Trial · NCT07882927
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean change in patient stigma score from baseline to six months as reported by the KidsCanSHINE tool | Baseline and at 6 months (+/- 1 month) | KidsCanSHINE survey tool inquires about the experience of stigma in multiple dimensions and about related patient reported quality of life metrics, information on their diagnosis and treatment course, perceptions of care quality, and demographic information (sex, age, school information, treating institution), This tool uses a 5-point Likert scale and stigma will be assessed across 3 domains. The scale has a range from 1 to 5. Selecting 1 indicates "Almost never" and selecting 5 indicates "Almost always." Higher scores indicate higher levels of stigma. |
| Primary | Mean change in caregiver stigma score from baseline to six months as reported by the CaregiversCanSHINE tool | Baseline and at 6 months (+/- 1 month) | The CaregiversCanSHINE survey tool inquires about the experience of stigma in multiple dimensions and about information related to being a caregiver of a child with cancer, including reported quality of life metrics, information on their child's diagnosis and treatment course, perceptions of care quality, and demographic information (sex, age at diagnosis, relationship to the patient, etc). This tool uses a 5-point Likert scale and stigma will be assessed across 3 domains. The scale has a range from 1 to 5. Selecting 1 indicates "Almost never" and selecting 5 indicates "Almost always." Higher scores indicate higher levels of stigma. |
| Primary | Changes in stigma score after intervention as reported by the KidsCanSHINE tool | Baseline, Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) | The KidsCanSHINE survey tool inquires about the experience of stigma in multiple dimensions. This tool uses a 5-point Likert scale and stigma will be assessed across 3 domains. The scale has a range from 1 to 5. Selecting 1 indicates "Almost never" and selecting 5 indicates "Almost always." Higher scores indicate higher levels of stigma. Individuals will complete the assessments at baseline, immediately after the intervention, and at conclusion of the pilot (six months after intervention). |
| Primary | Changes in stigma score after intervention as reported by the CaregiversCanSHINE tool | Baseline, Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) | The CaregiversCanSHINE survey tool inquires about the experience of stigma in multiple dimensions. This tool uses a 5-point Likert scale and stigma will be assessed across 3 domains. The scale has a range from 1 to 5. Selecting 1 indicates "Almost never" and selecting 5 indicates "Almost always." Higher scores indicate higher levels of stigma. Individuals will complete the assessment at baseline, immediately after the intervention, and at conclusion of the pilot (six months after intervention). |
| Primary | Characterization of Internalized Stigma as reported by the KidsCanSHINE tool | At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) | The KidsCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Internalized Stigma. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Internalized Stigma score as reported by patients. |
| Primary | Characterization of Perceived Stigma as reported by the KidsCanSHINE tool | At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) | The KidsCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Perceived Stigma. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Perceived Stigma score as reported by patients. |
| Primary | Characterization of Discrimination Experiences as reported by the KidsCanSHINE tool | At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) | The KidsCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Discrimination Experiences. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Discrimination Experiences score as reported by patients. |
| Primary | Characterization of Internalized Stigma as reported by the CaregiversCanSHINE tool | At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) | The CaregiversCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Internalized Stigma. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Internalized Stigma score as reported by caregivers. |
| Primary | Characterization of Perceived Stigma as reported by the CaregiversCanSHINE tool | At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) | The CaregiversCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Perceived Stigma. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Perceived Stigma score as reported by caregivers. |
| Primary | Characterization of Discrimination Experiences as reported by the CaregiversCanSHINE tool | At baseline (as appropriate), post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) | The CaregiversCanSHINE survey tool inquiries about the experience of stigma in multiple dimensions, including Discrimination Experiences. Each item in this domain is scored on a Likert Scale, from 1 (Almost Never) to 5 (Almost Always). Investigators will evaluate the average Discrimination Experiences score as reported by caregivers. |
| Primary | Feasibility of Intervention | Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) | Participants and clinicians who complete the intervention will be asked to complete the Feasibility of Intervention Measure (FIM). The FIM is used to assess how feasible it is to implement a specific intervention. The FIM measure includes four itemized responses that are scored from one to five (1=Completely disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Completely agree). Higher scores indicate greater perceived feasibility of the intervention. |
| Primary | Acceptability of Intervention | Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) | Participants and clinicians who complete the intervention will be asked to complete the Acceptability of Intervention Measure (AIM). The AIM is a four-item scale used to assess the acceptability of an intervention. It includes four itemized responses that are scored from one to five (1=Completely disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Completely agree). Higher scores indicating greater acceptability. |
| Primary | Appropriateness of Intervention | Post intervention (intervention will last 4-6 weeks), and six months after intervention (+/- 1 month) | Participants and clinicians who complete the intervention will be asked to complete the Appropriateness Measure (IAM). The Intervention Appropriateness Measure (IAM) is a four-item scale used to assess the appropriateness of interventions by capturing individual perspectives on the alignment of the intervention with professional values and perceived efficacy in meeting patient needs. Each item is rated on a 5-point Likert scale (1=Completely disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Completely agree). A higher score on the IAM indicates a stronger perception that the intervention is appropriate for the given situation and context. |
| Primary | Qualitative Interviews | Within 4 weeks of the final component of the intervention | The investigators will conduct a qualitative assessment on experiences of the intervention and stigma in pediatric cancer. Audio recordings of qualitative data will be translated and transcribed into English. Transcripts will be de-identified, segmented, and uploaded to MAXQDA for analysis. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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