Supporting self-management amongst young people with acne vulgaris: feasibility randomised trial of a web-based behavioural intervention (Preprint)

2020 ◽  
Author(s):  
Athena Ip ◽  
Ingrid Muller ◽  
Adam Geraghty ◽  
Kate Rumsby ◽  
Beth Stuart ◽  
...  
Keyword(s):  
Young People ◽  
Usual Care ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Randomised Trial ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Self Management ◽  
Web Based ◽  
Topical Treatments

BACKGROUND Acne is a common skin condition that is most prevalent in young people. It can have substantial impact on quality of life, which can be minimised with appropriate use of topical treatments. Nonadherence to topical treatments for acne is common often leading to treatment failure. OBJECTIVE The objective of this study was to develop a web-based behavioural intervention to support self-management of acne and to assess the feasibility of recruitment, retention and engagement in a parallel unblinded randomised trial of the intervention compared with usual care alone. METHODS The intervention was developed iteratively using LifeGuide software and following the Person-Based Approach (PBA) to intervention development. The target behaviour was ‘Appropriate use of topical treatments’ and barriers and facilitators identified from the qualitative research and evidence from the wider literature were used to identify techniques to improve and promote their use. Young people with acne aged 14-25 years who had received treatment for acne within the last 6 months were invited to participate through mail-out from primary care practices in the South of England. Participants were randomised to: (1) usual care, or (2) usual care plus access to web-based intervention. Usage data was collected and a series of questionnaires including the primary outcome measure for skin specific quality of life (Skindex-16) were collected at baseline, 4-weeks and 6-weeks follow-up. RESULTS A total of 1193 participants were invited and 53 young people with acne were randomised to usual care (n=27) or usual care plus intervention (n=26). The response rate for the primary outcome measure (Skindex-16) was 87% at 4-weeks, 6-weeks or both time points. The estimate of mean scores between groups (with 95% confidence) using linear regression showed a trend in the direction of benefit for the web-based intervention group in the primary outcome measure (Skindex-16), and secondary measures (Patient Health Questionnaire 4 and the Problematic Experiences of Therapy Scale). Intervention usage data showed a high uptake of the core module in the usual care plus web-based intervention group with 23 of 26 (88%) completing the module. Uptake of the optional modules were low with less than half visiting each (Myth-busting quiz: 27%; Living with spots or acne: 42%; Oral antibiotics: 19%; What are spots or acne: 27%; Other treatments: 27%; Talking to your GP: 12%). CONCLUSIONS This study demonstrated the feasibility of delivering a trial of a web-based intervention to support self-management for young people with acne. Additional work is needed prior to a full definitive trial including enhancing engagement with the intervention, recruitment and follow-up rates. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 78626638; https://doi.org/10.1186/ISRCTN78626638.

scholarly journals Telephone-guided self-help for mental health difficulties in neurological conditions: a randomised pilot trial

2021 ◽  
pp. archdischild-2019-318577
Author(s):  
Sophie D Bennett ◽  
Isobel Heyman ◽  
Anna E Coughtrey ◽  
Sophia Varadkar ◽  
Terence Stephenson ◽  
...  
Keyword(s):  
Mental Health ◽  
Young People ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Mental Health Problems ◽  
Pilot Trial ◽  
Primary Outcome Measure ◽  
Self Help ◽  
Mental Health Difficulties ◽  
Neurological Conditions

ObjectiveThis study aimed to conduct a randomised pilot trial to assess the feasibility of a randomised controlled trial (RCT) to investigate the effect of telephone-guided self-help for the treatment of mental health difficulties in children with neurological conditions.DesignPreliminary RCT. The primary outcome measure was the Strengths and Difficulties Questionnaire.SettingNeurology clinics in a national tertiary paediatric hospital.PatientsYoung people attending neurology clinics who met criteria for mental health difficulties according to the Development and Wellbeing Assessment.Interventions12 weeks of telephone-guided self-help based on a modular approach to psychological therapy for children delivered to children and/or their parents (n=17; eight males; mean age 12.04 years, SD=3.34) or a waiting list for telephone-guided self-help with no additional intervention over 12 weeks (n=17; nine males; mean age 10.53 years, SD=3.14).Results124 participants completed the DAWBA, and 34 children and young people were entered into the trial. 65% of those randomised to the intervention arm completed the full intervention, and the intervention was acceptable to those completing it. However, there were significant problems related to lack of data completion (38% data loss for primary outcome measure), choice of control comparator and outcome measures. Due to significant loss of data at follow-up, the effect size findings are considered unreliable.ConclusionsFurther feasibility work should be conducted to improve data completeness before progression to a definitive trial of guided self-help for mental health problems in children with neurological conditions can be recommended.Trial registration numberISRCTN21184717.

