Dataset Information

A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery.

ABSTRACT:

Objective

Behavioral cancer pain interventions are efficacious for improving important pain outcomes; yet, traditional in-person delivery limits patient access. This study compared videoconference-delivered mobile health pain coping skills training (mPCST) to in-person pain coping skills training (PCST-traditional).

Methods

This study was a randomized, noninferiority trial with cancer patients. Participants (N = 178) were randomly assigned to four, 45-minute sessions of mPCST or PCST-traditional. Session content focused on evidence-based cognitive and behavioral pain management skills. Assessments were completed at baseline, posttreatment, and 3-month posttreatment, and included measures of primary intervention outcomes (ie, pain severity and pain interference) and secondary intervention outcomes (ie, physical symptoms, psychological distress, physical well-being, and self-efficacy). The main study aim tested whether mPCST was more accessible (defined as feasibility, acceptability, patient burden, and engagement) than PCST-traditional. The second aim tested whether mPCST was noninferior to PCST-traditional.

Results

mPCST demonstrated significantly greater feasibility (ie, attrition, adherence, and time to completion) than PCST-traditional. Both groups reported similar patient burden and engagement as well as a high degree of acceptability. All intervention outcomes demonstrated noninferiority at posttreatment and, with the exception of physical symptoms, 3-month posttreatment. Concerning the primary intervention outcomes, 95% CIs for the mean differences (d) were below the noninferiority margin of 1 for pain severity (posttreatment d = 0.09, 95% CI, -0.63-0.81; 3 months d = -0.43 95% CI, -1.22-0.36) and pain interference (posttreatment d = -0.11, 95% CI, -0.99-0.76; 3 months d = -0.26 95% CI, -1.14-0.62).

Conclusion

mPCST is highly accessible and noninferior to PCST-traditional.

SUBMITTER: Kelleher SA

PROVIDER: S-EPMC10141528 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery.

Kelleher Sarah A SA Winger Joseph G JG Dorfman Caroline S CS Ingle Krista K KK Moskovich Ashley A AA Abernethy Amy P AP Keefe Francis J FJ Samsa Greg P GP Kimmick Gretchen G GG Somers Tamara J TJ

Psycho-oncology 20190619 8

<h4>Objective</h4>Behavioral cancer pain interventions are efficacious for improving important pain outcomes; yet, traditional in-person delivery limits patient access. This study compared videoconference-delivered mobile health pain coping skills training (mPCST) to in-person pain coping skills training (PCST-traditional).<h4>Methods</h4>This study was a randomized, noninferiority trial with cancer patients. Participants (N = 178) were randomly assigned to four, 45-minute sessions of mPCST or P ...[more]

PMID: 31162756

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Project description:BackgroundCognitive behavioral therapy is known to improve the management of chronic pain. However, the components of this therapy are still being investigated and debated.ObjectiveThis study aimed to examine the effectiveness of an integrated cognitive behavioral therapy program with new components (attention-shift, memory work, video feedback, and image training) delivered via videoconferencing.MethodsThis study was unblinded and participants were recruited and assessed face-to-face in the outpatient department. We conducted a randomized controlled trial for chronic pain to compare 16 weekly videoconference-based cognitive behavioral therapy (vCBT) sessions provided by a therapist with treatment as usual (TAU). Thirty patients (age range, 22-75 years) with chronic pain were randomly assigned to either vCBT (n=15) or TAU (n=15). Patients were evaluated at week 1 (baseline), week 8 (midintervention), and week 16 (postintervention). The primary outcome was the change in pain intensity, which was recorded using the numerical rating scale at 16 weeks from the baseline. Secondary outcomes were pain severity and pain interference, which were assessed using the Brief Pain Inventory. Additionally, we evaluated disability, pain catastrophizing cognition, depression, anxiety, quality of life, and cost utility.ResultsIn the eligibility assessment, 30 patients were eventually randomized and enrolled; finally, 15 patients in the vCBT and 14 patients in the TAU group were analyzed. Although no significant difference was found between the 2 groups in terms of changes in pain intensity by the numerical rating scale scores at week 16 from baseline (P=.36), there was a significant improvement in the comprehensive evaluation of pain by total score of Brief Pain Inventory (-1.43, 95% CI -2.49 to -0.37, df=24; P=.01). Further, significant improvement was seen in pain interference by using the Brief Pain Inventory (-9.42, 95% CI -14.47 to -4.36, df=25; P=.001) and in disability by using the Pain Disability Assessment Scale (-1.95, 95% CI -3.33 to -0.56, df=24; P=.008) compared with TAU. As for the Medical Economic Evaluation, the incremental cost-effectiveness ratio for 1 year was estimated at 2.9 million yen (about US $25,000) per quality-adjusted life year gained.ConclusionsThe findings of our study suggest that integrated cognitive behavioral therapy delivered by videoconferencing in regular medical care may reduce pain interference but not pain intensity. Further, this treatment method may be cost-effective, although this needs to be further verified using a larger sample size.Trial registrationUniversity Hospital Medical Information Network UMIN000031124; https://tinyurl.com/2pr3xszb.

Project description:PurposeThe ongoing integration of cancer genomic testing into routine clinical care has led to increased demand for cancer genetic services. To meet this demand, there is an urgent need to enhance the accessibility and reach of such services, while ensuring comparable care delivery outcomes. This randomized trial compared 1-year outcomes for telephone genetic counseling with in-person counseling among women at risk of hereditary breast and/or ovarian cancer living in geographically diverse areas.Patients and methodsUsing population-based sampling, women at increased risk of hereditary breast and/or ovarian cancer were randomly assigned to in-person (n = 495) or telephone genetic counseling (n = 493). One-sided 97.5% CIs were used to estimate the noninferiority effects of telephone counseling on 1-year psychosocial, decision-making, and quality-of-life outcomes. Differences in test-uptake proportions for determining equivalency of a 10% prespecified margin were evaluated by 95% CIs.ResultsAt the 1-year follow-up, telephone counseling was noninferior to in-person counseling for all psychosocial and informed decision-making outcomes: anxiety (difference [d], 0.08; upper bound 97.5% CI, 0.45), cancer-specific distress (d, 0.66; upper bound 97.5% CI, 2.28), perceived personal control (d, -0.01; lower bound 97.5% CI, -0.06), and decisional conflict (d, -0.12; upper bound 97.5% CI, 2.03). Test uptake was lower for telephone counseling (27.9%) than in-person counseling (37.3%), with the difference of 9.4% (95% CI, 2.2% to 16.8%). Uptake was appreciably higher for rural compared with urban dwellers in both counseling arms.ConclusionAlthough telephone counseling led to lower testing uptake, our findings suggest that telephone counseling can be effectively used to increase reach and access without long-term adverse psychosocial consequences. Further work is needed to determine long-term adherence to risk management guidelines and effective strategies to boost utilization of primary and secondary preventive strategies.

