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?
1 other identifier
observational
38
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2019
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2019
CompletedStudy Start
First participant enrolled
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2022
CompletedJanuary 4, 2023
January 1, 2023
3.9 years
February 14, 2019
January 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
self-reported quality of life
1 year
Study Arms (1)
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.
Interventions
A brief questionnaire will collect basic demographic information (i.e., age, gender, racial background, ethnicity, employment status, marital status) at time of enrollment.
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.
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.
FACIT-TS-G is a brief, 8-item self-administered measure designed to assess general treatment satisfaction in patients.
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 \[Strongly Disagree\].
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
Potential research participants will be identified by members of the Melanoma service, the patients" treatment team, or the PI.
You may qualify if:
- 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.
You may not qualify if:
- Patient not currently free of disease.
- Candidate for adjuvant dabrafenib/trametinib therapy.
- Patients who have received prior checkpoint inhibitor therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Chapman, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2019
First Posted
February 18, 2019
Study Start
February 14, 2019
Primary Completion
December 29, 2022
Study Completion
December 29, 2022
Last Updated
January 4, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF
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: [email protected].