scholarly journals Dignity Impact as a Primary Outcome Measure for Dignity Therapy

2018 ◽  
Vol 35 (11) ◽  
pp. 1417-1420 ◽  
Author(s):  
Lisa Scarton ◽  
Sungho Oh ◽  
Ashley Sylvera ◽  
Ralph Lamonge ◽  
Yingwei Yao ◽  
...  
Keyword(s):  
Palliative Care ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Meaning Making ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Care Group ◽  
Dignity Therapy ◽  
Feedback Questionnaire

Background: Feasibility of dignity therapy (DT) is well established in palliative care. Evidence of its efficacy, however, has been inconsistent and may stem from DT’s primary effects differing from the outcomes measured in previous studies. We proposed that DT effects were in the spiritual domain and created a new outcome measure, Dignity Impact Scale (DIS), from items previously used in a large randomized controlled trial (RCT). Objective: The purpose of this secondary analysis study was to examine properties of a new measure of dignity impact. Design: Using the DIS, we conducted reanalysis of posttest data from a large 3-arm, multi-site RCT study. Setting/Participants: Participants were receiving hospice/palliative care (n = 326, 50.6% female, mean age = 65.1 years, 89.3% white, all with a terminal illness with 6 months or less life expectancy). They had been randomized to standard palliative care (n = 111), client-centered care (n = 107), or DT (n = 108). Measurement: The 7-item DIS was derived from selected items in a posttest DT Patient Feedback Questionnaire. The DIS had strong internal consistency (α = 0.85). Results: The DT group mean DIS score (21.4 ± 5.0) was significantly higher than the usual care group mean score (17.7 ± 5.5; t = 5.2, df = 216, P < .001) and a client-centered intervention group mean score (17.9 ± 4.9; t = 5.2, df = 213, P < .001). Conclusion: We found that, compared to both other groups, patients who received DT reported significantly higher DIS ratings, which is consistent with the DT focus on meaning-making, preparation for death, and life completion tasks. We propose that the DIS be used as the primary outcome measure in evaluating the effects of DT.

scholarly journals Therapist- and parent-guided Internet-delivered behaviour therapy for paediatric Tourette’s Disorder: a pilot randomised controlled trial with long-term follow-up

2018 ◽  
Author(s):  
Per Andrén ◽  
Kristina Aspvall ◽  
Lorena Fernández de la Cruz ◽  
Paulina Wiktor ◽  
Sofia Romano ◽  
...  
Keyword(s):  
Young People ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Behaviour Therapy ◽  
Tourette’S Disorder ◽  
Tourette's Disorder ◽  
Tic Severity ◽  
Randomised Controlled

Objective: Behaviour therapy (BT) for Tourette’s Disorder (TD) and Persistent Motor or Vocal Tic Disorder (PTD) is rarely available. We evaluated the feasibility of adapting two existing BT protocols for TD/PTD (habit reversal training [HRT] and exposure and response prevention [ERP]) into a therapist- and parent-guided online self-help format.Design: A pilot, single-blind, parallel group randomised controlled trial.Setting: A university hospital in Sweden.Participants: Twenty-three young people with TD/PTD, aged 8-16.Interventions: Two 10-week therapist- and parent-guided Internet-delivered programmes (called BIP TIC HRT and BIP TIC ERP).Outcome: The primary outcome measure was the Yale Global Tic Severity Scale (YGTSS). Blinded evaluators rated symptoms at baseline, post-treatment, and 3-month follow-up (primary endpoint). All participants were naturalistically followed-up to 12 months after treatment.Results: Patients and parents rated the interventions as highly acceptable, credible, and satisfactory. While both interventions resulted in reduced tic-related impairment, parent-rated tic severity, and improved quality of life, only BIP TIC ERP resulted in a significant improvement on the primary outcome measure. Within-group effect sizes and responder rates were, respectively: d=1.12 and 75% for BIP TIC ERP, and d=0.50 and 55% for BIP TIC HRT. The therapeutic gains were maintained up to 12 months after the end of the treatment. Adverse events were rare in both groups. The average therapist support time was around 25 minutes per participant per week.Conclusions: Internet-delivered BT has the potential to greatly increase access to evidence-based treatment for young people with TD/PTD. Further evaluation of the efficacy and cost-effectiveness of this treatment modality is warranted.Trial registration number: NCT02864589 (ClinicalTrials.gov).Funding: The trial was supported by the Stockholm County Council (PPG project 2016-0108).

