Expressive Disclosure and Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00853203
First received: February 27, 2009
Last updated: October 23, 2013
Last verified: October 2013
  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 2015 (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:

  1. having a diagnosis of stage I, II, or III colon or rectal cancer;
  2. having completed treatment for colon or rectal cancer within the past year;
  3. having the ability to read, speak and write English;
  4. being a resident of the State of Texas; and
  5. being 18 years old or older.

Part 2 - Pilot Randomized Trial:

  1. having a diagnosis of stage I, II, or III colon or rectal cancer;
  2. having completed treatment for colon or rectal cancer;
  3. 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;
  4. having the ability to read, speak and write English;
  5. residing within one hour of M.D. Anderson Cancer Center; and
  6. 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
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: 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 23, 2013
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 August 01, 2014