Melanoma
Conditions
Keywords
Melanoma, Stage III, adjuvant, Quality of Life
Brief 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.
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
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
St. Luke's Hospital and Health Network, Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron | 1 year | To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | baseline -week 1, week 3, week 13, week 25, week 50 | 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. |
| Assess the Frequency of Grade 3 and Grade 4 Toxicities | baseline-week 1, week 3, week 13, week 25, week 50 | 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 |
| Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | baseline-week 1, week 3, week 13, week 25, week 50 | 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). |
| Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | Baseline-week 1, Week 3, week 13 week 25, week 50 | 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. |
Countries
United States
Participant flow
Recruitment details
From December 2013 to December 2017, physicians at four medical centers referred and enrolled participants to this non-randomized, observational, phase IV, multi-site pilot study. The first subject was enrolled in December 2013 and the last subject was enrolled in December 2017.
Pre-assignment details
After discussion with their treating physician, patients were to receive 1 of 2 approved adjuvant therapies for melanoma: either high-dose interferon alfa (HDI, Intron® A)\[Cohort A, arm 1\] or pegylated alfa-interferon 2b (PEG IFN, Sylatron™)\[Cohort B, arm 2\]. On this observational study, 50 subjects were included in the analysis: 26 subjects on arm 1 and 24 on arm 2.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) Induction: 20 million IU/m2 high dose interferon (HDI) as an intravenous (IV) infusion over 20 minutes, 5 consecutive days per week for 4 weeks. Maintenance: 10 million IU/m2 high dose interferon (HDI)as an subcutaneous (SC) injection 3 times per week for 48 weeks | 26 |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) Induction: 6 mcg/kg/week Pegylated Interferon (Sylatraon)subcutaneous (SC) for 8 doses. Maintenance: 3 mcg/kg/week Pegylated Interferon (Sylatraon) SC for up to 5 years (only the first year of therapy will be evaluated in this study) | 24 |
| Total | 50 |
Baseline characteristics
| Characteristic | Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Total | Arm 1/High-dose Interferon Alfa (Intron A, HDI) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 15 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 35 Participants | 18 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 24 Participants | 50 Participants | 26 Participants |
| Sex: Female, Male Female | 6 Participants | 15 Participants | 9 Participants |
| Sex: Female, Male Male | 18 Participants | 35 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 22 / 26 | 2 / 24 |
| serious Total, serious adverse events | 7 / 26 | 3 / 24 |
Outcome results
Primary
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
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron | 10 number of doses taken |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron | 38 number of doses taken |
Secondary
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
Time frame: baseline-week 1, week 3, week 13, week 25, week 50
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Assess the Frequency of Grade 3 and Grade 4 Toxicities | 74 number of grade 3 and 4 adverse events |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Assess the Frequency of Grade 3 and Grade 4 Toxicities | 5 number of grade 3 and 4 adverse events |
Secondary
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.
Time frame: baseline -week 1, week 3, week 13, week 25, week 50
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | week 50 | 12 score on a scale |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | Baseline-week 1 | 9 score on a scale |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | week 3 | 18 score on a scale |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | week 13 | 15 score on a scale |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | week 25 | 14 score on a scale |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | week 25 | 8 score on a scale |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | week 13 | 9 score on a scale |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | Baseline-week 1 | 4 score on a scale |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | week 50 | 11 score on a scale |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | week 3 | 11 score on a scale |
Secondary
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).
Time frame: baseline-week 1, week 3, week 13, week 25, week 50
Population: This outcome only applies to patients whose physician allowed them to choose their treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by convenience-not important | 9.1 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by frequency-very important | 72.9 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by frequency:somewhat important | 18.2 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by frequency: not important | 9.1 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by toxicity-very important | 54.5 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by toxicity-somewhat important | 36.4 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by toxicity-not important | 9.1 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by effectiveness-very important | 100 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by convenience-very important | 45.5 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by convenience-somewhat important | 45.5 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by length-very important | 45.5 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by length-somewhat important | 45.5 percentage of participants |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by length-not important | 9.1 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by length-somewhat important | 21.4 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by effectiveness-very important | 100 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by frequency-very important | 71.4 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by length-very important | 64.3 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by frequency:somewhat important | 28.6 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by convenience-very important | 71.4 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by frequency: not important | 0.0 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by length-not important | 14.3 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by toxicity-very important | 85.7 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by convenience-somewhat important | 28.6 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by toxicity-somewhat important | 14.3 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by convenience-not important | 0 percentage of participants |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | percentage of choice by toxicity-not important | 0 percentage of participants |
Secondary
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.
Time frame: Baseline-week 1, Week 3, week 13 week 25, week 50
Population: Fewer participants completed the questionnaire from baseline toward the week 50 time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | week 3 | 60.5 score on a scale |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | week 25 | 53 score on a scale |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | week 13 | 57 score on a scale |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | week 50 | 56 score on a scale |
| Arm 1/High-dose Interferon Alfa (Intron A, HDI) | Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | Baseline-week 1 | 28.5 score on a scale |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | week 50 | 51.5 score on a scale |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | Baseline-week 1 | 21 score on a scale |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | week 3 | 46.5 score on a scale |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | week 13 | 48 score on a scale |
| Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) | Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | week 25 | 49 score on a scale |