NCT01356251

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

11.8 years

First QC Date

May 17, 2011

Last Update Submit

February 7, 2023

Conditions

Mesothelioma

Keywords

Quality of lifesupport groupquestionnairesInternet-based support group11-066

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • the aim is to explore the acceptability and promise of an Internet-based discussion group for patients with mesothelioma.

    1 year

Study Arms (2)

Surgical group with mesothelioma

EXPERIMENTAL

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

Non Surgical group with mesothelioma

EXPERIMENTAL

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

Interventions

Questionnaires & online virtual support groupBEHAVIORAL

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.

Surgical group with mesothelioma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Mesothelioma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Christian Nelson, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 19, 2011

Study Start

May 1, 2011

Primary Completion

February 6, 2023

Study Completion

February 6, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

US(1)