scholarly journals Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette’s disorder: a pilot randomised controlled trial with long-term follow-up

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024685 ◽  
Author(s):  
Per Andrén ◽  
Kristina Aspvall ◽  
Lorena Fernández de la Cruz ◽  
Paulina Wiktor ◽  
Sofia Romano ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Behaviour Therapy ◽  
Tic Severity ◽  
Randomised Controlled

ObjectiveBehaviour therapy (BT) for Tourette’s disorder (TD) and persistent (chronic) motor or vocal tic disorder (PTD) is rarely available. We evaluated the feasibility of adapting two existing BT protocols for TD/PTD (habit reversal training (HRT) and exposure and response prevention (ERP)) into a therapist-guided and parent-guided online self-help format.DesignA pilot, single-blind, parallel group randomised controlled trial.SettingA specialist outpatient clinic in Sweden.ParticipantsTwenty-three young people with TD/PTD, aged 8–16.InterventionsTwo 10-week therapist-guided and parent-guided internet-delivered programmes (called BIP TIC HRT and BIP TIC ERP).OutcomeThe primary outcome measure was the Yale Global Tic Severity Scale. Blinded evaluators rated symptoms at baseline, post-treatment and 3-month follow-up (primary endpoint). All participants were naturalistically followed up to 12 months after treatment.ResultsPatients and parents rated the interventions as highly acceptable, credible and satisfactory. While both interventions resulted in reduced tic-related impairment, parent-rated tic severity and improved quality of life, only BIP TIC ERP resulted in a significant improvement on the primary outcome measure. Within-group effect sizes and responder rates were, respectively: d=1.12 and 75% for BIP TIC ERP, and d=0.50 and 55% for BIP TIC HRT. The therapeutic gains were maintained up to 12 months after the end of the treatment. Adverse events were rare in both groups. The average therapist support time was around 25 min per participant per week.ConclusionsInternet-delivered BT has the potential to greatly increase access to evidence-based treatment for young people with TD/PTD. Further evaluation of the efficacy and cost-effectiveness of this treatment modality is warranted.Trial registration numberNCT02864589; Pre-results.

P07 Identifying the primary outcome measure and protocol components for a prospective feasibility study of corticosteroid regimens for CYP with JIA using consensus methods with young people, families and professionals

Rheumatology ◽  
2019 ◽  
Vol 58 (Supplement_4) ◽  
Author(s):  
Simon R. Stones ◽  
Heather Bagley ◽  
Michael W. Beresford ◽  
Ashley Jones ◽  
Flora McErlane ◽  
...  
Keyword(s):  
Young People ◽  
Outcome Measures ◽  
Feasibility Study ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Conflicts Of Interest ◽  
Rapid Onset ◽  
Primary Outcome Measure ◽  
Feasibility Trial ◽  
Consensus Methods

Abstract Background Juvenile idiopathic arthritis (JIA) is an umbrella term for seven relapsing-remitting inflammatory conditions in children and young people (CYP). Early, intensive treatment can prevent long-term damage; however, established drugs exhibit a delayed response, prompting the need for rapid-onset treatment in the form of corticosteroids. Given a lack of consensus as to which corticosteroid induction regimen should be used for CYP with JIA, a feasibility trial of different regimens is needed. The aim was to achieve consensus among CYP, families, and healthcare professionals (HCPs) about the primary outcome measures and protocol components to include in a prospective feasibility study. Methods A modified Nominal Group Technique was used to achieve consensus on the most appropriate primary outcome measure to be included in a prospective feasibility study, in addition to other protocol components such as inclusion/exclusion criteria. Fifteen participants participated in the process, including a combination of CYP with JIA, families (n = 9) and HCPs (n = 6). Results In the first vote, participants agreed that Juvenile Arthritis Disease Activity Score (JADAS) and Physician Global Assessment Score were most meaningful. During sub-group discussions, the need for a composite score which captured the voice of CYP and families was emphasised. In the second vote, JADAS and the JIA Core Set were identified as the most important. Further discussions led to the results of the third vote, agreeing JADAS as the primary outcome measure of choice being measured at 6 weeks after commencement of treatment. The majority of HCPs, CYP and families voted for all JIA sub-types to be included in a prospective feasibility study, with some queries about the inclusion of systemic JIA given its unique presentation. Participants also identified the need for more frequent data collection time points to capture the rapid onset of corticosteroid action, while CYP and families opted for accessible mechanisms for participation, such as digital follow-up strategies. Conclusion It is feasible to include CYP, families and HCPs in synthesising complex concepts to agree by consensus the design components of clinical research. The primary outcome measure for inclusion in a prospective feasibility study of corticosteroid regimens in CYP with JIA was co-prioritised, with CYP and families taking a leading role in the ultimate selection of an appropriate outcome measure and other study protocol components. Using consensus methods with CYP, families and HCPs is a systematic and rigorous way in which to select outcome measures that are both meaningful and relevant to everyone involved in the care and treatment of CYP with JIA. Conflicts of Interest The authors declare no conflicts of interest.

