A randomized controlled trial of a novel artificial-intelligence based smartphone application to optimize the management of cancer-related pain.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 76-76 ◽  
Author(s):  
Mihir M. Kamdar ◽  
Amanda Jayne Centi ◽  
Nils Fischer ◽  
Kamal Jethwani
Keyword(s):  
Artificial Intelligence ◽  
Randomized Controlled Trial ◽  
Cancer Pain ◽  
Cancer Treatment ◽  
Usual Care ◽  
Healthcare Utilization ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Patients With Cancer ◽  
Randomized Controlled

76 Background: Cancer pain affects 70-90% of advanced malignancy patients, resulting in impaired quality of life and increased healthcare utilization. Novel care delivery models are needed to optimize care for patients dealing with cancer-related pain in between clinic visits. ePAL is a smartphone application(app) that regularly monitors pain and uses artificial intelligence(AI) to differentiate urgent from non-urgent issues to intercede in real time. The purpose of this randomized controlled trial was to determine ePAL's impact on pain severity, attitudes toward cancer treatment, and healthcare utilization in patients with cancer pain. Methods: MGH Palliative Care Clinic Patients with pain from metastatic, solid-organ cancer (n=112) were recruited and randomized to either a control group (n=56) that received usual care or an intervention group (n=56) that used the ePAL app in addition to usual care for 8 weeks. The app assessed pain 3 times/week and questionnaires about pain (BPI), attitudes towards cancer treatment(BQ-II), and general anxiety(GAD-7) were given at 0, 4, and 8 weeks. A repeated measures mixed model approach assessed how outcome measures changed over time. Models controlled for baseline differences at enrollment and random slopes in addition to baseline depression score, age and sex(alpha=0.05). Results: Pain severity (BPI) and negative attitudes toward cancer pain treatment (BQ-II) decreased significantly for those using the app compared to controls(coeff. -0.09, 95% CI: -0.17, -0.007, p=0.034 and coeff. -0.037, 95% CI: -0.072, -0.001, p=0.042 respectively). Anxiety scores increased for those using ePAL compared to controls (coeff. 0.21, 95% CI: 0.039, 0.37, p=0.015). Over 8-weeks, ePAL users had 40% fewer inpatient hospital admissions compared to controls (n=15 vs. n=25, p=0.048). Conclusions: To our knowledge, this is the first mobile app to utilize AI and clinical algorithms to significantly decrease pain and reduce overall inpatient hospitalizations in patients with cancer-related pain. Clinical trial information: NCT02069743.

scholarly journals A Randomized Controlled Trial of a Standardized Educational Intervention for Patients with Cancer Pain

2010 ◽  
Vol 40 (1) ◽  
pp. 49-59 ◽  
Author(s):  
Melanie R. Lovell ◽  
Peta M. Forder ◽  
Martin R. Stockler ◽  
Phyllis Butow ◽  
Esther M. Briganti ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Pain ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Patients With Cancer ◽  
Randomized Controlled

scholarly journals A Web-Based Lifestyle Intervention Aimed at Improving Cognition in Patients With Cancer Returning to Work in an Outpatient Setting: Protocol for a Randomized Controlled Trial

10.2196/22670 ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. e22670
Author(s):  
A Josephine Drijver ◽  
Jaap C Reijneveld ◽  
Linda M P Wesselman ◽  
Martin Klein
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Treatment ◽  
Cognitive Functioning ◽  
Lifestyle Intervention ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Web Based ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Returning To Work

