ClinicalTrials.gg
Not yet recruitingNCT07933484DECISIVEUpdated Nov 12, 2026

DECISIVE Tool Pilot Trial

An interventional study of DECISIVE in Peritoneal Cancer, sponsored by Yale University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Yale University · Not applicable, Interventional, and Supportive care

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the provided educational material and decision-making support related to cytoreductive surgery.

Read the detailed description

Participants will be given either standard of care or a website-based educational tool regarding cytoreductive surgery and complete an online pre-operative survey, 6 week follow up Zoom interview and two online post-operative surveys at 6 weeks and 6 months.

02

Conditions studied

  • Peritoneal Cancer

Keywords

  • Cytoreductive surgery
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,771 studies on the registry; 295 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Scheduled for an upcoming new-patient consultation through the Yale PSM Program for evaluation of cytoreductive surgery
  • Has not yet made a final treatment decision regarding cytoreductive surgery at the time of recruitment
  • Able to provide
  • Able to receive electronic communication (email or text) to access the DECISIVE tool
  • English-speaking (for this version of DECISIVE)

Exclusion criteria

Exclusion Criteria:

  • Previously completed the DECISIVE tool as part of earlier study stages
  • Significant cognitive impairment precluding
  • No upcoming evaluation for cytoreductive surgery through the Yale PSM Program
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    DECISIVE educational/decision-support tool

    Participants will receive the DECISIVE decision-support tool at their initial consultation for cytoreductive surgery.

    Behavioral: DECISIVE

  • No intervention
    Standard of care

    Participants given standard educational materials alone.

Interventions

  • BehavioralDECISIVE

    Decision-support tool received at initial consultation for cytoreductive surgery.

06

What researchers measure

Primary outcomes

  1. Reach

    Percentage of eligible participants that were contacted, enrolled, and randomized to the tool arm who ultimately accessed the tool.

    Time frame: From screening to enrollment, approximately one week

  2. Feasibility- screen-to-enrollment ratio milestone

    Achieving screen-to-enrollment ratio of \>30%

    Time frame: Pre-operative (baseline) and 6 weeks post-operative

  3. Feasibility- successful recruitment milestone

    Achieving successful recruitment of at least 20 participants

    Time frame: Pre-operative (baseline) and 6 weeks post-operative

  4. Feasibility- complete follow up milestone

    Achieving 90% of participants complete follow-up interviews and surveys

    Time frame: Pre-operative (baseline) and 6 weeks post-operative

  5. Mean score Acceptability of Intervention Measure (AIM)

    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).

    Time frame: 6 weeks and 6 months post-operative

  6. Was It Worth It scale

    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.

    Time frame: 6 weeks and 6 months post-operative

  7. Participant satisfaction

    Indicators of satisfaction or perceived usefulness of tool in thematic analysis of interview transcripts.

    Time frame: 6 weeks and 6 months post-operative

Secondary outcomes

  1. Percentage of participants that achieve Informational satisfaction

    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

    Time frame: Baseline to 6 months post-operative

  2. Participants Informational satisfaction- thematic interviews

    Informational satisfaction defined as participants' perceived satisfaction with information received throughout their consultation for cytoreductive surgery via thematic analysis of interview transcripts

    Time frame: Baseline to 6 months post-operative

  3. Mean score Decision Regret Scale

    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.

    Time frame: Baseline to 6 months post-operative

  4. Decision regret- thematic interviews

    Regret about final decision to undergo or not undergo cytoreductive surgery via thematic analysis of interview transcripts

    Time frame: Baseline to 6 months post-operative

  5. Mean score Shared Decision Making (SDM) Process Survey

    Total scores 0-4 where higher scores indicate more shared decision making.

    Time frame: Baseline to 6 months post-operative

  6. Shared decision-making - thematic interviews

    Degree to which clinical consultation utilized shared decision-making principles via thematic analysis of interview transcripts.

    Time frame: Baseline to 6 months post-operative

  7. Mean score Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7)

    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.

    Time frame: Baseline to 6 months post-operative

  8. Quality of life - thematic interviews

    Participant-reported perception of quality of life via thematic analysis of interview transcripts.

    Time frame: Baseline to 6 months post-operative

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2026
First posted
Nov 12, 2026
StartEst.
Nov 2026
Primary completionEst.
Nov 2027
CompletionEst.
Nov 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07933484
Lead sponsor
Yale University
Collaborators
University of Chicago Bucksbaum-Siegler Institute
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

Ajay Venkatakrishnan, MBBS
Contact
ajay.venkatakrishnan@yale.edu
(203) 640-1508
Kiran Turaga, MD
principal investigator · Yale University
Rachel Greenup, MD
principal investigator · Yale University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion