Clinical trial · Interventional
Illness Management and Parental Adjustment to Cancer Treatment
A Clinic-Based Interdisciplinary Intervention for Parents of Children With Cancer
NCT02505165CI-TRIAL-00057761IMPACTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ESO | Other | — | UNRESOLVED |
| IMPACT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Parent Uncertainty Intervention
- description
- 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.
- interventionNames
- Behavioral: IMPACT
- type
- OTHER
- label
- Education/Support Only
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The child has been diagnosed with leukemia or lymphoma, malignant solid tumor, or malignant brain tumor * The child is being treated for cancer and returning to the medical center (CCHMC or OUHSC). * The child is 18 years of age or younger * Recruitment occurs within 2-12 weeks post diagnosis * The parent is responsible for care and is willing to give consent and participate * The child is willing to give assent or consent and participate (only for children 8 years old and older) * The parent gives patient permission to participate. * Parent is fluent in English Exclusion Criteria: * The child is experiencing an imminent medical crisis necessitating significant medical intervention * The child with cancer is determined to be in the terminal phase of illness and/or is receiving end of life care * The diagnosis is determined to be a relapse or a second malignancy * The parent is currently being treated for a serious psychiatric disorder, or, evidences mental retardation * The parent is younger than 18 years of age * The parent is not English speaking * The parent is unwilling to give written permission for child participation * If the patient's treatment visit schedule is too infrequent to meet the study visit timeline requirements
References
Publications (6)
- BACKGROUNDSzulczewski 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. PMID 28177514
- BACKGROUNDSharkey 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. PMID 32196095
- RESULTMorrison 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. PMID 26836990
- RESULTMarsolo 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. PMID 28652227
- RESULTBasile 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. PMID 34350968
- DERIVEDNebeker 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. PMID 28659258