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| Name | Class |
|---|---|
| University of Oklahoma | OTHER |
| Oklahoma State University | OTHER |
| Dayton Children's Hospital | OTHER |
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The purpose of this study is to test the efficacy of a clinic-based intervention designed to reduce illness uncertainty for parents of children who have been recently diagnosed with cancer.
The proposed trial will test the efficacy of the parent-focused clinic-based Parent Uncertainty Management Intervention (PUMI) to improve the outcomes of children newly diagnosed with cancer and their parents. Participants will be randomly assigned to receive equivalent doses of either the PUMI or an Education/Support (ESO) group. Theoretically driven by Mishel's model of illness uncertainty, the PUMI will teach parents about uncertainty prevention and management through the use of medically-specific communication, information management, and problem-solving skills via in-clinic sessions and an online portal. Parents and children will complete measures online at baseline, 1-week, and 3-, 6-, and 12-month follow-ups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent Uncertainty Intervention | Experimental | A pediatric cancer-specific, clinic based, six-module interdisciplinary uncertainty intervention. Modules one through three target uncertainty prevention. Modules four through six target uncertainty responses for situations in which uncertainty cannot be prevented or avoided. |
|
| Education/Support Only | Other | Sessions in this condition aim to provide education on cancer etiology, medical treatments, side effects, potential short- and long-term effects of treatment and resources that are often helpful to parents of children with cancer. Information presented will be based upon, "Young People with Cancer: A Handbook for Parents", a parent resource developed by the National Cancer Institute. Parents will also be provided with relevant educational brochures from COG. Each session will also include a structured set of questions that will facilitate discussion. All ESO interventionists will be trained in non-directive approaches including reflective listening. Content provided in the ESO sessions will offer valuable information to parents without providing the specific skills of the IMPACT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMPACT | Behavioral | • The intervention is 6 sessions lasting approximately 45 minutes reviewing ways to help prevent and respond to illness uncertainty. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90. | indicator of global psychological symptoms | Change in (global severity index) GSI score from baseline to 1-week post-intervention |
| Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90. | indicator of global psychological symptoms | Change in GSI score from baseline to 3-month post-intervention |
| Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90. | indicator of global psychological symptoms | Change in GSI score from baseline to 6-month post-intervention |
| Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90. | indicator of global psychological symptoms | Change in GSI score from baseline to 12-month post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R) | Measure of caregiver post-traumatic stress symptoms | Change in IES-R total score score from baseline to 1-week post-intervention |
| Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahna LH Pai, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States | ||
| Dayton Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28177514 | Background | Szulczewski L, Mullins LL, Bidwell SL, Eddington AR, Pai ALH. Meta-Analysis: Caregiver and Youth Uncertainty in Pediatric Chronic Illness. J Pediatr Psychol. 2017 May 1;42(4):395-421. doi: 10.1093/jpepsy/jsw097. | |
| 32196095 | Background | Sharkey CM, Schepers SA, Drake S, Pai ALH, Mullins LL, Grootenhuis MA. Psychosocial Risk Profiles Among American and Dutch Families Affected by Pediatric Cancer. J Pediatr Psychol. 2020 May 1;45(4):463-473. doi: 10.1093/jpepsy/jsaa012. |
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Due to the sensitive nature of the measures that provided information on the participants psychologically symptoms the final dataset will be stripped of identifiers prior to any release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics due the relatively rare pediatric oncological diagnoses of the children in the study. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using the highest standards of practice; and (3) a commitment to destroying or returning the data after analyses are completed.
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D001932 | Brain Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
|
| ESO | Other | This control is 6 sessions lasting approximately 45 minutes providing education on cancer etiology, medical treatments, side effects, potential short- and long-term effects of treatment and resources that are often helpful to parents of children with cancer. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist. |
|
|
Measure of caregiver post-traumatic stress symptoms |
| Change in IES-R total score score from baseline to 3-month post-intervention |
| Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R) | Measure of caregiver post-traumatic stress symptoms | Change in IES-R total score score from baseline to 6-month post-intervention |
| Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R) | Measure of caregiver post-traumatic stress symptoms | Change in IES-R total score score from baseline to 12-month post-intervention |
| Dayton |
| Ohio |
| 45404 |
| United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| 26836990 | Result | Morrison CF, Szulczewski L, Strahlendorf LF, Lane JB, Mullins LL, Pai AL. Designing Technology to Address Parent Uncertainty in Childhood Cancer. ANS Adv Nurs Sci. 2016 Jan-Mar;39(1):15-25. doi: 10.1097/ANS.0000000000000100. |
| 28652227 | Result | Marsolo K, Shuman W, Nix J, Morrison CF, Mullins LL, Pai AL. Reducing Parental Uncertainty Around Childhood Cancer: Implementation Decisions and Design Trade-Offs in Developing an Electronic Health Record-Linked Mobile App. JMIR Res Protoc. 2017 Jun 26;6(6):e122. doi: 10.2196/resprot.7523. |
| 34350968 | Result | Basile NL, Chardon ML, Peugh J, Edwards CS, Szulczewski L, Morrison CF, Nagarajan R, El-Sheikh A, Chaney JM, Pai ALH, Mullins LL. Relationship Between Caregiver Uncertainty, Problem-Solving, and Psychological Adjustment in Pediatric Cancer. J Pediatr Psychol. 2021 Oct 18;46(10):1258-1266. doi: 10.1093/jpepsy/jsab065. |
| 28659258 | Derived | Nebeker C, Murray K, Holub C, Haughton J, Arredondo EM. Acceptance of Mobile Health in Communities Underrepresented in Biomedical Research: Barriers and Ethical Considerations for Scientists. JMIR Mhealth Uhealth. 2017 Jun 28;5(6):e87. doi: 10.2196/mhealth.6494. |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |