. Outcome measures are tested at baseline, post-intervention at month 4, and after a non-intervention follow-up period at month 8. The THRIVE trial is the first study to employ a novel and potentially achievable exercise intervention for a minority population receiving chemotherapy. In addition, this study utilizes an intervention approach to investigate the biological and behavioral mechanisms underlying exercise participation in these cancer patients. Results will guide and inform large randomized controlled trials to test the effect of home-based exercise on treatment outcomes and comorbid disease risk in minority patients with cancer undergoing chemotherapy. https://classic.clinicaltrials.gov/ct2/show/NCT05327452, identifier (NCT#05327452).

A randomized controlled trial of a self-led, virtual reality-based cognitive behavioral therapy on sick role adaptation in colorectal cancer patients: study protocol

BackgroundSignificant concomitants of the sick role maladaptation in colorectal cancer (CRC) patients include inappropriate cognitions, emotional states, and overt conducts associated to disease. This protocol was developed to implement and evaluate the effects of a self-led, virtual reality-based cognitive behavioral therapy (VR-CBT) on the sick role adaptation among working-age CRC patients.MethodsThis is an assessor-blinded, randomized controlled trail that adheres to the SPIRIT 2013 Statement guidelines. A total of 60 working-age CRC patients will be recruited from the colorectal wards of a cancer center and randomly assigned to the VR-CBT group or attention control (AC) group. The VR-CBT group will receive a 7-sessions VR-CBT targeted to sick role adaptation, while the AC group will receive weekly attention at the same time the VR-CBT group receives the intervention. The sick role adaptation, anxiety and depression, illness perceptions, and quality of life will be measured at baseline, 1, 2 and 3-month after completion of the intervention. Side-effects related to VR in the VR-CBT group will be measured at the end of each session. The participants will receive invitations to participate in semi-structured interviews to explore their experiences with the intervention.DiscussionThe positive outcomes and user experience of VR-CBT will advance researches on the effectiveness of psychosocial interventions that aims to promote adaptation to the unexpected sick role on cancer populations. This protocol can be tested as an accessible and feasible alternative to traditional high-cost treatment in a randomized controlled study to improve the outcomes of younger cancer survivors.Trial registration.The protocol was registered on 21 June, 2023 in Chinese Clinical Trial Registry (No.: ChiCTR2300072699) at https://www.chictr.org.cn/.

In-person psychoeducational intervention to reduce rehospitalizations and improve the clinical course of major depressive disorder: a non-randomized pilot study.

Emerging issues in the management of major depressive disorder (MDD) comprise a nonadherence to treatment and treatment failures, depressive recurrence and relapses, misidentification of incoming exacerbated phases and consequently, a chronification of depression. While antidepressant drugs constitute the standard of care for MDD, effective psychosocial interventions are needed to reduce rehospitalizations and other adverse events. The present study primarily investigated the effects and impact of implementing a structured psychoeducational intervention on the clinical course of MDD. A non-randomized comparative, pragmatic, pilot, single-center study of adults with nonpsychotic moderate or severe episode of MDD recently discharged from a psychiatric hospitalization. The consecutive subjects were allocated either to the intervention group (N=49) or to the attention control group (N=47), based on their preference. The psychoeducational intervention was based on a modified Munoz's Depression Prevention Course. Subjects were followed up prospectively for two years. The absolute changes in Beck anxiety inventory scale, Zung's depression questionnaire, and Montgomery and Äsberg depression rating scale (MADRS) total scores at 6-month follow-up were comparable between the two groups. There were lower rates of the rehospitalization within one year (2.1% vs. 16.7%; P<0.001) and less rehospitalizations after one year (6.3% vs. 25%; P<0.001), lower rates of the ongoing sickness absence (11.5% vs. 29.2%; P<0.001), less persons with disability due to MDD at 1-year follow-up (1% vs. 11.5%; P=0.002), and less nonadherent subjects who self-discontinued treatment (6.3% vs. 28.1%; P<0.001) among participants in the intervention group compared to the control group. The disability due to MDD at 1-year follow-up was predicted by the absence of the psychoeducational intervention (P=0.002) and by the MADRS total score at 6-month follow-up (OR 1.10; 95% CI 1.003-1.195; P=0.044). Qualitative data indicated the intervention was desired and appreciated by the participants, as well as being practical to implement in Slovakian clinical settings. The results suggest the psychoeducational intervention based on a modified Munoz's Depression Prevention Course has beneficial effects in adults with MDD recently discharged from a psychiatric hospitalization. The findings implicate the psychoeducational intervention may offer a new approach to the prevention of depressive relapses.

