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NCT Number: NCT01986712

A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon 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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffit Cancer Center, Tampa, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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.

  2. Assess the Frequency of Grade 3 and Grade 4 Toxicities

    Time frame: 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

  3. 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

    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").

  4. 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

    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.

Sponsors and collaborators

Lead sponsor

St. Luke's Hospital and Health Network, Pennsylvania

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Nov 18, 2013
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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