MelanomaNCT01986712
A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon in Patients With Surgically Resected Melanoma
An observational study of Melanoma, run by St. Luke's Hospital and Health Network, Pennsylvania at 4 sites in United States.
Trial summary
To evaluate the compliance with and perceptions of treatment, as well as health-related quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG IFN therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2013to 17 Sep 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients with surgically resected melanoma receiving adjuvant therapy with HDI or PEG IFN thherapy
Who may be able to join
- Patient is male or female at least 18 years of age
- Patient has had surgically resected melanoma and plans to receive adjuvant therapy with HDI or PEG IFN
- Patient is willing and able to give written informed consent
- Patient is willing to comply with all study requirements
Who cannot join
- Patient is unable or unwilling to complete QoL questionaire or compliance diary
- Patient has a history of anaphylaxis due to any interferon alpha product
- Patient has autoimmune hepatitis
- Patient has decompensated liver disease (Child-Pugh score>6 ( Class B and C)
- Patient has a history of neuropsychiatric disorder (including depression) that, in the judgment of the investigator, may impair the patient's ability to successfully complete treatment or protocol-related requirements
Trial locations and contacts
4 sites in 1 country.
United States4 sites
St Luke's University Hospital and Health Network
Bethlehem, Pennsylvania, 18015
Roswell Park Cancer Institute
Buffalo, New York, 14263
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
Moffit Cancer Center
Tampa, Florida, 33612
About this study
Official title: An Observational Pilot Study to Compare the Compliance With and Health Related Quality of Life During Therapy With Standard High-Dose Interferon Alfa (Intron A, HDI) Versus Pegylated Alfa-Interferon 2b (Sylatron, PEG IFN) in Patients With Surgically Resected Melanoma
To evaluate the compliance with and perceptions of treatment, as well as health-related quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG IFN therapy.
Read the detailed description
The primary objective of this study is:
- To evaluate compliance with the administration of standard HDI versus PEG IFN for patients with melanoma in need of adjuvant therapy
The secondary objectives of this study are:
- To compare the convenience and satisfaction with chemotherapy for patients on standard HDI versus PEG IFN using a chemotherapy convenience and satisfaction questionnaire (CCSQ) and to evaluate the treatment-related side effects that may impact the patient's HRQOL using the Functional Assessment of Cancer Therapy of Biologic Response Modifier (FACT BRM)
- To assess the frequency of Grade 3 and 4 toxicities, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) for patients on standard HDI versus PEG IFN
- To examine reasons for patients' choice of treatment with HDI versus PEG IFN, for those cases in which patients are presented with a choice of either treatment option
- To assess Health Resource Utilization on both arms of the study
- Conditions
- Melanoma
- Keywords
- Melanoma, Stage III, adjuvant, Quality of Life
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intron A, HDI | High-dose interferon alfa (Intron A, HDI) | |
| Sylatron | Pegylated alfa-interferon 2b (Sylatron, PEG IFN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron
To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy
Measured: 1 year
Secondary outcomes (4)
Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN
To compare QOL for patients on standard HDI versus PEG IFN using chemotherapy convenience and satisfaction questionnaire (CCSQ).
The CCSQ measures the construct "chemotherapy convenience and satisfaction" and includes 10 questions [scores from 0 ("not at all") to 4 ("very much"), maximum possible summative score = 40]. Higher scores signify a better outcome. Minimum possible summative score = 0.
Measured: baseline -week 1, week 3, week 13, week 25, week 50
Assess the Frequency of Grade 3 and Grade 4 Toxicities
To assess the frequency of Grade 3 and 4 toxicities, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) for patients on standard HDI versus PEG IFN
Measured: baseline-week 1, week 3, week 13, week 25, week 50
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN
To examine reasons for patients' choice of treatment HDI versus PEG IFN, for those cases in which patients are presented with a choice of either treatment option (percentage answering "very important", "somewhat important", or "not important" for "frequency", "toxicity", "effectiveness", "convenience", and "length").
Measured: baseline-week 1, week 3, week 13, week 25, week 50
Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM)
To compare QOL for patients on standard HDI versus PEG IFN using the Functional Assessment of Cancer Therapy - biologic response modifier, questionnaire (FACT-BRM).
