Solid TumorIMPACTNCT02505165
Illness Management and Parental Adjustment to Cancer Treatment
A study testing IMPACT and ESO in people with Solid Tumor and Leukemia, run by Children's Hospital Medical Center, Cincinnati at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Solid Tumor, Leukemia, Lymphoma
- What is being tested?
- IMPACT and ESO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Nov 2015to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Dayton Children's Hospital
Dayton, Ohio, 45404
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Clinic-Based Interdisciplinary Intervention for Parents of Children With Cancer
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.
Read the detailed description
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.
- Conditions
- Solid Tumor, Leukemia, Lymphoma, Brain Tumor
- Being tested
- IMPACT, ESO
- Keywords
- Intervention, Illness Uncertainty, Childhood Cancer, Solid Tumor, Leukemia, Lymphoma, Brain Tumor, Randomized clinical trial, Parental uncertainty management intervention, Parent, Oncology, Pediatric
- Medical subject headings
- Leukemia, Lymphoma, Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACTBehavioural
Also called Parent Uncertainty Management Intervention
- 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.
ESOOther
Also called Education/Support Only
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: IMPACT |
| 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. Receives: Other: ESO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90.
indicator of global psychological symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: Change in GSI score from baseline to 12-month post-intervention
Secondary outcomes (4)
Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)
Measure of caregiver post-traumatic stress symptoms
Measured: 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)
Measure of caregiver post-traumatic stress symptoms
Measured: 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
Measured: 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
Measured: Change in IES-R total score score from baseline to 12-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study start19 Nov 2015
- Primary completion22 Apr 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma, Oklahoma State University, Dayton Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Ahna LH Pai, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505165
- Sponsor's protocol ID
- NR014248
- Acronym
- IMPACT
- Status last verified
- Apr 2022
- First submitted
- 17 Jun 2015
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 28177514Sharkey 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.
PubMed 32196095Morrison 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.
PubMed 26836990Marsolo 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.
PubMed 28652227Basile 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.
PubMed 34350968Nebeker 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.
PubMed 28659258
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinic-Based Interdisciplinary Intervention for Parents of Children With Cancer
- ClinicalTrials.gov ID
- NCT02505165
- Acronym / sponsor ID
- IMPACT / NR014248
- Conditions
- Solid Tumor, Leukemia, Lymphoma, Brain Tumor
- Keywords
- Intervention, Illness Uncertainty, Childhood Cancer, Solid Tumor, Leukemia, Lymphoma, Brain Tumor, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Oklahoma, Oklahoma State University, Dayton Children's Hospital
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Uncertainty Intervention | Experimental | Behavioral: IMPACTA 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 | Other: ESOSessions 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. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPACTAlso: Parent Uncertainty Management Intervention• 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. | Behavioural | Parent Uncertainty Intervention |
| ESOAlso: Education/Support OnlyThis 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. | Other | Education/Support Only |
Primary outcome
Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90.
Time frame: Change in (global severity index) GSI score from baseline to 1-week post-intervention
indicator of global psychological symptoms
Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90.
Time frame: Change in GSI score from baseline to 3-month post-intervention
indicator of global psychological symptoms
Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90.
Time frame: Change in GSI score from baseline to 6-month post-intervention
indicator of global psychological symptoms
Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90.
Time frame: Change in GSI score from baseline to 12-month post-intervention
indicator of global psychological symptoms
4 secondary outcomes
Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change in IES-R total score score from baseline to 12-month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Background: PubMed 28177514Szulczewski 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.
- Background: PubMed 32196095Sharkey 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.
- Results publication: PubMed 26836990Morrison 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.
- Results publication: PubMed 28652227Marsolo 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.
- Results publication: PubMed 34350968Basile 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.
- Derived from this study: PubMed 28659258Nebeker 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahna LH Pai, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT and ESO in people with Solid Tumor and Leukemia, run by Children's Hospital Medical Center, Cincinnati at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90. (time frame: Change in (global severity index) GSI score from baseline to 1-week post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505165, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.