A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon in Patients With Surgically Resected Melanoma

Completed

Conditions: Melanoma

Registration Number: NCT01986712

Lead Sponsor: St. Luke's Hospital and Health Network, Pennsylvania

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4): Moffit Cancer Center
🇺🇸
Tampa, Florida, United States
St Luke's University Hospital and Health Network
🇺🇸
Bethlehem, Pennsylvania, United States
Huntsman Cancer Institute
🇺🇸
Salt Lake City, Utah, United States
Roswell Park Cancer Institute
🇺🇸
Buffalo, New York, United States