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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01356251
Other study ID # 11-066
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2011
Est. completion date February 6, 2023

Study information

Verified date February 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date February 6, 2023
Est. primary completion date February 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To describe the psychological needs of patients with mesothelioma. 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). 1 year
Secondary the aim is to explore the acceptability and promise of an Internet-based discussion group for patients with mesothelioma. 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. 1 year
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