The FACT-BRM measures the construct "Functional Assessment of Cancer Therapy" and includes 40 questions [scores from 0 ("not at all") to 4 ("very much"), maximum possible summative score = 160]. Due to the nature of their items, the Social/Family Well-Being and Functional Well-Being subscale scores were reverse coded. For the summative score, higher scores signify a worse outcome. Minimum possible summative score = 0.
Measured: Baseline-week 1, Week 3, week 13 week 25, week 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startDec 2013
- Primary completion18 Jul 2018
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital and Health Network, Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Neil Belman, St. Luke's Hospital and Health Network, Pennsylvania
- Investigators
- Neil Belman, DO, Principal investigator, St. Luke's Hospital and Health Network, Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986712
- Sponsor's protocol ID
- Merck MISP 50422
- Status last verified
- Jan 2025
- First submitted
- 23 Oct 2013
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Pilot Study to Compare the Compliance With and Health Related Quality of Life During Therapy With Standard High-Dose Interferon Alfa (Intron A, HDI) Versus Pegylated Alfa-Interferon 2b (Sylatron, PEG IFN) in Patients With Surgically Resected Melanoma
- ClinicalTrials.gov ID
- NCT01986712
- Acronym / sponsor ID
- Merck MISP 50422
- Conditions
- Melanoma
- Keywords
- Melanoma, Stage III, adjuvant, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Luke's Hospital and Health Network, PennsylvaniaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2013
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Posted 13 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the compliance with and perceptions of treatment, as well as health-related quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG IFN therapy.
Detailed description
The primary objective of this study is:
- To evaluate compliance with the administration of standard HDI versus PEG IFN for patients with melanoma in need of adjuvant therapy
The secondary objectives of this study are:
- To compare the convenience and satisfaction with chemotherapy for patients on standard HDI versus PEG IFN using a chemotherapy convenience and satisfaction questionnaire (CCSQ) and to evaluate the treatment-related side effects that may impact the patient's HRQOL using the Functional Assessment of Cancer Therapy of Biologic Response Modifier (FACT BRM)
- To assess the frequency of Grade 3 and 4 toxicities, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) for patients on standard HDI versus PEG IFN
- To examine reasons for patients' choice of treatment with HDI versus PEG IFN, for those cases in which patients are presented with a choice of either treatment option
- To assess Health Resource Utilization on both arms of the study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intron A, HDI | – | –High-dose interferon alfa (Intron A, HDI) |
| Sylatron | – | –Pegylated alfa-interferon 2b (Sylatron, PEG IFN) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with surgically resected melanoma receiving adjuvant therapy with HDI or PEG IFN thherapy
Key inclusion criteria (4 listed)
- Patient is male or female at least 18 years of age
- Patient has had surgically resected melanoma and plans to receive adjuvant therapy with HDI or PEG IFN
- Patient is willing and able to give written informed consent
- Patient is willing to comply with all study requirements
Key exclusion criteria (5 listed)
- Patient is unable or unwilling to complete QoL questionaire or compliance diary
- Patient has a history of anaphylaxis due to any interferon alpha product
- Patient has autoimmune hepatitis
- Patient has decompensated liver disease (Child-Pugh score>6 ( Class B and C)
- Patient has a history of neuropsychiatric disorder (including depression) that, in the judgment of the investigator, may impair the patient's ability to successfully complete treatment or protocol-related requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron
Time frame: 1 year
To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy
4 secondary outcomes
Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN
Time frame: baseline -week 1, week 3, week 13, week 25, week 50
Assess the Frequency of Grade 3 and Grade 4 Toxicities
Time frame: baseline-week 1, week 3, week 13, week 25, week 50
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN
Time frame: baseline-week 1, week 3, week 13, week 25, week 50
Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM)
Time frame: Baseline-week 1, Week 3, week 13 week 25, week 50
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Neil Belman, DO principal investigator
St. Luke's Hospital and Health Network, Pennsylvania
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by St. Luke's Hospital and Health Network, Pennsylvania at 4 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 4 inclusion and 5 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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron (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 13 Feb 2025.