scholarly journals Use of an Unguided, Web-Based Distress Self-Management Program After Breast Cancer Diagnosis: Sub-Analysis of CaringGuidance Pilot Study (Preprint)

2020 ◽  
Author(s):  
Robin M Lally ◽  
Kevin Kupzyk ◽  
Steve Gallo ◽  
Donna Berry
Keyword(s):  
Breast Cancer ◽  
Pilot Study ◽  
Usual Care ◽  
Cancer Diagnosis ◽  
Intervention Group ◽  
Breast Cancer Diagnosis ◽  
Management Program ◽  
Activity Level ◽  
Self Management ◽  
Web Based

BACKGROUND Unguided, web-based psychoeducational interventions are gaining interest as a way to reach patients while reducing pressure on clinical resources. However, there has been little research on how patients with cancer use these interventions. OBJECTIVE The objective of this analysis was to evaluate how women newly diagnosed with breast cancer used the unguided web-based, psychoeducational distress self-management program CaringGuidance After Breast Cancer Diagnosis while enrolled in a pilot feasibility study. METHODS Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of CaringGuidance plus usual care versus usual care alone. Usage prompts included sets of emails sent weekly for 12 weeks; standardized congratulatory emails after every two hours of program use, and informative emails for each cognitive-behavioral exercise. Individual user activity on the site was automatically tracked by an analytics system and recorded directly in the CaringGuidance database. RESULTS Complete usage data were available for 54 subjects. Ninety-eight percent of the intervention group logged into CaringGuidance independently at least once. Thirty-eight (70%) logged in during all three months, 15 (28%) were intermittent users, and one (2%) was a non-user. Users (n=53) averaged 15.6 (SD 9.85) logins. Mean logins were greatest in month 1 (7.26, SD 4.02) and declined in months 2 (4.32, SD 3.66) and month 3 (4.02, SD 3.82). Eleven (21%) used CaringGuidance with both the frequency and activity level intended at study outset, 9 (17%) exceeded intended frequency and activity (high-high users), and 10 (19%) were below expected usage on both login frequency and activity (low-low users). Low-low users and high-high users differed significantly (<i>P</i>&lt;.001) in the total number of views and unique views of all program components. Change in depressive symptoms and the number of sessions (r=.351) and logins (r=.348) between study months 1 and 2 were significantly correlated (<i>P</i>=.018, .019). Higher baseline distress was associated with more unique views of program resources (r=.281, <i>P</i>=.043). Change in intrusive/avoidant thoughts from baseline to month 3, and the number of users’ unique exercise views were negatively correlated (r=–.319, <i>P</i>=.035) so that more unique exercise views, equated with greater decline in intrusive/avoidant thoughts from baseline to month 3. CONCLUSIONS These findings favor the hypothesis that the key ingredient is not the amount of program use, but each user’s self-selected activity within the program. More research is needed on the ideal ways to maintain use, and capture and define engagement and enactment of behaviors by people with cancer accessing unguided, self-management web-based programs.

scholarly journals Use of an Unguided, Web-Based Distress Self-Management Program After Breast Cancer Diagnosis: Sub-Analysis of CaringGuidance Pilot Study

10.2196/19734 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e19734 ◽  
Author(s):  
Robin M Lally ◽  
Kevin Kupzyk ◽  
Steve Gallo ◽  
Donna Berry
Keyword(s):  
Breast Cancer ◽  
Pilot Study ◽  
Usual Care ◽  
Cancer Diagnosis ◽  
Intervention Group ◽  
Breast Cancer Diagnosis ◽  
Management Program ◽  
Activity Level ◽  
Self Management ◽  
Web Based

