Cutaneous MelanomaNCT03843593
A Study To See Why Patients Agree To or Decline To Have Treatment After Surgery
An observational study of Cutaneous Melanoma, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma
- What is being tested?
- Demographics Questionnaire, Adjuvant Treatment Beliefs Scale10 and Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Feb 2019to 29 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential research participants will be identified by members of the Melanoma service, the patients" treatment team, or the PI.
Who may be able to join
- 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.
Who cannot join
- Patient not currently free of disease.
- Candidate for adjuvant dabrafenib/trametinib therapy.
- Patients who have received prior checkpoint inhibitor therapy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Why Do Patients Agree To or Decline Adjuvant Immunotherapy and Are They Satisfied With Their Decision?
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
- Being tested
- Demographics Questionnaire, Adjuvant Treatment Beliefs Scale10, Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11, Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13, Decisional Regret14
- Keywords
- Decline Adjuvant Immunotherapy, Agree To Adjuvant Immunotherapy, Nivolumab, Pembrolizumab, 19-012
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demographics QuestionnaireBehavioural
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 Scale10Behavioural
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)11Behavioural
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)13Behavioural
FACIT-TS-G is a brief, 8-item self-administered measure designed to assess general treatment satisfaction in patients.
Decisional Regret14Behavioural
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 TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Demographics Questionnaire; Behavioral: Adjuvant Treatment Beliefs Scale10; Behavioral: Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11; Behavioral: Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13; Behavioral: Decisional Regret14; Behavioral: Clinician Preference for Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported factors patients consider in deciding whether or not to undergo adjuvant therapy
Factors considered are gleaned from the Acceptance/Declination Survey
Measured: 1 year
Secondary outcomes (1)
self-reported quality of life
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start14 Feb 2019
- Primary completion29 Dec 2022
- Study completion29 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Chapman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843593
- Sponsor's protocol ID
- 19-012
- Status last verified
- Jan 2023
- First submitted
- 14 Feb 2019
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why Do Patients Agree To or Decline Adjuvant Immunotherapy and Are They Satisfied With Their Decision?
- ClinicalTrials.gov ID
- NCT03843593
- Acronym / sponsor ID
- 19-012
- Conditions
- Cutaneous Melanoma
- Keywords
- Decline Adjuvant Immunotherapy, Agree To Adjuvant Immunotherapy, Nivolumab, Pembrolizumab, 19-012
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanoma patients | – | Behavioral: Demographics Questionnaire, Behavioral: Adjuvant Treatment Beliefs Scale10, Behavioral: Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11, Behavioral: Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13, Behavioral: Decisional Regret14, Behavioral: Clinician Preference for TreatmentThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research participants will be identified by members of the Melanoma service, the patients" treatment team, or the PI.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient not currently free of disease.
- Candidate for adjuvant dabrafenib/trametinib therapy.
- Patients who have received prior checkpoint inhibitor therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demographics QuestionnaireA brief questionnaire will collect basic demographic information (i.e., age, gender, racial background, ethnicity, employment status, marital status) at time of enrollment. | Behavioural | Melanoma patients |
| Adjuvant Treatment Beliefs Scale10This 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. | Behavioural | Melanoma patients |
| Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11FACT-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. | Behavioural | Melanoma patients |
| Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13FACIT-TS-G is a brief, 8-item self-administered measure designed to assess general treatment satisfaction in patients. | Behavioural | Melanoma patients |
| Decisional Regret14This 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]. | Behavioural | Melanoma patients |
| Clinician Preference for TreatmentThis 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. | Behavioural | Melanoma patients |
Primary outcome
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
1 secondary outcome
self-reported quality of life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Chapman, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Melanoma, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported factors patients consider in deciding whether or not to undergo adjuvant therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.