Project description:BackgroundThe prevalence of major depressive disorder (MDD) poses significant global health challenges, with available treatments often insufficient in achieving remission for many patients. Digital health technologies, such as SMS text messaging-based cognitive behavioral therapy, offer accessible alternatives but may not reach all individuals. Email communication presents a secure avenue for health communication, yet its effectiveness compared to SMS text messaging in providing mental health support for patients with MDD remains uncertain.ObjectiveThis study aims to compare the efficacy of email versus SMS text messaging as delivery platforms for supporting patients with MDD, addressing a critical gap in understanding optimal digital interventions for mental health care.MethodsA randomized noninferiority pilot trial was conducted, comparing outcomes for patients receiving 6-week daily supportive messages via email with those receiving messages via SMS text message. This duration corresponds to a minimum of 180 days of message delivery. The supportive messages maintained consistent length and structure across both delivery methods. Participants (N=66) were recruited from the Access 24/7 clinic in Edmonton, Alberta, among those who were diagnosed with MDD. The outcomes were measured at baseline and 6 months after enrollment using the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and the World Health Organization Well-Being Index (WHO-5).ResultsMost of the participants were females (n=43, 65%), aged between 26 and 40 years (n=34, 55%), had high school education (n=35, 58%), employed (n=33, 50%), and single (n=24, 36%). Again, most participants had had no history of any major physical illness (n=56, 85%) and (n=61, 92%) responded "No" to having a history of admission for treatment of mood disorders. There was no statistically significant difference in the mean changes in PHQ-9, GAD-7, and WHO-5 scores between the email and SMS text messaging groups (mean difference, 95% CI: -1.90, 95% CI -6.53 to 2.74; 5.78, 95% CI -1.94 to 13.50; and 11.85, 95% CI -3.81 to 27.51), respectively. Both supportive modalities showed potential in reducing depressive symptoms and improving quality of life.ConclusionsThe study's findings suggest that both email and SMS text messaging interventions have equivalent effectiveness in reducing depression symptoms among individuals with MDD. As digital technology continues to evolve, harnessing the power of multiple digital platforms for mental health interventions can significantly contribute to bridging the existing treatment gaps and improving the overall well-being of individuals with depressive conditions. Further research is needed with a larger sample size to confirm and expand upon these findings.Trial registrationClinicalTrials.gov NCT04638231; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8552095/.

Project description:BackgroundTobacco consumption is a leading cause of death and disease, killing >8 million people each year. Smoking cessation significantly reduces the risk of developing smoking-related diseases. Although combined treatment for addiction is promising, evidence of its effectiveness is still emerging. Currently, there is no published research comparing the effectiveness of blended smoking cessation treatments (BSCTs) with face-to-face (F2F) treatments, where web-based components replace 50% of the F2F components in blended treatment.ObjectiveThe primary objective of this 2-arm noninferiority randomized controlled trial was to determine whether a BSCT is noninferior to an F2F treatment with identical ingredients in achieving abstinence rates.MethodsThis study included 344 individuals who smoke (at least 1 cigarette per day) attending an outpatient smoking cessation clinic in the Netherlands. The participants received either a blended 50% F2F and 50% web-based BSCT or only F2F treatment with similar content and intensity. The primary outcome measure was cotinine-validated abstinence rates from all smoking products at 3 and 15 months after treatment initiation. Additional measures included carbon monoxide-validated point prevalence abstinence; self-reported point prevalence abstinence; and self-reported continuous abstinence rates at 3, 6, 9, and 15 months after treatment initiation.ResultsNone of the 13 outcomes showed statistically confirmed noninferiority of the BSCT, whereas 4 outcomes showed significantly (P<.001) inferior abstinence rates of the BSCT: cotinine-validated point prevalence abstinence rate at 3 months (difference 12.7, 95% CI 6.2-19.4), self-reported point prevalence abstinence rate at 6 months (difference 19.3, 95% CI 11.5-27.0) and at 15 months (difference 11.7, 95% CI 5.8-17.9), and self-reported continuous abstinence rate at 6 months (difference 13.8, 95% CI 6.8-20.8). The remaining 9 outcomes, including the cotinine-validated point prevalence abstinence rate at 15 months, were inconclusive.ConclusionsIn this high-intensity outpatient smoking cessation trial, the blended mode was predominantly less effective than the traditional F2F mode. The results contradict the widely assumed potential benefits of blended treatment and suggest that further research is needed to identify the critical factors in the design of blended interventions.Trial registrationNetherlands Trial Register 27150; https://onderzoekmetmensen.nl/nl/trial/27150.International registered report identifier (irrid)RR2-doi.org/10.1186/s12889-016-3851-x.

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Dataset Information

A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery.

Objective

Methods

Results

Conclusion

Publications

A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery.

Similar Datasets

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