Cutaneous Melanoma
Conditions
Keywords
Decline Adjuvant Immunotherapy, Agree To Adjuvant Immunotherapy, Nivolumab, Pembrolizumab, 19-012
Brief 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.
Interventions
BEHAVIORALDemographics Questionnaire
A brief questionnaire will collect basic demographic information (i.e., age, gender, racial background, ethnicity, employment status, marital status) at time of enrollment.
BEHAVIORALAdjuvant 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.
BEHAVIORALFunctional 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.
BEHAVIORALFunctional 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.
BEHAVIORALDecisional 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 \[Strongly Disagree\].
BEHAVIORALClinician 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| self-reported factors patients consider in deciding whether or not to undergo adjuvant therapy | 1 year | Factors considered are gleaned from the Acceptance/Declination Survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| self-reported quality of life | 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). |
Countries
United States
Outcome results
None listed