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Completed

NCT Number: NCT03843593

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

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.

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Key information

Conditions

Cutaneous Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Demographics Questionnaire

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

FACIT-TS-G is a brief, 8-item self-administered measure designed to assess general treatment satisfaction in patients.

Decisional Regret14

Behavioral

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

Behavioral

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.

Primary outcomes

  1. self-reported factors patients consider in deciding whether or not to undergo adjuvant therapy

    Time frame: 1 year

    Factors considered are gleaned from the Acceptance/Declination Survey

Secondary outcomes

  1. self-reported quality of life

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2019
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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