Impact of a Multi-Component Physical Activity Intervention on Psychological Well-Being in Older Adults: A Pilot Study

While the positive effects of physical activity (PA) on mental health are well documented, limited research has explored its influence on the positive psychological well-being in elderly individuals. This study examined the effects of a multi-component PA intervention on various facets of psychological well-being among older adults residing in retirement homes. Fifty-eight elderly individuals (mean age = 83.8 years, 76.3% female) residing in retirement homes participated either in either a 12 week multi-component PA intervention program or in an attention control group. Those in the intervention group engaged in supervised group exercise lessons for 45 min, three times per week, and used wearable activity monitors during weekdays over 12 weeks. Assessments were conducted before and after the intervention to measure happiness, life satisfaction, eudaimonic well-being, and depressive symptoms, which are four components of psychological well-being. On average, those in the intervention group attended about 86.9% of group exercise sessions and used the activity trackers for 97.5% of the designated days. Results from linear mixed models indicated that the intervention had a positive effect on happiness in the intervention group, but not in the control group. Nonetheless, no significant differences were found in terms of changes in eudaimonic well-being, life satisfaction, and depressive symptoms between the two groups. This selective impact on different dimensions of psychological well-being implies that subsequent research could explore the integration of more comprehensive components in PA interventions targeting all dimensions of psychological well-being, as each of them is a key aspect of healthy aging and independently related to a range of health outcomes amongst older adults.

Project phoenix: Pilot randomized controlled trial of a smartphone-delivered intervention for people who are not ready to quit smoking

BackgroundMost people who smoke cigarettes report they want to quit in the future, but only 20 % are ready to quit within the next 30 days. This 3-arm pilot randomized controlled trial examined the feasibility and initial efficacy of a novel smartphone-based intervention that aimed to induce smoking cessation attempts among adults not initially ready to quit. MethodsParticipants randomized into the two intervention groups (Group 1: Phoenix App Only; Group 2: Phoenix App + Nicotine Replacement Therapy) received daily smoking cessation messages via smartphone application that were tailored to their current readiness to quit, while the attention control group (i.e., Factoid) received messages not related to smoking cessation. All participants completed a weekly survey for 26 weeks and used the app to set quit dates when/if desired. ResultsParticipants (N=152) were female (67.8 %), White (75.7 %), 50.0 years old (SD=12.5), and smoked 20.4 cigarettes per day (SD=10.5). Results indicated that the Phoenix interventions were feasible (e.g., participants viewed ~185 messages over 26 weeks; 74.8 % of weekly surveys were completed; 85.5 % completed the 26-week follow-up assessment). Phoenix participants set more quit dates, set quit dates sooner, were abstinent for more days, and used smoking cessation medications on more days than those assigned to the Factoid group. ConclusionsThis low-burden, smartphone-based smoking cessation induction intervention may increase smoking cessation attempts, and may reduce barriers that are encountered with traditional in-person or call-based interventions.Trial Registration: Clinicaltrials.gov number: NCT03405129; https://clinicaltrials.gov/ct2/show/NCT03405129

Technology-based interactive communication simulation addressing challenging communication situations for nursing students

BackgroundSimulation-based interventions for nursing students addressing challenging communication situations involving geriatric patients and end-of-life care are limited. PurposeThis study evaluated the effects of technology-based interactive communication simulations on nursing students' communication knowledge, self-efficacy, skills, compassion, and program satisfaction. MethodA randomized controlled repeated-measures design was used with third- and fourth-year nursing students enrolled in five nursing colleges located in five regions in Korea as participants. Participants were randomly assigned to either a technology-based interactive communication simulation or an attention control group. Changes in communication knowledge, self-efficacy, skills, compassion, and program satisfaction were assessed using three self-reported measures and communication skills were measured by the raters. Statistical analyses included descriptive analyses, chi-square tests, t-tests, and a generalized estimating equation model. ResultsEighty students participated in one of the two programs, and 77 in the four-week follow-up test. The intervention group indicated significant improvements in communication knowledge, self-efficacy, skills, and compassion, as well as higher program satisfaction compared with the attention control group. Communication skills as assessed by raters also showed significant change at all assessment time points. ConclusionThe technology-based interactive communication simulation program is effective in improving communication skills among nursing students managing geriatric patients and end-of-life care.

