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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Cutaneous Melanoma

Treatments: Behavioral: Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13; Behavioral: Clinician Preference for Treatment; Behavioral: Demographics Questionnaire; Behavioral: Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11; Behavioral: Decisional Regret14; Behavioral: Adjuvant Treatment Beliefs Scale10

Study type: Observational

Funder types: Other

Identifiers

NCT03843593

19-012

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

38 participants in 1 patient group

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.

Treatment:

Behavioral: Clinician Preference for Treatment

Behavioral: Decisional Regret14

Behavioral: Demographics Questionnaire

Behavioral: Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13

Behavioral: Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11

Behavioral: Adjuvant Treatment Beliefs Scale10