Colorectal CancerNCT00853203
Expressive Disclosure and Colorectal Cancer
An observational study of Colorectal Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Interviews, Questionnaires and Electronically Activated Recorder (EAR)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 174 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population of 174 participants diagnosed with colorectal cancer.
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kelsey-Seybold Clinics
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Expressive Disclosure Program for Colorectal Cancer Patients
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).
Read more
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.
Read the 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 12.5 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 M.D. 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 M.D. Anderson and/or 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 12.5 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.
- Conditions
- Colorectal Cancer
- Being tested
- Interviews, Questionnaires, Electronically Activated Recorder (EAR), Group Meetings, Written Materials
- Keywords
- Colorectal Cancer, Rectal Cancer, Psychosocial, Expressive Disclosure, Questionnaires, Quality of life, QOL, Electronically Activated Recorder, EAR
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsBehavioural
Also called Questionnaires
Open-ended Interviews, audiotaped, lasting 30 minutes to 1 hour.
QuestionnairesBehavioural
Written survey taking about 1 hour.
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.
Group MeetingsBehavioural
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.
Written MaterialsBehavioural
Written educational materials plus community resource information.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Interviews + Questionnaire + Electronically Activated Recorder (EAR) Receives: Behavioral: Interviews; Behavioral: Questionnaires; Other: Electronically Activated Recorder (EAR) | |
| Part 2, Expressive Disclosure Group | Group Meetings + Written Materials Receives: Behavioral: Questionnaires; Behavioral: Group Meetings; Behavioral: Written Materials | |
| Part 2, Standard Care Control Group | Written Materials Receives: Behavioral: Questionnaires; Behavioral: Written Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect information about factors affecting colon and rectal cancer patients' quality of life (QOL) in order to develop a QOL program.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cindy L. Carmack Taylor, PHD, Principal investigator, M.D. Anderson Cancer CenterKaren Basen-Engquist, PHD, BA, MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853203
- Sponsor's protocol ID
- 2003-1028
- Other IDs
- 1R21CA107306-01A2
- Status last verified
- Dec 2020
- First submitted
- 27 Feb 2009
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressive Disclosure Program for Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT00853203
- Acronym / sponsor ID
- 2003-1028
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Rectal Cancer, Psychosocial, Expressive Disclosure, Questionnaires, Quality of life, QOL, Electronically Activated Recorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2009 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 12.5 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 M.D. 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 M.D. Anderson and/or 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 12.5 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | – | Behavioral: Interviews, Behavioral: Questionnaires, Other: Electronically Activated Recorder (EAR)Interviews + Questionnaire + Electronically Activated Recorder (EAR) |
| Part 2, Expressive Disclosure Group | – | Behavioral: Questionnaires, Behavioral: Group Meetings, Behavioral: Written MaterialsGroup Meetings + Written Materials |
| Part 2, Standard Care Control Group | – | Behavioral: Questionnaires, Behavioral: Written MaterialsWritten Materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population of 174 participants diagnosed with colorectal cancer.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (4 listed)
- 1. Not being able to provide informed consent.
- 1. Not being able to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewsAlso: QuestionnairesOpen-ended Interviews, audiotaped, lasting 30 minutes to 1 hour. | Behavioural | Part 1 |
| QuestionnairesWritten survey taking about 1 hour. | Behavioural | Part 1, Part 2, Expressive Disclosure Group, Part 2, Standard Care Control Group |
| 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. | Other | Part 1 |
| Group Meetings12 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. | Behavioural | Part 2, Expressive Disclosure Group |
| Written MaterialsWritten educational materials plus community resource information. | Behavioural | Part 2, Expressive Disclosure Group, Part 2, Standard Care Control Group |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L. Carmack Taylor, PHD principal investigator
M.D. Anderson Cancer Center
Karen Basen-Engquist, PHD, BA, MPH principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.