scholarly journals Suggestions from adolescents, young adults, and parents for improving informed consent in phase 1 pediatric oncology trials

Cancer ◽  
2013 ◽  
Vol 119 (23) ◽  
pp. 4154-4161 ◽  
Author(s):  
Justin N. Baker ◽  
Angela C. Leek ◽  
Halle Showalter Salas ◽  
Dennis Drotar ◽  
Robert Noll ◽  
...  
Keyword(s):  
Young Adults ◽  
Informed Consent ◽  
Pediatric Oncology ◽  
Phase 1

scholarly journals Practical communication guidance to improve phase 1 informed consent conversations and decision-making in pediatric oncology

Cancer ◽  
2015 ◽  
Vol 121 (14) ◽  
pp. 2439-2448 ◽  
Author(s):  
Liza-Marie Johnson ◽  
Angela C. Leek ◽  
Dennis Drotar ◽  
Robert B. Noll ◽  
Susan R. Rheingold ◽  
...  
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
Pediatric Oncology ◽  
Phase 1

scholarly journals Does the guided online cognitive behavioral therapy for insomnia “i-Sleep youth” improve sleep of adolescents and young adults with insomnia after childhood cancer? (MICADO-study): study protocol of a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shosha H. M. Peersmann ◽  
Annemieke van Straten ◽  
Gertjan J. L. Kaspers ◽  
Adriana Thano ◽  
Esther van den Bergh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Young Adults ◽  
Cognitive Behavioral Therapy ◽  
Childhood Cancer ◽  
Pediatric Oncology ◽  
Behavioral Therapy ◽  
Cognitive Behavioral ◽  
Adolescents And Young Adults ◽  
Randomized Controlled

Abstract Background Adolescents and young adults who had childhood cancer are at increased risk for insomnia, due to being critically ill during an important phase of their life for the development of good sleep habits. Insomnia is disabling and prevalent after childhood cancer (26–29%) and negatively impacts quality of life, fatigue, pain, and general functioning and is often associated with other (mental) health problems. Insomnia and a history of childhood cancer both increase the risk of adverse health outcomes, posing a double burden for adolescents who had childhood cancer. The first-line treatment for insomnia is cognitive behavioral therapy for insomnia (CBT-I). However, access to this type of care is often limited. The guided online CBT-I treatment “i-Sleep” has been developed to facilitate access via online care. i-Sleep is shown effective in adult (breast cancer) patients, but it is unknown if iCBT-I is effective in pediatric oncology. Methods/design We developed a youth version of i-Sleep. Our aim is to evaluate its effectiveness in a national randomized-controlled clinical trial comparing iCBT-I to a waiting-list control condition at 3 and 6 months (n = 70). The intervention group will be also assessed at 12 months to see whether the post-test effects are maintained. Adolescents and young adults aged 12–30 years with insomnia, diagnosed with (childhood) cancer, currently at least 6 months since their last cancer treatment will be eligible. Outcomes include sleep efficiency (actigraphic), insomnia severity (self-report), sleep and circadian activity rhythm parameters, fatigue, health-related quality of life, perceived cognitive functioning, chronic distress, depressive and anxiety symptoms, and intervention acceptability. Discussion Insomnia is prevalent in the pediatric oncology population posing a double health burden for adolescents and young adults who had childhood cancer. If guided iCBT-I is effective, guidelines for insomnia can be installed to treat insomnia and potentially improve quality of life and the health of adolescents and young adults who had childhood cancer. Trial registration NL7220 (NTR7419; Netherlands Trial register). Registered on 2 August 2018

Does the guided online cognitive behavioral therapy for insomnia “i-Sleep youth” improve sleep of adolescents and young adults with insomnia after childhood cancer? (MICADO-study): Study protocol of a randomized-controlled trial

2021 ◽  
Author(s):  
Shosha Peersmann ◽  
Annemieke van Straten ◽  
Gertjan Kaspers ◽  
Adriana Thano ◽  
Esther van den Bergh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Young Adults ◽  
Cognitive Behavioral Therapy ◽  
Childhood Cancer ◽  
Pediatric Oncology ◽  
Behavioral Therapy ◽  
Cognitive Behavioral ◽  
Adolescents And Young Adults ◽  
Randomized Controlled

