A Study To See Why Patients Agree To or Decline To Have Treatment After Surgery
NCT ID: NCT03843593
Last Updated: 2023-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
38 participants
OBSERVATIONAL
2019-02-14
2022-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Candidate for adjuvant dabrafenib/trametinib therapy.
* Patients who have received prior checkpoint inhibitor therapy.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Paul Chapman, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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19-012
Identifier Type: -
Identifier Source: org_study_id
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