NCT03843593

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?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cutaneous Melanoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-14
• Primary completion: 2022-12-29
• Completion: 2022-12-29
• First posted: 2019-02-18
• Last updated: 2023-01-04

Locations

3 sites across 1 country: United States