A Study To See Why Patients Agree To or Decline To Have Treatment After Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Why Do Patients Agree To or Decline Adjuvant Immunotherapy and Are They Satisfied With Their Decision?

Conditions
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Cutaneous Melanoma

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Melanoma patients<br>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. | Behavioral: Demographics Questionnaire<br>* A brief questionnaire will collect basic demographic information (i.e., age, gender, racial background, ethnicity, employment status, marital status) at time of enrollment.<br>Behavioral: Adjuvant Treatment Beliefs Scale10<br>* This brief PRO measure asks patients to indicate the likelihood, using a 5-point Likert type scale (1 [definitely not], 2 [probably not], 3 [maybe], 4 [probably], 5 [definitely]) of six positive (e.g., reduced risk of recurrence, greater chance of being cured) and five negative outcomes (e.g., side effects, health status) of adjuvant treatment.<br>Behavioral: Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11<br>* FACT-M is a 51-item patient-self report measure for the assessment of quality of life (QOL) in patients with American Joint Committee on Cancer stages I through IV melanoma.<br>Behavioral: Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13<br>* FACIT-TS-G is a brief, 8-item self-administered measure designed to assess general treatment satisfaction in patients.<br>Behavioral: Decisional Regret14<br>* This is a set of 5 questions examining level of regret for treatment decisions (in this case, decision to pursue adjuvant therapy), with answers scored on a 5-point Likert-type scale (i.e., 1 [Strongly Agree], 2 [Agree], 3 [Neither Agree Nor Disagree], 4 [Disagree], 5 [Strongly Disagree].<br>Behavioral: Clinician Preference for Treatment<br>* This is a single item to be completed by Medical Oncologists that will indicate their preference as to whether they prefer that their patient accepts adjuvant therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-reported factors patients consider in deciding whether or not to undergo adjuvant therapy | Factors considered are gleaned from the Acceptance/Declination Survey | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-reported quality of life | as captured by FACT-M, as well as treatment satisfaction. Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11 - FACT-M is a 51- item patient-self report measure for the assessment of quality of life (QOL) in patients with American Joint Committee on Cancer stages I through IV melanoma.The FACT-M incorporates a recall period of 7-days and a five-point Likert-type scale (i.e., 0 = Not at all, 1 = A little bit, 2 = Somewhat, 3 = Quite a bit, 4 = Very much). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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19-012, Decline Adjuvant Immunotherapy, Agree To Adjuvant Immunotherapy, Nivolumab, Pembrolizumab