Background A high percentage of patients with cancer experience cognitive impairment after cancer treatment, resulting in a decreased health-related quality of life and difficulty returning to work. Consequently, there is a need for effective treatment options to improve cognitive functioning in these patients. In a healthy aging population, multidomain web-based lifestyle interventions have been found to be effective in preventing cognitive decline and improving cognitive functioning. Objective This study aims to investigate the feasibility and effectiveness of the web-based lifestyle intervention Mijn Fitte Brein (My Fit Brain [MFB]) on cognitive functioning in patients with cancer returning to work. Methods The study consists of a feasibility study (N=10), followed by a randomized controlled trial (RCT; N=220). Patients will be recruited by their occupational physicians after their return to work following cancer treatment. Mijn Fitte Brein is organized into 4-week cycles in which patients set a lifestyle goal using the Goal Attainment Scale, receive weekly tips and support, and finally evaluate whether they succeeded in achieving this goal. Lifestyle goals are based on 6 domains: physical exercise, diet, sleep, stress, alcohol use, and smoking. In the feasibility study, data on user experience (structured interview) and usability, assessed with the Post-Study System Usability Scale, will be collected and used to optimize Mijn Fitte Brein. In the RCT, patients will be randomized 1:1 between an intervention group and a control group. Patients will be assessed at baseline, 3 months, and 6 months. The primary outcome measure is subjective cognitive functioning, assessed with the Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog). Secondary outcome measures are lifestyle, objective cognitive functioning, and work and psychosocial factors. Results Recruitment for the feasibility study has started in February 2020. As of July 2020, however, no patients have been enrolled (due to COVID-19 restrictions). The findings of the feasibility study will be used to optimize the Mijn Fitte Brein intervention. Enrollment for the RCT will continue when possible. The feasibility study will take 6 months (including making adjustments to the intervention), and the RCT will take 2 years. The final results are expected in 2024. The results of the feasibility study and the RCT will be published in peer-reviewed journals. Conclusions This is the first time the feasibility and efficacy of a multidomain web-based lifestyle intervention will be studied in patients with cancer. If Mijn Fitte Brein is found to be effective in decreasing cognitive complaints in these patients returning to work, it will be a promising treatment option because of being both affordable and accessible. Trial Registration Netherlands Trial Register NL8407; https://www.trialregister.nl/trial/8407 International Registered Report Identifier (IRRID) DERR1-10.2196/22670

scholarly journals A Web-Based Lifestyle Intervention Aimed at Improving Cognition in Patients With Cancer Returning to Work in an Outpatient Setting: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
A Josephine Drijver ◽  
Jaap C Reijneveld ◽  
Linda M P Wesselman ◽  
Martin Klein
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Treatment ◽  
Cognitive Functioning ◽  
Lifestyle Intervention ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Web Based ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Returning To Work

BACKGROUND A high percentage of patients with cancer experience cognitive impairment after cancer treatment, resulting in a decreased health-related quality of life and difficulty returning to work. Consequently, there is a need for effective treatment options to improve cognitive functioning in these patients. In a healthy aging population, multidomain web-based lifestyle interventions have been found to be effective in preventing cognitive decline and improving cognitive functioning. OBJECTIVE This study aims to investigate the feasibility and effectiveness of the web-based lifestyle intervention Mijn Fitte Brein (My Fit Brain [MFB]) on cognitive functioning in patients with cancer returning to work. METHODS The study consists of a feasibility study (N=10), followed by a randomized controlled trial (RCT; N=220). Patients will be recruited by their occupational physicians after their return to work following cancer treatment. Mijn Fitte Brein is organized into 4-week cycles in which patients set a lifestyle goal using the Goal Attainment Scale, receive weekly tips and support, and finally evaluate whether they succeeded in achieving this goal. Lifestyle goals are based on 6 domains: physical exercise, diet, sleep, stress, alcohol use, and smoking. In the feasibility study, data on user experience (structured interview) and usability, assessed with the Post-Study System Usability Scale, will be collected and used to optimize Mijn Fitte Brein. In the RCT, patients will be randomized 1:1 between an intervention group and a control group. Patients will be assessed at baseline, 3 months, and 6 months. The primary outcome measure is subjective cognitive functioning, assessed with the Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog). Secondary outcome measures are lifestyle, objective cognitive functioning, and work and psychosocial factors. RESULTS Recruitment for the feasibility study has started in February 2020. As of July 2020, however, no patients have been enrolled (due to COVID-19 restrictions). The findings of the feasibility study will be used to optimize the Mijn Fitte Brein intervention. Enrollment for the RCT will continue when possible. The feasibility study will take 6 months (including making adjustments to the intervention), and the RCT will take 2 years. The final results are expected in 2024. The results of the feasibility study and the RCT will be published in peer-reviewed journals. CONCLUSIONS This is the first time the feasibility and efficacy of a multidomain web-based lifestyle intervention will be studied in patients with cancer. If Mijn Fitte Brein is found to be effective in decreasing cognitive complaints in these patients returning to work, it will be a promising treatment option because of being both affordable and accessible. CLINICALTRIAL Netherlands Trial Register NL8407; https://www.trialregister.nl/trial/8407 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/22670

A randomized controlled trial of a novel artificial intelligence-based smartphone application to optimize the management of cancer-related pain.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11514-11514 ◽  
Author(s):  
Mihir Kamdar ◽  
Amanda Jayne Centi ◽  
Stephen Agboola ◽  
Nils Fischer ◽  
Simone Rinaldi ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Cancer Pain ◽  
Patient Reported Outcomes ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Pain Severity ◽  
Control Group ◽  
Randomized Controlled ◽  
Patient Reported

11514 Background: Cancer pain is a significant problem that impairs patient quality of life and increases healthcare utilization. ePAL is a smartphone application that utilizes patient-reported outcomes (PROs) and artificial intelligence (AI) to optimize cancer pain management. This randomized controlled trial examined the impact of ePAL on cancer pain severity, attitudes toward cancer pain, and healthcare utilization. Methods: Patients with pain from metastatic solid tumors (n = 112) undergoing treatment in a palliative care clinic were randomized to either a control group (n = 56) that received usual care or an intervention group (n = 56) that received ePAL in addition to usual care for 8 weeks. Measures of pain severity (Brief Pain Inventory), attitudes towards cancer treatment (Barriers Questionnaire II) and anxiety (General Anxiety Disorder-7) were assessed. We used repeated measures mixed modeling to assess change in outcome measures over time. We also conducted a chart review to identify pain-related hospital admissions and emergency department (ED) visits and compared risk between study groups. Results: Pain severity (BPI) and negative attitudes toward cancer treatment (BQ-II) decreased significantly for those assigned to ePAL compared to controls (ß = -0.09, p = 0.034 and ß = -0.037, p = 0.042, respectively). Patients assigned to ePAL reported higher anxiety scores compared to controls (ß = 0.21, p = 0.015). Patients assigned to ePAL had significantly fewer pain-related hospital admissions (n = 4 vs. n = 20, per patient risk ratio 0.31, p = 0.018) and fewer pain-related admissions through the ED (n = 2 vs. n = 14, per patient risk ratio 0.18, p = 0.008) compared to control group. Conclusions: To our knowledge, this is the first mobile app to utilize patient reported outcomes and artificial intelligence to significantly decrease pain scores and pain-related hospitalizations in patients with cancer-related pain. Future directions include examining the efficacy of ePAL in settings with limited access to palliative care.

scholarly journals Building family caregiver skills using a simulation-based intervention for care of patients with cancer: protocol for a randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Susan R. Mazanec ◽  
Eric Blackstone ◽  
Barbara J. Daly
Keyword(s):  
Randomized Controlled Trial ◽  
Radiation Therapy ◽  
Usual Care ◽  
Family Caregivers ◽  
Controlled Trial ◽  
Nursing Intervention ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Simulation Based ◽  
And Training