Abstract PO4-11-09: Feasibility of physical activity behaviour change for women living with metastatic breast cancer, a randomised controlled trial

Abstract Background Physical activity benefits women living with metastatic breast cancer by improving outcomes such as physical function, health-related quality of life and fatigue. These findings have been reported within well-resourced trials that involve exercise equipment and supervision. Home or community-based settings, however, may be preferable and more accessible. This trial evaluated the feasibility of a remotely delivered behaviour change intervention for increasing physical activity for women living with metastatic breast cancer, and evaluated the program’s efficacy. Methods A 12-week randomised controlled trial was conducted in which 20 women living with metastatic breast cancer were recruited from a metropolitan outpatient cancer clinic. Inclusion criteria were over 18 years old, English speaking, ambulatory, and not regularly active at time of recruitment. Participants were randomised 1:1 to an intervention or attention control group. Both groups received a recommendation for 150 minutes of physical activity, a wrist-worn activity monitor, a physical activity diary, and nine phone or video call sessions (six weekly, three fortnightly). The intervention group received individualised behaviour change advice on topics such as physical activity benefits, motivation, barriers and social support; the attention control group received a recurring symptom questionnaire and no behavioural advice. Feasibility outcomes included recruitment, dropout and session adherence rates, and acceptability of methods was evaluated with an interview at trial completion. Baseline and 12-week outcomes included: i) physical activity minutes measured with a 5-day Actigraph wear, ii) 6-minute walk distance, iii) 30-second sit-to-stands, iv) questionnaires for self-reported physical activity, health-related quality of life, fatigue, behavioural factors (stage of change, self-efficacy, decisional balance, processes of change, social support), and patient-specific function. Questionnaires were measured again at 18 weeks. Results Recruitment, baseline measures and within-trial sessions are completed; 12 and 18-week measures will conclude late August. Thirty-two women were approached to enrol the target sample of 20, with exclusion reasons being disinterest (n=5), health problems (n=4), loss of contact (n=2) and already physically active (n=1). Median age was 62 years (IQR: 60-69), and median time since metastatic diagnosis was 4 years (IQR: 1-5). Twelve women had bone metastases, and ten had a musculoskeletal comorbidity. Session delivery through video or phone calls were equally preferred (n=10 each). Participants completed 84% of the sessions, with reasons for missed sessions consisting of forgetting (55%), feeling unwell (24%), IT problems (7%), holiday (7%), and work commitments (7%). Median session duration for the intervention group was 23 minutes (IQR: 20-28), and control group was 17 minutes (IQR: 14-21). The preferred type of physical activity was predominantly walking, and no adverse events were reported. Four women dropped out after loss of contact. Compared to age-matched normative values, baseline outcomes varied: actigraphy-measured physical activity was low (median: 68 minutes/day, IQR: 45-88), self-reported physical activity was high (median: 289 MET-minutes/day, IQR: 52-728), 6-minute walk distance was equal (median: 529m, IQR: 416-579), 30-second sit-to-stands were low (median: 11, IQR: 8-14), health-related quality of life was high (median: 80, IQR: 70-100), and fatigue was equal (median: 30, IQR 20-40). Conclusions Women living with metastatic breast cancer were generally receptive of the trial, and recruitment, dropout and session adherence rates were positive. The women who dropped out were more physically active, physically functional and/or rated higher on the questionnaires, indicating that the trial may be more suited to those with limited physical activity experience. Citation Format: Mark Liu, Sharon Kilbreath, Elizabeth Dylke, Jasmine Yee, Jane Beith. Feasibility of physical activity behaviour change for women living with metastatic breast cancer, a randomised controlled trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-11-09.

Equine-assisted service’s effect on cartilage and skeletal biomarkers for adults and older adults with arthritis: A pilot study

ObjectiveThe object of this study was to determine the effect of EAS (Equine-Assisted Services) on arthritis conditions, as measured by the sTnT (Skeletal troponin) and COMP (cartilage oligomeric matrix proteins) biomarkers, compared to an exercise attention control intervention. DesignThis was a secondary analysis of a randomized clinical trial comparing equine-assisted therapy to exercise education attention-control on cartilage and skeletal biomarkers in adults with arthritis. Twenty-one adults (Mage = 64 years) with arthritis who attended rheumatology clinics in the midwestern United States participated. ResultsNo changes were found in sTnT from baseline to week six within either intervention nor were there differences in changes between the two groups (p = 0.91). COMP increased from baseline to week six for both conditions, suggesting increased deterioration of cartilage and joints. Although the attention-control condition demonstrated larger increases in cartilage oligomeric matrix proteins level, compared to the EAS condition, these differences were not statistically (p = 0.58) or clinically significant (i.e., trivial effect, d = −0.16). When 3 outliers were removed, the differences in changes between EAT and attention-control group could be arguably of clinical significance (d = - 0.33), suggesting that the attention-control group demonstrated larger increases in levels of COMP than those in the EAS condition, though this difference was not statistically significant (p = 0.28). ConclusionAlthough equine-assisted therapy may reduce pain and improve quality of life for adults with arthritis, findings here are not fully corroborated with biomarkers.

