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?

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.

Study Overview

• Status: Completed
• Conditions: Cutaneous Melanoma
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  • New York
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (All Protocol Activities)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential research participants will be identified by members of the Melanoma service, the patients" treatment team, or the PI.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Melanoma patients; 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; A brief questionnaire will collect basic demographic information (i.e., age, gender, racial background, ethnicity, employment status, marital status) at time of enrollment.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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].; Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Actual): December 29, 2022
• Study Completion (Actual): December 29, 2022

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Nivolumab; Pembrolizumab; Decline Adjuvant Immunotherapy; Agree To Adjuvant Immunotherapy; 19-012
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 19-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No