Expressive Disclosure and Colorectal Cancer

NCT00853203 | Unknown DMC

• 2 other identifiers: 2003-10281R21CA107306-01A2
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; Rectal Cancer; Psychosocial; Expressive Disclosure; Questionnaires; Quality of life; QOL; Electronically Activated Recorder; EAR

Outcome Measures

Primary Outcomes (1)

• To collect information about factors affecting colon and rectal cancer patients' quality of life (QOL) in order to develop a QOL program.

  3 years

Secondary Outcomes (1)

• To look at acceptability of an Expressive Disclosure Group Program for colon and rectal cancer patients, and examine its effect on quality of life.

  3 years

Study Arms (3)

Part 1

Interviews + Questionnaire + Electronically Activated Recorder (EAR)

Behavioral: Interviews; Behavioral: Questionnaires; Other: Electronically Activated Recorder (EAR)

Part 2, Expressive Disclosure Group

Group Meetings + Written Materials

Behavioral: Questionnaires; Behavioral: Group Meetings; Behavioral: Written Materials

Part 2, Standard Care Control Group

Written Materials

Behavioral: Questionnaires; Behavioral: Written Materials

Interventions

Interviews BEHAVIORAL

Open-ended Interviews, audiotaped, lasting 30 minutes to 1 hour.

Also known as: Questionnaires

Part 1

Questionnaires BEHAVIORAL

Written survey taking about 1 hour.

Part 1; Part 2, Expressive Disclosure Group; Part 2, Standard Care Control Group

Electronically Activated Recorder (EAR) OTHER

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 1

Group Meetings BEHAVIORAL

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.

Part 2, Expressive Disclosure Group

Written Materials BEHAVIORAL

Written educational materials plus community resource information.

Part 2, Expressive Disclosure Group; Part 2, Standard Care Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population of 174 participants diagnosed with colorectal cancer.

You may qualify if:

• 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.

You may not qualify if:

• Part 1 - Descriptive Study:
• \. Not being able to provide informed consent.
• Part 2 - Pilot Randomized Trial:
• \. Not being able to provide informed consent.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Kelsey-Seybold Clinics

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Interviews as Topic; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cindy L. Carmack Taylor, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Karen Basen-Engquist, PHD, BA, MPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Study Start: January 1, 2009
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

US (2)