Attentional Bias Toward Cigarette-Related Cues in Male Smokers is Modulated by Cognitive Control Mechanisms

Background: Many studies have found that smokers’ attentional bias toward cigarette-related cues and cognitive control impairment significantly impacts their cigarette use. However, there is limited research on how the interaction between attentional bias and cognitive control may modulate smokers’ cigarette-seeking behavior. Objectives: This study used a cigarette Stroop task to examine whether smokers with different attentional control ability had different levels of attentional bias toward cigarette-related cues. Methods: A total of 130 male smokers completed the Flanker task to measure their attentional control ability. The attentional control scores of all participants were ranked from low to high, with the top 27% placed in the high attentional control group and the bottom 27% in the low attentional control group. Subsequently, both groups completed the cigarette Stroop task to measure their attentional bias toward cigarette-related cues. Results: Smokers with low attentional control responded more slowly to cigarette-related cues than to neutral cues, while smokers with high attentional control showed no significant difference in their response time to either condition. Conclusions/Importance: Attentional control ability can regulate smokers’ attentional bias toward cigarette-related cues. Smokers with low attentional control ability are more likely to have attentional bias toward cigarette-related cues, offering insights for targeted prevention of cigarette addiction.

Sitting Time Reduction and Blood Pressure in Older Adults

Practical health promotion strategies for improving cardiometabolic health in older adults are needed. To examine the efficacy of a sedentary behavior reduction intervention for reducing sitting time and improving blood pressure in older adults. This parallel-group randomized clinical trial was conducted in adults aged 60 to 89 years with high sitting time and body mass index of 30 to 50 from January 1, 2019, to November 31, 2022, at a health care system in Washington State. Participants were randomized 1:1 to the sitting reduction intervention or a healthy living attention control condition for 6 months. Intervention participants received 10 health coaching contacts, sitting reduction goals, and a standing desk and fitness tracker to prompt sitting breaks. The attention control group received 10 health coaching contacts to set general healthy living goals, excluding physical activity or sedentary behavior. The primary outcome, measured at baseline, 3 months, and 6 months, was sitting time assessed using accelerometers worn for 7 days at each time point. Coprimary outcomes were systolic and diastolic blood pressure measured at baseline and 6 months. A total of 283 participants (140 intervention and 143 control) were randomized (baseline mean [SD] age, 68.8 [6.2] years; 186 [65.7%] female; mean [SD] body mass index, 34.9 [4.7]). At baseline, 147 (51.9%) had a hypertension diagnosis and 97 (69.3%) took at least 1 antihypertensive medication. Sitting time was reduced, favoring the intervention arm, with a difference in the mean change of -31.44 min/d at 3 months (95% CI, -48.69 to -14.19 min/d; P < .001) and -31.85 min/d at 6 months (95% CI, -52.91 to -10.79 min/d; P = .003). Systolic blood pressure change was lower by 3.48 mm Hg, favoring the intervention arm at 6 months (95% CI, -6.68 to -0.28 mm Hg; P = .03). There were 6 serious adverse events in each arm and none were study related. In this study of a 6-month sitting reduction intervention, older adults in the intervention reduced sedentary time by more than 30 min/d and reduced systolic blood pressure. Sitting reduction could be a promising approach to improve health in older adults. ClinicalTrials.gov Identifier: NCT03739762.