Abstract Background: Adolescents and young adults who had childhood cancer are at increased risk for insomnia, due to being critically ill during an important phase of their life for the development of good sleep habits. Insomnia is disabling and prevalent after childhood cancer (26-29%) and negatively impacts quality of life, fatigue, pain and general functioning and is often associated with other (mental) health problems. Insomnia and a history of childhood cancer both increase the risk of adverse health outcomes, posing a double burden for adolescents who had childhood cancer. The first-line treatment for insomnia is cognitive behavioral therapy for insomnia (CBT-I). However, access to this type of care is often limited. The guided online CBT-I treatment “i-Sleep” has been developed to facilitate access via online care. i-Sleep is shown effective in adult (breast cancer) patients, but it is unknown if iCBT-I is effective in pediatric oncology. Methods/design: We developed a youth version of i-Sleep. Our aim is to evaluate its effectiveness in a national randomized-controlled clinical trial comparing iCBT-I to a waiting-list control condition at 3 and 6 months ( n =70). The intervention group will be also assessed at 12 months to see whether the post-test effects are maintained. Adolescents and young adults aged 12-30 years with insomnia, diagnosed with (childhood) cancer, currently at least 6 months since their last cancer treatment will be eligible. Outcomes include sleep efficiency (actigraphic), insomnia severity (self-report), sleep and circadian activity rhythm parameters, fatigue, health-related quality of life, perceived cognitive functioning, chronic distress, depressive- and anxiety symptoms and intervention acceptability. Discussion: Insomnia is prevalent in the pediatric oncology population posing a double health burden for adolescents and young adults who had childhood cancer. If guided iCBT-I is effective, guidelines for insomnia can be installed to treat insomnia and potentially improve quality of life and the health of adolescents and young adults who had childhood cancer. Trial registration: NL7220 (NTR7419; Netherlands Trial register), registered 02-August-2018

scholarly journals Parental perceptions of the informed consent process in pediatric oncology clinical trials

2013 ◽  
Vol 3 (11) ◽  
Author(s):  
Yvonne D Hastings ◽  
Natalie K Bradford ◽  
Liane R Lockwood ◽  
Robert S Ware ◽  
Jeanine Young
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Pediatric Oncology ◽  
Parental Perceptions ◽  
Informed Consent Process ◽  
Consent Process ◽  
Oncology Clinical Trials

scholarly journals An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021613 ◽  
Author(s):  
Muhammed Olanrewaju Afolabi ◽  
Stuart Rennie ◽  
Denise Dion Hallfors ◽  
Tracy Kline ◽  
Susannah Zeitz ◽  
...  
Keyword(s):  
Young Adults ◽  
Informed Consent ◽  
Content Validity ◽  
Temporal Stability ◽  
Study Groups ◽  
Research Setting ◽  
Western Kenya ◽  
Validated Questionnaire ◽  
Item Level ◽  
Study Participants

ObjectiveTo adapt and validate a questionnaire originally developed in a research setting for assessment of comprehension of consent information in a different cultural and linguistic research setting.DesignThe adaptation process involved development and customisation of a questionnaire for each of the three study groups, modelled closely on the previously validated questionnaire. The three adapted draft questionnaires were further reviewed by two bioethicists and the developer of the original questionnaire for face and content validity. The revised questionnaire was subsequently programmed into an audio computerised format, with translations and back translations in three widely spoken languages by the study participants: Luo, Swahili and English.SettingThe questionnaire was validated among adolescents, their parents and young adults living in Siaya County, a rural region of western Kenya.ParticipantsTwenty-five-item adapted questionnaires consisting of close-ended, multiple-choice and open-ended questions were administered to 235 participants consisting of 107 adolescents, 92 parents and 36 young adults. Test-retest was conducted 2–4 weeks after first questionnaire administration among 74 adolescents, young adults and parents.Outcome measurePrimary outcome measures included ceiling/floor analysis to identify questions with extremes in responses and item-level correlation to determine the test-retest relationships. Given the data format, tetrachoric correlations were conducted for dichotomous items and polychoric correlations for ordinal items. The qualitative validation assessment included face and content validity evaluation of the adapted instrument by technical experts.ResultsCeiling/floor analysis showed eight question items for which >80% of one or more groups responded correctly, while for nine questions, including all seven open-ended questions,<20% responded correctly. Majority of the question items had moderate to strong test-retest correlation estimates indicating temporal stability.ConclusionsOur study demonstrates that cross-cultural adaptation and validation of an informed consent comprehension questionnaire is feasible. However, further research is needed to develop a tool which can estimate a quantifiable threshold of comprehension thereby serving as an objective indicator of the need for interventions to improve comprehension.