Abstract Background Family caregivers of patients with cancer undergoing radiation therapy experience significant distress and challenges related to high symptom burden and complex care demands. This is particularly true for caregivers of patients with head and neck, esophageal, anal, rectal, and lung cancers, who are often receiving combined-modality treatment and may have tracheostomy tubes, gastrostomy tubes, or colostomies/ileostomies. This study aims to evaluate a simulation-based nursing intervention to provide information, support, and training to caregivers during radiation therapy. Methods This randomized controlled trial will include a sample of 180 patients and their family caregivers. Caregivers assigned to the control group will receive usual care and an informational booklet from the National Cancer Institute (NCI). Those in the intervention group will receive usual care, the NCI booklet, and three meetings with a nurse interventionist during radiation treatment followed by a booster call two weeks posttreatment. Intervention sessions focus on themes consistent with the trajectory of radiation therapy: the patient experience/needs, the caregiver experience and dyad communication, and transition to survivorship. Outcomes are measured at baseline, end of treatment (T2), and 4 (T3) and 20 (T4) weeks posttreatment, with the primary outcome being caregiver anxiety at T4. Discussion This trial is innovative in its use of simulation in a psychoeducational intervention for family caregivers. The intervention is administered at point-of-care and aimed at feasibility for integration into clinical practice. Patient quality of life and healthcare utilization measures will assess how providing support and training to the caregiver may impact patient outcomes. Trial registration The trial was registered on 08/14/2019 at ClinicalTrials.gov (identifier NCT04055948).

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

Rationale, design, and challenges with implementing a clinical intervention to teach appropriate gestational weight gain (TAGG): Protocol of a Randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Awathif Mackeen ◽  
Danielle Downs ◽  
Vonda Hetherington ◽  
Shawnee Lutcher ◽  
Jacob Mowery ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Gestational Diabetes ◽  
Usual Care ◽  
Gestational Weight Gain ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Household Food Security ◽  
Gestational Weight ◽  
Randomized Controlled

BACKGROUND Excessive gestational weight gain (GWG) has public health implications including preterm birth, preeclampsia, gestational diabetes, and cesarean delivery. In an effort to mitigate adverse consequences of excessive GWG, this study tests a health intervention that includes enhancements to improve knowledge and awareness of appropriate GWG, and patient-centered nutritional counseling to promote appropriate GWG. OBJECTIVE The primary objective of the study was to increase the proportion of women who are managing their GWG as recommended by the IOM.4,5 METHODS This randomized controlled trial was conducted at Geisinger in Pennsylvania where excessive GWG is common among women with pre-conception obesity. Eligible, consenting participants with pre-pregnancy body mass index >30.0 kg/m2 were randomized (1:1) to: 1) Usual Care: usual written educational materials and counseling by an obstetric care provider or 2) Enhanced Care: Usual Care plus a) a personalized letter from a physician detailing appropriate GWG, b) exposure to individualized GWG chart in the electronic health record via the patient portal, and c) a consult with a Registered Dietitian Nutritionist and follow-up via tele-health counseling (10-20 mins/1-2 weeks) for the duration of the pregnancy. RESULTS The primary outcome was the proportion of women that gain less than 20 pounds over the course of the pregnancy. Secondary outcomes include knowledge, expectations, and attitude about pregnancy weight gain; increased self-efficacy for ability to eat healthy and being physically active to manage weight; and eating behavior. Potential moderators that will be explored include sleep, perceived stress, perceived involvement in care, and household food security. Data collection has been completed as of November 2019. CONCLUSIONS As GWG care was initiated for mothers with pre-pregnancy BMI >30 kg/m2 within the first and second trimesters, the intervention may have the additional benefit of reducing other adverse pregnancy outcomes including the incidence of gestational diabetes due to healthier rates of GWG. In addition to assessing appropriate GWG, this project will assess eating habits, physical activity, GWG attitudes, sleep quality, and psychological measures, all of which are associated with GWG. Exploratory mediators including perceived stress and food insecurity will also be evaluated. CLINICALTRIAL ClinicalTrials.gov NCT02963428

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