Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00853203
Status:
UNKNOWN
Last Update Posted:
2020-12-21
First Post:
2009-02-27
Brief Title:
Expressive Disclosure and Colorectal Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Expressive Disclosure Program for Colorectal Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Colon and rectal cancer patients will be asked to participate in this study
Part 1
Participation in this study will include three tasks
First you will participate in individual interviews during which questions about quality of life will be asked You also will be provided information about a new expressive disclosure group program for colon and rectal cancer patients after which you will be asked your opinions about the program The entire individual interview will last 30 minutes to 1 hour The interviews will be audiotaped and then the study staff will make a written copy of the answers given on the tapes to be used in analysis
Second you will be asked to complete questionnaires about your medical history quality of life mood thought processes coping style and social support It will take about 1 hour to complete the questionnaires
Third you will be asked to wear an Electronically Activated Recorder EAR for two days in a row The EAR is a recording system consisting of a digital tape-recorder and a small external microphone The EAR is programmed to record for 30 seconds at a time and then is off for 12 minutes It repeats this 125 minute cycle the entire time while worn for two days The recordings from the EAR will provide information about your daily activities The study staff will make a written copy of what is said on the recordings for analysis Before returning the EAR device you will be given the opportunity to schedule an appointment where you can listen to the recordings and erase any portion that you think is embarrassing or private If participants have no concerns about the EAR recordings the EAR can be returned in a prepaid mailing packet After wearing the EAR you will complete an evaluation questionnaire over the phone which will take about 5 minutes
This is an investigational study A total of 25 colon and rectal cancer patients will be asked to participate in this study Participants will be from MD Anderson Cancer Center and Kelsey-Seybold Clinics
Part 2
You will first be asked to complete a brief questionnaire about your mood If the answers to the questionnaire indicate that you are distressed you will be eligible for the remainder of the study Only those participants who score as distressed will stay in the study Regardless of your answers you will be informed of your test results and provided with a list of community referrals If your responses to the questionnaire indicate potential harm to yourself a licensed psychologist will follow-up with you and make recommendations which may include mental health referrals at MD Anderson andor in the community
If the first questionnaire indicates that you are distressed you will be asked to complete additional questionnaires about your medical history quality of life mood thought processes coping style and social support It will take about 1 hour to complete the questionnaires
You also will be asked to wear an Electronically Activated Recorder EAR for two days in a row The EAR is a recording system consisting of a digital tape-recorder and a small external microphone The EAR is programmed to record for 30 seconds at a time and then is off for 12 minutes It repeats this 125 minute cycle the entire time while worn for two days The recordings from the EAR will provide information about your daily activities The study staff will make a written copy of what is said on the recordings for analysis Before returning the EAR device you will be given the opportunity to schedule an appointment where you can listen to the recordings and erase any portion that you think is embarrassing or private If participants have no concerns about the EAR recordings the EAR can be returned in a prepaid mailing packet After wearing the EAR you will complete an evaluation questionnaire over the phone which will take about 5 minutes
You will complete the questionnaires when you enter the study 2 months after entering the study and 4 months after entering the study You also will be asked to wear the EAR for 2 days when you enter the study and for 2 days at 4 months after entering the study
You will be assigned randomly as in the toss of a coin to one of two programs the Expressive Disclosure Group Program or the Standard Care Program
Patients in the Expressive Disclosure Group Program will attend groups with about 11 members The program will include 12 group meetings over the course of 4months 9 weekly meetings 2 semi-monthly twice a month meetings and a final meeting in month 4 Each meeting will last 1 hour This program will involve talking and writing about several topics that are important for individuals facing colon and rectal cancer Participants in this program also will receive written educational material and information about community resources Group meetings will be audio-taped Copies of tapes will be provided to participants when they miss a session Tapes will sometimes be reviewed by project investigators to make sure the groups are covering the program content
Patients in the Standard Care Program will not attend any formal group meetings They will receive by mail written educational material and information about community resources
