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

Cutaneous Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843593
• Other study ID #: 19-012
• Status: Completed
• Start date: February 14, 2019
• Est. completion date: December 29, 2022

Study information

• Verified date: January 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 29, 2022
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Melanoma
• Melanoma

Intervention

Behavioral:
• Demographics Questionnaire
A brief questionnaire will collect basic demographic information (i.e., age, gender, racial background, ethnicity, employment status, marital status) at time of enrollment.
• Adjuvant Treatment Beliefs Scale10
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.
• 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.
• Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13
FACIT-TS-G is a brief, 8-item self-administered measure designed to assess general treatment satisfaction in patients.
• Decisional Regret14
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].
• Clinician Preference for Treatment
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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Memorial Sloan Kettering Cancer Center