Mediators Of Intervention Efficacy Research Articles

Abstract PO4-18-10: Randomized controlled trial of Young, Empowered & Strong (YES), a web-based patient-reported symptom monitoring and self-management portal for adolescent and young adult (AYA) breast cancer (BC) survivors

Abstract Background: BC is the most common malignancy diagnosed in AYAs. AYAs develop more biologically aggressive BC and present at more advanced stages, necessitating more intensive therapy with curative intent. While acute physical sequelae often resolve following initial treatment, the long-term physical and psychosocial impact of BC on a survivor’s life may worsen or emerge in survivorship. This impact includes symptoms (e.g., sexual problems, anxiety, fatigue, stress, sleep issues, hot flashes) as well as concerns unique to, or accentuated by, being young (e.g., fertility, genetics, childrearing, educational/work attainment). With provider attention to these issues often sub-optimal, strategies that empower patients have the potential to improve their well-being. To engage and activate AYA BC survivors, we developed YES, a web-based portal that leverages electronic patient-reported outcomes (ePROs) to facilitate self-monitoring and management of symptoms/AYA concerns. In contrast to ePRO models dependent on clinician interaction, our approach emphasizes self-management of chronic survivorship concerns outside of the clinic environment. This model is grounded in the reality that most clinicians have limited bandwidth to address these needs and considers that AYAs can have competing demands (e.g., missing work, child-care) that may make accessing in-person support challenging. Methods: The YES study is a randomized controlled trial of the YES intervention vs. usual care. YES supports participants to 1) self-monitor needs/symptoms; and 2) provides a repository for information and resources on self-management of symptoms/AYA concerns. Eligibility criteria include: female, age 15-39 years at diagnosis, stage 0-III BC, within 3 years of diagnosis, no recurrent/second primary BC, no other malignancy since BC diagnosis, and English speaking. Participants randomized to the YES arm are prompted through a monthly text or email to complete an ePRO assessment regarding current symptoms/AYA concerns. For each symptom/concern endorsed, information/resources to address the symptom/concern is automatically provided via the YES portal. The portal is monitored, and providers are contacted if participants report severe distress or suicidality. YES also provides peer support via a chat room and self-support through a journaling platform in the portal. Participants in the usual care group are offered access to YES for up to 3 months at the end of their 9-month study participation. All participants complete a REDCap survey with validated measures of quality of life (QOL), symptoms, and other PROs at baseline, 3, 6, and 9 months after randomization and provide a dried blood spot specimen via a self-administration kit at baseline and 6 months. The primary study aim is to determine the efficacy of YES vs. usual care in improving life quality measured by the QOL in Adult Cancer Survivors [QLACS] scale at 6 months post-randomization. With a planned sample size of 360 participants, the study will have ≥90% power to detect a 6-point mean change (6 months vs. baseline) in the cancer-specific QLACS score between arms. Secondary outcomes include efficacy of YES in reducing symptoms/AYA concerns at 6 months and sustainability of the effects of YES at 9 months. Repeated measures regression will be used with link functions selected based on the type of outcome data analyzed. Exploratory aims will evaluate moderators and mediators of intervention efficacy and the effects of YES on inflammatory biomarkers. At study completion, a subset of 30 participants diverse in age, race, ethnicity, and gender identity are invited to participate in an interview to understand their survivorship preferences/concerns and to understand how the portal supported their self-management. The YES trial opened to enrollment in 9/2021. As of 6/2023, 245 participants are enrolled. Clinical Trials Information: NCT04906200 Citation Format: Shoshana Rosenberg, Yue Zheng, Dawn Hershman, Craig Snow, Kate Dibble, Magnolia Contreras, Noel Roma, Nabihah Tayob, Michelle Naughton, Ann Partridge. Randomized controlled trial of Young, Empowered & Strong (YES), a web-based patient-reported symptom monitoring and self-management portal for adolescent and young adult (AYA) breast cancer (BC) survivors [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 PO4-18-10.

