Clinical trial · Observational
A Study To See Why Patients Agree To or Decline To Have Treatment After Surgery
Why Do Patients Agree To or Decline Adjuvant Immunotherapy and Are They Satisfied With Their Decision?
NCT03843593CI-TRIAL-00063012completedClinicalTrials.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 find out what patients consider when deciding whether or not to receive adjuvant treatment, and how patients feel about their decision after one year.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Treatment Beliefs Scale10 | Behavioral | — | UNRESOLVED |
| Clinician Preference for Treatment | Behavioral | — | UNRESOLVED |
| Decisional Regret14 | Behavioral | — | UNRESOLVED |
| Demographics Questionnaire | Behavioral | — | UNRESOLVED |
| Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11 | Behavioral | — | UNRESOLVED |
| Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13 | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Melanoma patients
- description
- This is a pilot prospective study to identify the factors patients consider in deciding whether or not to undergo adjuvant therapy. Patients are eligible regardless of whether they decide to accept adjuvant therapy. If the researcher plans to treat the participant with pembrolizumab instead of nivolumab, it should be known that although the video discusses nivolumab, the risks and benefits are the same.
- interventionNames
- Behavioral: Demographics Questionnaire
- Behavioral: Adjuvant Treatment Beliefs Scale10
- Behavioral: Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11
- Behavioral: Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13
- Behavioral: Decisional Regret14
- Behavioral: Clinician Preference for Treatment
Primary outcomes (1)
- measure
- self-reported factors patients consider in deciding whether or not to undergo adjuvant therapy
- timeFrame
- 1 year
- description
- Factors considered are gleaned from the Acceptance/Declination Survey
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with stage IIIB, IIIC, IIID, or IV (AJCC, 8th edition) cutaneous melanoma rendered free of disease by surgical resection. * Patients are being offered adjuvant nivolumab or pembrolizumab therapy * Patient has not yet formally discussed their treatment options with their Medical Oncologist. * Age 18 or older. * Ability to speak and read English because we do not have the resources to translate materials into other languages. Exclusion Criteria: * Patient not currently free of disease. * Candidate for adjuvant dabrafenib/trametinib therapy. * Patients who have received prior checkpoint inhibitor therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.