DECISIVE Tool Pilot Trial
NCT07933484, Not applicable, Not yet recruiting, Yale University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | DECISIVE Tool Pilot Trial | ClinicalTrials.gov |
| NCT number | NCT07933484 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Yale University | ClinicalTrials.gov |
| Conditions | Peritoneal Cancer | ClinicalTrials.gov |
| Interventions | DECISIVE | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Reach | From screening to enrollment, approximately one week | Percentage of eligible participants that were contacted, enrolled, and randomized to the tool arm who ultimately accessed the tool. | ClinicalTrials.gov |
| Primary | Feasibility- screen-to-enrollment ratio milestone | Pre-operative (baseline) and 6 weeks post-operative | Achieving screen-to-enrollment ratio of \>30% | ClinicalTrials.gov |
| Primary | Feasibility- successful recruitment milestone | Pre-operative (baseline) and 6 weeks post-operative | Achieving successful recruitment of at least 20 participants | ClinicalTrials.gov |
| Primary | Feasibility- complete follow up milestone | Pre-operative (baseline) and 6 weeks post-operative | Achieving 90% of participants complete follow-up interviews and surveys | ClinicalTrials.gov |
| Primary | Mean score Acceptability of Intervention Measure (AIM) | 6 weeks and 6 months post-operative | The Acceptability of Intervention Measure (AIM) is a brief self-report measures designed to assess the extent to which an intervention is acceptable. Scores range from 8 to 40 with higher scores indicating greater acceptability (better outcome = high acceptability). | ClinicalTrials.gov |
| Primary | Was It Worth It scale | 6 weeks and 6 months post-operative | 3-item questionnaire used in medical and oncology research to measure a patient's perception of whether a treatment's benefits justified its side effects and burdens. Responses to each question: Yes, No or Uncertain. | ClinicalTrials.gov |
| Primary | Participant satisfaction | 6 weeks and 6 months post-operative | Indicators of satisfaction or perceived usefulness of tool in thematic analysis of interview transcripts. | ClinicalTrials.gov |
| Secondary | Percentage of participants that achieve Informational satisfaction | Baseline to 6 months post-operative | Informational satisfaction defined as participants' perceived satisfaction with information received throughout their consultation for cytoreductive surgery using De novo Likert scale instrument developed for the study | ClinicalTrials.gov |
| Secondary | Participants Informational satisfaction- thematic interviews | Baseline to 6 months post-operative | Informational satisfaction defined as participants' perceived satisfaction with information received throughout their consultation for cytoreductive surgery via thematic analysis of interview transcripts | ClinicalTrials.gov |
| Secondary | Mean score Decision Regret Scale | Baseline to 6 months post-operative | 5-item ool developed to measure distress or remorse after making a decision, most commonly in health care. Raw scores transformed to a standard 0 to 100 with higher scores indicating more regret. | ClinicalTrials.gov |
| Secondary | Decision regret- thematic interviews | Baseline to 6 months post-operative | Regret about final decision to undergo or not undergo cytoreductive surgery via thematic analysis of interview transcripts | ClinicalTrials.gov |
| Secondary | Mean score Shared Decision Making (SDM) Process Survey | Baseline to 6 months post-operative | Total scores 0-4 where higher scores indicate more shared decision making. | ClinicalTrials.gov |
| Secondary | Shared decision-making - thematic interviews | Baseline to 6 months post-operative | Degree to which clinical consultation utilized shared decision-making principles via thematic analysis of interview transcripts. | ClinicalTrials.gov |
| Secondary | Mean score Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) | Baseline to 6 months post-operative | 7-item patient-reported quality-of-life measure designed for oncology research and clinical practice. Total score range 0 to 28 with higher scores indicating a better quality of life. | ClinicalTrials.gov |
| Secondary | Quality of life - thematic interviews | Baseline to 6 months post-operative | Participant-reported perception of quality of life via thematic analysis of interview transcripts. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)