This is an investigational study A total of 149 individuals diagnosed with colon or rectal cancer will take part in this study 131 from M D Anderson and 18 from Kelsey-Seybold Clinics
Part 1
Participation in this study will include three tasks
First you will participate in individual interviews during which questions about quality of life will be asked You also will be provided information about a new expressive disclosure group program for colon and rectal cancer patients after which you will be asked your opinions about the program The entire individual interview will last 30 minutes to 1 hour The interviews will be audiotaped and then the study staff will make a written copy of the answers given on the tapes to be used in analysis
Second you will be asked to complete questionnaires about your medical history quality of life mood thought processes coping style and social support It will take about 1 hour to complete the questionnaires
Third you will be asked to wear an Electronically Activated Recorder EAR for two days in a row The EAR is a recording system consisting of a digital tape-recorder and a small external microphone The EAR is programmed to record for 30 seconds at a time and then is off for 12 minutes It repeats this 125 minute cycle the entire time while worn for two days The recordings from the EAR will provide information about your daily activities The study staff will make a written copy of what is said on the recordings for analysis Before returning the EAR device you will be given the opportunity to schedule an appointment where you can listen to the recordings and erase any portion that you think is embarrassing or private If participants have no concerns about the EAR recordings the EAR can be returned in a prepaid mailing packet After wearing the EAR you will complete an evaluation questionnaire over the phone which will take about 5 minutes
This is an investigational study A total of 25 colon and rectal cancer patients will be asked to participate in this study Participants will be from MD Anderson Cancer Center and Kelsey-Seybold Clinics
Part 2
You will first be asked to complete a brief questionnaire about your mood If the answers to the questionnaire indicate that you are distressed you will be eligible for the remainder of the study Only those participants who score as distressed will stay in the study Regardless of your answers you will be informed of your test results and provided with a list of community referrals If your responses to the questionnaire indicate potential harm to yourself a licensed psychologist will follow-up with you and make recommendations which may include mental health referrals at MD Anderson andor in the community
If the first questionnaire indicates that you are distressed you will be asked to complete additional questionnaires about your medical history quality of life mood thought processes coping style and social support It will take about 1 hour to complete the questionnaires
You also will be asked to wear an Electronically Activated Recorder EAR for two days in a row The EAR is a recording system consisting of a digital tape-recorder and a small external microphone The EAR is programmed to record for 30 seconds at a time and then is off for 12 minutes It repeats this 125 minute cycle the entire time while worn for two days The recordings from the EAR will provide information about your daily activities The study staff will make a written copy of what is said on the recordings for analysis Before returning the EAR device you will be given the opportunity to schedule an appointment where you can listen to the recordings and erase any portion that you think is embarrassing or private If participants have no concerns about the EAR recordings the EAR can be returned in a prepaid mailing packet After wearing the EAR you will complete an evaluation questionnaire over the phone which will take about 5 minutes
You will complete the questionnaires when you enter the study 2 months after entering the study and 4 months after entering the study You also will be asked to wear the EAR for 2 days when you enter the study and for 2 days at 4 months after entering the study
You will be assigned randomly as in the toss of a coin to one of two programs the Expressive Disclosure Group Program or the Standard Care Program
Patients in the Expressive Disclosure Group Program will attend groups with about 11 members The program will include 12 group meetings over the course of 4months 9 weekly meetings 2 semi-monthly twice a month meetings and a final meeting in month 4 Each meeting will last 1 hour This program will involve talking and writing about several topics that are important for individuals facing colon and rectal cancer Participants in this program also will receive written educational material and information about community resources Group meetings will be audio-taped Copies of tapes will be provided to participants when they miss a session Tapes will sometimes be reviewed by project investigators to make sure the groups are covering the program content
Patients in the Standard Care Program will not attend any formal group meetings They will receive by mail written educational material and information about community resources
This is an investigational study A total of 149 individuals diagnosed with colon or rectal cancer will take part in this study 131 from M D Anderson and 18 from Kelsey-Seybold Clinics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21CA107306-01A2 | NIH | None | httpsreporternihgovquickSearch1R21CA107306-01A2 |