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

Completed

• Conditions: Cutaneous Melanoma
• Interventions: 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

• Registration Number: NCT03843593
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-02-14
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-18
• Primary Completion: 2022-12-29
• Study Completion: 2022-12-29
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

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Exclusion Criteria

• Patient not currently free of disease.
• Candidate for adjuvant dabrafenib/trametinib therapy.
• Patients who have received prior checkpoint inhibitor therapy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Melanoma patients	Demographics Questionnaire	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.
Melanoma patients	Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11	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.
Melanoma patients	Decisional Regret14	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.
Melanoma patients	Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13	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.
Melanoma patients	Adjuvant Treatment Beliefs Scale10	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.
Melanoma patients	Clinician Preference for Treatment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
self-reported quality of life	1 year	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).

Trial Locations

Locations (3)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States