Decision making and informed consent among participants in novel phase 1 trial designs.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e21548-e21548
Author(s):  
Katherine Elizabeth Reeder-Hayes ◽  
Megan Roberts ◽  
Elizabeth Claire Dees
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
Phase 1 ◽  
Phase 1 Trial

Adherence to clinical practice guidelines for the prevention of acute chemotherapy-induced nausea and vomiting in children, adolescents, and young adults with cancer receiving their first cycle of highly emetogenic chemotherapy.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 19-19
Author(s):  
Melissa Beauchemin ◽  
Chunhua Weng ◽  
L. Lee Dupuis ◽  
Lillian Sung ◽  
Dawn L. Hershman ◽  
...  
Keyword(s):  
Young Adults ◽  
Pediatric Oncology ◽  
Clinical Setting ◽  
Chemotherapy Regimen ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Adolescents And Young Adults ◽  
Cancer Type ◽  
Electronic Health Record Data ◽  
Highly Emetogenic Chemotherapy

19 Background: Prescribing guideline-recommended anti-emetics for the prevention of chemotherapy-induced nausea and vomiting (CINV) is an effective strategy to prevent a common treatment-related adverse effect in children, adolescents and young adults (AYAs) with cancer that impacts quality of life. The rate of guideline-concordant care (GCC) is not well-understood. Methods: Using electronic health record data Columbia University Irving Medical Center from a 3-year period, we conducted a retrospective single-institution cohort study to investigate how often children and AYAs (age 26 or less) receive GCC to prevent CINV prior to the first administration of highly-emetogenic chemotherapy. We defined GCC from the Pediatric Oncology Group of Ontario guideline for patients < 18 years and the American Society of Clinical Oncology guideline for those ≥ 18 years. Independent variables included: sex, age, insurance status, race, ethnicity, cancer type, chemotherapy regimen, clinical setting (adult or pediatric oncology), and patient location (inpatient or outpatient). Predictors of GCC were determined using multiple logistic regression. Results: Of 91 included patients, 39 (43%) received GCC. Those treated in adult oncology setting (OR 7.5, 95% CI: 2.7–20.7), receiving cisplatin-based chemotherapy (OR 3.5, CI: 1.4–8.5), or with commercial insurance (OR 2.7, CI: 1.1–6.3) were more likely to receive GCC. In multivariable analysis, patients treated in adult oncology had 6.4 higher odds (CI: 2.1–19.1, p<.001) and those receiving cisplatin 4.6 higher odds (1.6–13, p<.01) of GCC. Conclusions: Clinical setting and chemotherapy regimen independently predicted GCC for prevention of CINV in children and AYAs receiving highly-emetogenic chemotherapy. These findings can inform current efforts to optimize implementation strategies for supportive care guidelines by focusing on specific provider- and patient-level factors.

1198 Treatment of localized Ewing's sarcoma in young adults. A study of the French society of pediatric oncology

1995 ◽  
Vol 31 ◽  
pp. S250
Author(s):  
O. Oberlin ◽  
N.B. Bui ◽  
N. Dohollou ◽  
M.C. Demaille ◽  
M. Brunat-Mentigny ◽  
...  
Keyword(s):  
Young Adults ◽  
Pediatric Oncology ◽  
Ewing’S Sarcoma ◽  
Ewing's Sarcoma ◽  
French Society
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