Psychosocial Needs and Exploration of Online Support for Patients With Mesothelioma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01356251
First received: May 17, 2011
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

The aim of this study is to learn about how mesothelioma affects patients' emotional and physical well-being. Also, the investigators would like to learn more about what patients need and how they deal with this illness. This information can help us find ways to lessen physical and emotional strains. Part of the study tests an alternate way of giving emotional support through the Internet. By providing support online, patients can participate in the comfort of their home.


Condition Intervention
Mesothelioma
Behavioral: Questionnaires & online virtual support group

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mesothelioma From a Patient Perspective: A Survey of Psychosocial Needs and Exploration of Online Support for Patients

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To describe the psychological needs of patients with mesothelioma. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patients'psychological symptom burden will be assessed by the set of questionnaires administered in part 1 of the study. scores of the assessments of coping (28-item Brief Cope), social support (6-item SSQ-SF), depressive symptoms (20-item Zung), and quality of life (36-item FACT-Lung).


Secondary Outcome Measures:
  • the aim is to explore the acceptability and promise of an Internet-based discussion group for patients with mesothelioma. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The investigators will summarize acceptability and gather pilot data on the promise of the intervention. Acceptability in this study will be assessed through the enrollment rate (percentage of eligible individuals consented and recruited into the Internet-based discussion group). The adherence rate will be the percentage of enrolled patients who complete all virtual group sessions.


Estimated Enrollment: 90
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgical group with mesothelioma
The study proposed here has two parts: part 1 surveys mesothelioma patients' psychological and physical symptom burden and quality of life through a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. In part 2, patients are invited to participate in an Internet-based discussion group.
Behavioral: Questionnaires & online virtual support group
Part 1 surveys mesothelioma patients' psychological and physical symptom burden and quality of life by administering a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. All mesothelioma patients who complete the questionnaires in part 1 will be offered an opportunity to participate in a trial of a therapeutic Internet-based discussion group. The groups will consist of either approximately 3-5 surgical patients or approximately 3-5 non-surgical patients. The groups will run for approximately 60 minutes once a week for six consecutive weeks.
Experimental: Non Surgical group with mesothelioma
The study proposed here has two parts: part 1 surveys mesothelioma patients' psychological and physical symptom burden and quality of life through a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. In part 2, patients are invited to participate in an Internet-based discussion group
Behavioral: Questionnaires & online virtual support group
Part 1 surveys mesothelioma patients' psychological and physical symptom burden and quality of life by administering a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. All mesothelioma patients who complete the questionnaires in part 1 will be offered an opportunity to participate in a trial of a therapeutic Internet-based discussion group. The groups will consist of either 3-5 surgical patients or 3-5 non-surgical patients. The groups will run for approximately 60 minutes once a week for six consecutive weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of pleural mesothelioma and receiving care at MSKCC
  • At least 18 years of age or older
  • Able to read and speak English
  • Patients who choose to participate in the Internet-based discussion groups, need a telephone, a computer, Internet access, and an e-mail account.

Exclusion Criteria:

  • Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in a group-format intervention (i.e., acute psychiatric symptoms which require individual treatment).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356251

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Richard G. Key, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01356251     History of Changes
Other Study ID Numbers: 11-066
Study First Received: May 17, 2011
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Quality of life
support group
questionnaires
Internet-based support group
11-066

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on July 20, 2014