Effect of Intrapersonal and Interpersonal Behavior Change Strategies on Physical Activity Among Older Adults

Despite guidelines that recommend physical activity (PA), little is known about which types of behavior change strategies (BCSs) effectively promote sustained increases in PA in older adults who are insufficiently active. To determine whether intrapersonal BCSs (eg, goal setting) or interpersonal BCSs (eg, peer-to-peer sharing or learning) combined with the Otago Exercise Program (17 strength and balance exercises and a walking program that are learned and individually tailored, with instruction to perform 3 times per week at home or location of choice) and a wearable PA monitor help older adults sustain increases in their PA. This 2 × 2 factorial randomized clinical trial (Community-Based Intervention Effects on Older Adults' Physical Activity) of community-dwelling older adults 70 years or older with PA levels below minimum national PA guidelines was conducted in urban community centers. Dates of enrollment were from November 17, 2017, to June 15, 2021, with final follow-up assessments completed on September 2, 2022. Participants were randomized to intrapersonal (eg, goal setting) BCSs, interpersonal (eg, problem-solving with peer-to-peer sharing and learning) BCSs, intrapersonal and interpersonal BCSs, or an attention control group. All interventions included a PA monitor and 8 weekly small-group meetings with discussion, practice, and instructions to implement the exercise program and relevant BCSs independently between meetings and after the intervention. The primary outcome was daily minutes of objectively measured total PA (light, moderate, or vigorous intensities) averaged over 7 to 10 days, measured at baseline and after the intervention at 1 week, 6 months, and 12 months. Among 309 participants (mean [SD] age, 77.4 [5.0] years; 240 women [77.7%]), 305 (98.7%) completed the intervention, and 302 (97.7%) had complete data. Participants receiving PA interventions with interpersonal BCS components exhibited greater increases in total PA than did those who did not at 1 week (204 vs 177 PA minutes per day; adjusted difference, 27.1 [95% CI, 17.2-37.0]; P < .001), 6 months (195 vs 175 PA minutes per day; adjusted difference, 20.8 [95% CI, 10.0-31.6]; P < .001), and 12 months (195 vs 168 PA minutes per day; adjusted difference, 27.5 [95% CI, 16.2-38.8]; P < .001) after the intervention. Compared with participants who did not receive interventions with intrapersonal BCS components, participants who received intrapersonal BCSs exhibited no significant changes in total PA at 1 week (192 vs 190 PA minutes per day; adjusted difference, 1.8 [95% CI, -8.6 to 12.2]; P = .73), 6 months (183 vs 187 PA minutes per day; adjusted difference, -3.9 [95% CI, -15.0 to 7.1]; P = .49), or 12 months (177 vs 186 PA minutes per day; adjusted difference, -8.8 [95% CI, -20.5 to 2.9]; P = .14) after the intervention. Interactions between intrapersonal and interpersonal BCSs were not significant. In this randomized clinical trial, older adults with low levels of PA who received interpersonal BCSs, the exercise program, and a PA monitor exhibited significant increases in their PA for up to 12 months after the intervention. Intrapersonal BCSs elicited no significant PA changes and did not interact with interpersonal BCSs. Our findings suggest that because effects of a PA intervention on sustained increases in older adults' PA were augmented with interpersonal but not intrapersonal BCSs, approaches to disseminating and implementing the intervention should be considered. ClinicalTrials.gov Identifier: NCT03326141.

SWOG S1820: A pilot randomized trial of the Altering Intake, Managing Bowel Symptoms Interventionin Survivors of Rectal Cancer.

Survivors of rectal cancer experience persistent bowel dysfunction after treatments. Dietary interventions may be an effective approach for symptom management and posttreatment diet quality. SWOG S1820 was a pilot randomized trial of the Altering Intake, Managing Symptoms in Rectal Cancer (AIMS-RC) intervention for bowel dysfunction in survivors of rectal cancer. Ninety-three posttreatment survivors were randomized to the AIMS-RC group (N=47) or the Healthy Living Education attention control group (N=46) after informed consent and completion of a prerandomization run-in. Outcome measures were completed at baseline and at 18 and 26weeks postrandomization. The primary end point was total bowel function score, and exploratory end points included low anterior resection syndrome (LARS) score, quality of life, dietary quality, motivation, self-efficacy, and positive/negative affect. Most participants were White and college educated, with a mean age of 55.2years and median time since surgery of 13.1months. There were no statistically significant differences in total bowel function score by group, with the AIMS-RC group demonstrating statistically significant improvements in the exploratory end points of LARS (p=.01) and the frequency subscale of the bowel function index (p=.03). The AIMS-RC group reported significantly higher acceptability of the study. SWOG S1820 did not provide evidence of benefit from the AIMS-RC intervention relative to the attention control. Select secondary end points did demonstrate improvements. The study was highly feasible and acceptable for participants in the National Cancer Institute Community Oncology Research Program. Findings provide strong support for further refinement and effectiveness testing of the AIMS-RC intervention.