Background Unguided, web-based psychoeducational interventions are gaining interest as a way to reach patients while reducing pressure on clinical resources. However, there has been little research on how patients with cancer use these interventions. Objective The objective of this analysis was to evaluate how women newly diagnosed with breast cancer used the unguided web-based, psychoeducational distress self-management program CaringGuidance After Breast Cancer Diagnosis while enrolled in a pilot feasibility study. Methods Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of CaringGuidance plus usual care versus usual care alone. Usage prompts included sets of emails sent weekly for 12 weeks; standardized congratulatory emails after every two hours of program use, and informative emails for each cognitive-behavioral exercise. Individual user activity on the site was automatically tracked by an analytics system and recorded directly in the CaringGuidance database. Results Complete usage data were available for 54 subjects. Ninety-eight percent of the intervention group logged into CaringGuidance independently at least once. Thirty-eight (70%) logged in during all three months, 15 (28%) were intermittent users, and one (2%) was a non-user. Users (n=53) averaged 15.6 (SD 9.85) logins. Mean logins were greatest in month 1 (7.26, SD 4.02) and declined in months 2 (4.32, SD 3.66) and month 3 (4.02, SD 3.82). Eleven (21%) used CaringGuidance with both the frequency and activity level intended at study outset, 9 (17%) exceeded intended frequency and activity (high-high users), and 10 (19%) were below expected usage on both login frequency and activity (low-low users). Low-low users and high-high users differed significantly (P<.001) in the total number of views and unique views of all program components. Change in depressive symptoms and the number of sessions (r=.351) and logins (r=.348) between study months 1 and 2 were significantly correlated (P=.018, .019). Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043). Change in intrusive/avoidant thoughts from baseline to month 3, and the number of users’ unique exercise views were negatively correlated (r=–.319, P=.035) so that more unique exercise views, equated with greater decline in intrusive/avoidant thoughts from baseline to month 3. Conclusions These findings favor the hypothesis that the key ingredient is not the amount of program use, but each user’s self-selected activity within the program. More research is needed on the ideal ways to maintain use, and capture and define engagement and enactment of behaviors by people with cancer accessing unguided, self-management web-based programs.

Results of the second interim assessment of rEECur, an international randomized controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma (RR-ES).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 11502-11502 ◽  
Author(s):  
Martin G. McCabe ◽  
Laura Kirton ◽  
Maria Khan ◽  
Nicola Fenwick ◽  
Uta Dirksen ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Objective Response ◽  
Randomised Trial ◽  
Primary Outcome Measure ◽  
The Other ◽  
High Dose ◽  
Interim Assessment ◽  
First Recurrence

11502 Background: Five-year survival of RR-ES is about 15%. Several chemotherapy regimens are used, but without robust evidence. rEECur, the first randomised controlled trial in this setting, is defining a standard of care, balancing efficacy and toxicity. Methods: Patients aged 4 to 50 with RR-ES and fit to receive chemotherapy were randomised between topotecan & cyclophosphamide (TC), irinotecan & temolozomide (IT), gemcitabine & docetaxel (GD) or high-dose ifosfamide (IFOS). Primary outcome measure was objective response (OR) after 4 cycles by RECIST 1.1. Secondary outcomes included PFS, OS and toxicity. A probability-based Bayesian approach was used with multiple pairwise comparisons. At the first interim analysis patients allocated to GD had worse OR and PFS than the other arms and accrual to the GD arm was halted. The second interim assessment was planned to determine which arm should be closed when at least 75 evaluable patients had been recruited to the remaining arms and evaluated for the primary outcome measure. Results: 366 patients (87% RECIST-evaluable), recruited between 18/12/14 and 17/12/19, were randomised to TC (n=124), IT (118), GD (72) and IFOS (53). Median age was 20 years (range 4-49). Patients had: refractory disease (19%), first recurrence (66%), > first recurrence (14%). Initial disease site was bone in (66%). Sites of progression were: primary site only (16%) pleuropulmonary only (32%), other metastatic (52%). At median follow up of 9.2 months, outcome in the IT arm was: response rate 20%, median PFS 4.7 months (95% CI: 3.4 to 5.7), median OS 13.9 months (95% CI: 10.6 to 18.1). The table shows, for each pairwise comparison of IT with the other open arms (randomly labelled A and B to maintain blinding), the probabilities that OR, PFS and OS were better for X than for each other arm (RR = risk ratio, HR = hazard ratio). For OR, PFS and OS, all comparisons favoured arms A and B. The main grade 3/4 adverse events (% patients with an event) for IT (left hand values) compared with A and B pooled were: vomiting (6% v 1%), nausea (6% v 0%), diarrhoea (17% v 0%), fatigue (3% v 1%) and febrile neutropenia (3% v 24%). Conclusions: The first randomised trial in RR-ES has shown that IT, used as a control arm in planned and ongoing randomised phase II studies in RR-ES, is less effective than A and B in achieving tumour shrinkage or prolonging PFS and OS. The remaining two arms are continuing to recruit patients. Clinical trial information: ISRCTN36453794 . [Table: see text]

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