“INTEGRO INTEGRated Psychotherapeutic InterventiOn” on the Management of Chronic Pain in Patients with Fibromyalgia: The Role of the Therapeutic Relationship

Fibromyalgia (FM) is a chronic disease characterized by a heterogeneous set of physical and psychological conditions. The chronic experience of disability felt by patients and the impact on quality of life (QoL) of the disease may worsen the cognitive reappraisal ability and contribute to maintaining an altered pain modulation mechanism. This paper presents the study protocol of an INTEGRated psychotherapeutic interventiOn on the management of chronic pain in patients with fibromyalgia (INTEGRO). The aim of the study is to investigate the efficacy of an integrated psychotherapeutic intervention focused on pain management on QoL and pain perception, in a pilot sample of 45 FM patients with idiopathic chronic pain. The contribution of perceived therapeutic relationship (alliance) and physiological attunement, in both the patient and therapist, will be considered as possible mediators of intervention efficacy. Attachment dimensions, traumatic experiences, difficulties in emotion regulation, mindfulness attitude and psychophysiological profile will also be considered as covariates. The objectives are to evaluate longitudinally if patients will experience an increase in QoL perception (primary endpoint), pain-managing self-efficacy and emotion-regulation abilities as well as a reduction in pain intensity (secondary endpoints), considering the mediating role of perceived therapeutic alliance and physiological attunement in both the patient and therapist.

Examining mediators of intervention efficacy in a randomised controlled m-health trial to improve physical activity and sleep health in adults

Objectives: Examining mediators of intervention efficacy in an m-health intervention targeting physical activity and sleep in 160 Australian adults.Design: Nationwide randomised controlled trial.Main outcome measures: Moderate- and vigorous-intensity physical activity (MVPA), assessed using the Active Australia Questionnaire; sleep quality (Pittsburgh Sleep Quality Index); and sleep hygiene practices (Sleep Hygiene Index). Hypothesised psychosocial (e.g. self-efficacy) and behavioural (i.e. MVPA, sleep quality, sleep hygiene) mediators were tested on primary endpoint data at 3 months using bias-corrected bootstrapping (PROCESS 2 for SPSS). All outcomes and mediators were assessed using self-report.Results: At three months, the intervention had significantly improved sleep quality (d = 0.48, 95% CI: −2.26, −0.33, p = 0.009) and sleep hygiene (d = 0.40, 95% CI: −3.10, −0.19, p = 0.027). Differences in MVPA were not significant (d = 0.24, 95% CI: −35.53, 254.67, p = 0.139). Changes in MVPA were mediated by self-efficacy, perceived capability, environment, social support, intentions and planning, some of which showed inconsistent mediation (suppression). None of the hypothesised psychosocial factors mediated sleep outcomes. Changes in sleep hygiene mediated changes in sleep quality.Conclusions: Several psychosocial factors mediated changes in physical activity but not in sleep outcomes. Mediation effects of sleep hygiene on sleep quality highlight the importance of providing evidence-based strategies to improve sleep quality.

Mediators of physical activity between standard exercise and exercise video games.

Exercise video games (EVGs) may offer an attractive, sustainable alternative or supplement to traditional modes of exercise. Understanding the psychosocial factors that influence the appeal of EVGs is important for improving the efficacy of video games as a method of promoting the uptake and long-term maintenance of physical activity. This study examined changes in psychosocial constructs from self-determination theory and self-efficacy theory as mediators of intervention efficacy among 189 healthy, sedentary adults randomized to 12-week programs of either EVGs or standard exercise (e.g., treadmill walking, stationary cycling) followed by 6 months of follow-up. The EVG group engaged in significantly more weekly minutes of moderate to vigorous physical activity (MVPA) at the end of treatment compared with the standard exercise group. Univariate and multivariate mediational models were used to examine theoretically derived psychosocial constructs as potential mediators of differential intervention effects. Univariate mediational models suggest a significant indirect effect of treatment on MVPA outcomes through enjoyment, self-efficacy, stress management, depressive symptoms, and positive engagement (p < .05). Multiple mediational analyses confirm all the univariate results (p < .05), with the exception of enjoyment. Differences in the efficacy of EVG versus standard exercise interventions were mediated by several psychosocial constructs, suggesting that qualities specific to game play may enhance adherence to physical activity both in and outside of the laboratory environment. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

