Expressive Disclosure and Colorectal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00853203
First received: February 27, 2009
Last updated: October 22, 2012
Last verified: October 2012
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Purpose
This is a Two-part Pilot Study: Part 1 is descriptive and Part 2 is a pilot randomized trial.
Part 1 will be a formative study in which individual interviews are conducted with 20 patients previously diagnosed with colorectal cancer. During open-ended interviews, researchers will collect data on QOL issues colorectal cancer patients face and will elicit feedback regarding development of and participation in a pilot expressive disclosure intervention. Patients also will pilot test an assessment procedures including completing the written questionnaires and wearing the Electronically Activated Recorder (EAR).
Part 2 will include a small randomized pilot test in which 44 patients (two cohorts of 22 patients) will be randomly assigned to the Expressive Disclosure Group Program or a Standard Care Control Group.
Aims of the study include:
- To conduct a descriptive study of colorectal cancer patients, through qualitative interviews and standardized questionnaires, in an effort to assess their QOL, specific health and emotional problems, issues related to social functioning, and preferences regarding intervention format and logistics.
- To use the information from the descriptive study to develop an Expressive Disclosure Group Program for colorectal cancer patients.
- To pilot test a novel technology called the Electronically Activated Recorder (EAR) for assessing cognitive processing and social support in colorectal cancer patients and compare these data to those obtained with traditional self-report measures.
- To pilot test the Expressive Disclosure Group Program and conduct process evaluation including rates of recruitment and retention, attendance, satisfaction, barriers to participation, and feasibility of randomization.
- To explore the effects of the Expressive Disclosure Group Program on outcome variables of QOL and psychological functioning and mediating variables of cognitive processing, coping skills, and social support.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Behavioral: Interviews Behavioral: Questionnaires Other: Electronically Activated Recorder (EAR) Behavioral: Group Meetings Behavioral: Written Materials |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Expressive Disclosure Program for Colorectal Cancer Patients |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- To collect information about factors affecting colon and rectal cancer patients' quality of life (QOL) in order to develop a QOL program. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To look at acceptability of an Expressive Disclosure Group Program for colon and rectal cancer patients, and examine its effect on quality of life. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 174 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Part 1
Interviews + Questionnaire + Electronically Activated Recorder (EAR)
|
Behavioral: Interviews
Open-ended Interviews, audiotaped, lasting 30 minutes to 1 hour.
Other Name: Questionnaires
Behavioral: Questionnaires
Written survey taking about 1 hour.
Other: Electronically Activated Recorder (EAR)
Recording system (a digital tape-recorder and small external microphone) programmed to record for 30 seconds every 12 minutes, repeating over two consecutive days of wearing.
|
|
Part 2, Expressive Disclosure Group
Group Meetings + Written Materials
|
Behavioral: Questionnaires
Written survey taking about 1 hour.
Behavioral: Group Meetings
12 Audiotaped Group Meetings over 4 months: 9 weekly meetings, 2 semi-monthly (twice a month) meetings, and a final meeting in month 4. Each meeting will last 1 hour.
Behavioral: Written Materials
Written educational materials plus community resource information.
|
|
Part 2, Standard Care Control Group
Written Materials
|
Behavioral: Questionnaires
Written survey taking about 1 hour.
Behavioral: Written Materials
Written educational materials plus community resource information.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Study population of 174 participants diagnosed with colorectal cancer.
Criteria
Inclusion Criteria:
Part 1 - Descriptive Study:
- having a diagnosis of stage I, II, or III colon or rectal cancer;
- having completed treatment for colon or rectal cancer within the past year;
- having the ability to read, speak and write English;
- being a resident of the State of Texas; and
- being 18 years old or older.
Part 2 - Pilot Randomized Trial:
- having a diagnosis of stage I, II, or III colon or rectal cancer;
- having completed treatment for colon or rectal cancer;
- being a distressed patient: a T score >63 on the Global Severity Index (GSI) of the Brief Symptom Inventory (BSI) or a T score >63 on any two primary dimensions of this measure;
- having the ability to read, speak and write English;
- residing within one hour of M.D. Anderson Cancer Center; and
- being 18 years old or older.
Exclusion Criteria:
Part 1 - Descriptive Study:
1. Not being able to provide informed consent.
Part 2 - Pilot Randomized Trial:
1. Not being able to provide informed consent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853203
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Kelsey-Seybold Clinics | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Cindy C Taylor, PHD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00853203 History of Changes |
| Other Study ID Numbers: | 2003-1028 |
| Study First Received: | February 27, 2009 |
| Last Updated: | October 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Colorectal Cancer Rectal Cancer Psychosocial Expressive Disclosure Questionnaires |
Quality of life QOL Electronically Activated Recorder EAR |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013