- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01356251
Psychosocial Needs and Exploration of Online Support for Patients With Mesothelioma
February 7, 2023 updated by: Memorial Sloan Kettering Cancer Center
Mesothelioma From a Patient Perspective: A Survey of Psychosocial Needs and Exploration of Online Support for Patients
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
107
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
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.
|
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To describe the psychological needs of patients with mesothelioma.
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the aim is to explore the acceptability and promise of an Internet-based discussion group for patients with mesothelioma.
Time Frame: 1 year
|
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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2011
Primary Completion (ACTUAL)
February 6, 2023
Study Completion (ACTUAL)
February 6, 2023
Study Registration Dates
First Submitted
May 17, 2011
First Submitted That Met QC Criteria
May 18, 2011
First Posted (ESTIMATE)
May 19, 2011
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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