An Evaluation of e-CHECKUP TO GO in Canada: The Mediating Role of Changes in Social Norm Misperceptions

ABSTRACTBackground: Alcohol use and related problems are key concerns among colleges, and web-based interventions to mitigate these issues are increasingly popular across campuses. A variety of programs are commercially available and have demonstrated efficacy in reducing alcohol use and consequences; however, little is known about how these programs reduce alcohol outcomes. Objectives: The e-CHECKUP TO GO program (e-CHUG) is the briefest electronic intervention available and over 600 institutions are using it internationally. The present study evaluates the impact of the e-CHUG program on drinking outcomes and examines changes in perceived norms as a potential mediator of intervention efficacy in a sample of first-year Canadian university residence students. This is the first Canadian evaluation of e-CHUG. Methods: First year Canadian university students (N = 245) living in residence in August 2014 participated in a randomized control trial to evaluate the efficacy of e-CHUG program compared to an assessment-only control condition. Follow-up assessments were completed at 3-months and 5-months. Norm misperceptions and drinking outcomes were measured. Results: At 3-month and 5-month follow-up assessments program participants had lower norm misperceptions about peers drinking compared to control participants. Changes in norm misperceptions at 3-months mediated the effect of the program on drinking outcomes at 5-months. There were no sex differences in the associations. Conclusions/Importance: Findings suggest that e-CHECKUP TO GO may be a promising strategy for addressing norm misperceptions and subsequently drinking for Canadian students.

Prototype Willingness Model Drinking Cognitions Mediate Personalized Normative Feedback Efficacy.

Personalized normative feedback (PNF) interventions have been shown to be efficacious at reducing college student drinking. Because descriptive norms have been shown to mediate PNF efficacy, the current study focused on examining additional prototype willingness model social reaction cognitions, namely, prototypes and willingness, as mediators of intervention efficacy. We expected the PNF interventions to be associated with increased prototype favorability of students who do not drink, which would in turn be associated with decreased willingness to drink and subsequently, less drinking. The current study included 622 college students (53.2% women; 62% Caucasian) who reported one or more heavy drinking episodes in the past month and completed baseline and three-month follow-up assessments. As posited by the framework of the prototype willingness model, sequential mediation analyses were conducted to evaluate increases in abstainer prototype favorability on willingness on drinking, and subsequently willingness to drink on drinking behavior. Mediation results revealed significant indirect effects of PNF on three-month drinking through three-month prototypes and willingness, indicating that the social reaction pathway of the prototype willingness model was supported. Findings have important implications for PNF interventions aiming to reduce high-risk drinking among college students. Study findings suggest that we should consider looking at additional socially-based mediators of PNF efficacy in addition to perceived descriptive norms.

Internet-based personalized feedback to reduce 21st-birthday drinking: A randomized controlled trial of an event-specific prevention intervention.

This article presents an initial randomized controlled trial of an event-specific prevention intervention. Participants included 295 college students (41.69% male, 58.31% female) who intended to consume 2 or more drinks on their 21st birthday. Participants completed a screening/baseline assessment approximately 1 week before they turned 21 and were randomly assigned to receive Web-based personalized feedback or assessment only. Feedback included normative information, protective behaviors, and personalized blood alcohol concentration information. A follow-up assessment was completed approximately 1 week after a student's birthday. Results indicated a significant intervention effect in reducing estimated blood alcohol concentration (d = 0.33). The intervention effect was moderated by 21st-birthday drinking intentions, and the intervention was primarily effective among those who intended to reach higher levels of intoxication. Results provide some support for normative information as a mediator of intervention efficacy. Overall results provide support for Web-based personalized feedback as an intervention approach for specific events associated with extreme drinking.