Prostate CancerNCT00798187
Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn if a support group program is acceptable for patients with prostate cancer or patients with breast cancer. Researchers also want to learn if the characteristics of the members of the support group program can have an effect on the quality of life of other members of the… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Group Meetings and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to 26 Mar 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants, 21 years of age or older, diagnosed with Prostate Cancer or Breast Cancer.
Who may be able to join
- Diagnosis of prostate or breast cancer, regardless of treatment
- No evidence of metastatic disease
- Able to read, speak, and write English
- Resides within one hour of M.D. Anderson Cancer Center
- 21 years of age or older
- Able to provide meaningful informed consent as judged by a research team member
- Being a distressed patient: a T score greater than or equal to 63 on the Global Severity Index (GSI) of the Brief Symptom Inventory (BSI) or a T score greater than or equal to 63 on any two primary dimensions of this measure, or being a non-distressed patient: a T score of < 63 on the GSI and a T score of <63 on all primary dimensions of the BSI.
Who cannot join
- 1) None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to learn if a support group program is acceptable for patients with prostate cancer or patients with breast cancer. Researchers also want to learn if the characteristics of the members of the support group program can have an effect on the quality of life of other members of the support group program. Support group programs will be conducted separately for prostate cancer patients and breast cancer patients.
Read the detailed description
Screening Questionnaires:
Signing this consent form does not mean that you will be able to take part in this study. You will complete some questions about your mood to help researchers decide if you are eligible to take part in this study. It will take 10 to 15 minutes to complete these questions.
The researcher will discuss the questionnaire results with you and provide you with a list of community referrals and resources.
If your responses to the questions show that you are distressed, you will be eligible to take part in this study. If your responses to the questions show that you are not distressed, you will be randomly selected (as in the flip of a coin) to take part in this study.
If your responses to the questions show that you may harm yourself, a licensed psychologist will follow-up with you and make recommendations for future treatment.
Study Questionnaires:
If you are found to be eligible and are selected to take part in this study, you will be asked to complete questionnaires that will have questions about your medical history, quality of life, mood, thought processes, methods of coping with the disease, and support that you receive from others. It will take about 1 hour to complete these questionnaires.
Support Groups:
You will also take part in a support group program for either prostate or breast cancer patients. Each support group will be made up of about 10 members. Each group will meet 1 time each week for 10 weeks. Each meeting will last about 2 hours. At each meeting, patients will discuss and learn about methods of coping with the disease and ways to relax.
All meetings will be audio-recorded. Recordings will be reviewed by the research team to make sure that the groups are covering the program content.
Length of Study:
You will be on study for about 3 months.
End-of Study Questionnaires:
After the last support group meeting, you will complete questionnaires that will ask questions about your medical history, quality of life, mood, thought processes, methods of coping with the disease, and support that you receive from others. You will be off study after you have completed the end-of-study questionnaires.
This is an investigational study.
Up to 240 patients will take part in this study. Up to 204 will be enrolled at MD Anderson.
- Conditions
- Prostate Cancer
- Being tested
- Group Meetings, Questionnaire
- Keywords
- Prostate Cancer, Breast Cancer, Behavioral Intervention, Cancer Support Programs, Social Comparison, Heterogeneous support group, Homogeneous support group
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group MeetingsBehavioural
10 weekly group meetings lasting 2 hours.
QuestionnaireBehavioural
Surveys
| Study group | Role | What they receive |
|---|---|---|
| Homogeneous Support Group | Not described Receives: Behavioral: Group Meetings; Behavioral: Questionnaire | |
| Heterogeneous Support Group One | Not described Receives: Behavioral: Group Meetings; Behavioral: Questionnaire | |
| Heterogeneous Support Group Two | Not described Receives: Behavioral: Group Meetings; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Psychological Functioning and Quality of Life (QOL)
Measured: Baseline and Month 3: Questionnaires & Support Group Assessments
Secondary outcomes (1)
To study if the characteristics of the members of the support group program can have an effect on the quality of life of other members of the support group program.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startMay 2009
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Why it stopped: Terminated at time of CR - 3.26.2019 - JA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 240 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 Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798187
- Sponsor's protocol ID
- 2008-0594
- Other IDs
- 1R21CA126854
- Status last verified
- May 2019
- First submitted
- 24 Nov 2008
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis
- ClinicalTrials.gov ID
- NCT00798187
- Acronym / sponsor ID
- 2008-0594
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Breast Cancer, Behavioral Intervention, Cancer Support Programs, Social Comparison, Heterogeneous support group, Homogeneous support group
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated at time of CR - 3.26.2019 - JA
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2009 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 26 Nov 2008 (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.
The goal of this research study is to learn if a support group program is acceptable for patients with prostate cancer or patients with breast cancer. Researchers also want to learn if the characteristics of the members of the support group program can have an effect on the quality of life of other members of the support group program. Support group programs will be conducted separately for prostate cancer patients and breast cancer patients.
Detailed description
Screening Questionnaires:
Signing this consent form does not mean that you will be able to take part in this study. You will complete some questions about your mood to help researchers decide if you are eligible to take part in this study. It will take 10 to 15 minutes to complete these questions.
The researcher will discuss the questionnaire results with you and provide you with a list of community referrals and resources.
If your responses to the questions show that you are distressed, you will be eligible to take part in this study. If your responses to the questions show that you are not distressed, you will be randomly selected (as in the flip of a coin) to take part in this study.
If your responses to the questions show that you may harm yourself, a licensed psychologist will follow-up with you and make recommendations for future treatment.
Study Questionnaires:
If you are found to be eligible and are selected to take part in this study, you will be asked to complete questionnaires that will have questions about your medical history, quality of life, mood, thought processes, methods of coping with the disease, and support that you receive from others. It will take about 1 hour to complete these questionnaires.
Support Groups:
You will also take part in a support group program for either prostate or breast cancer patients. Each support group will be made up of about 10 members. Each group will meet 1 time each week for 10 weeks. Each meeting will last about 2 hours. At each meeting, patients will discuss and learn about methods of coping with the disease and ways to relax.
All meetings will be audio-recorded. Recordings will be reviewed by the research team to make sure that the groups are covering the program content.
Length of Study:
You will be on study for about 3 months.
End-of Study Questionnaires:
After the last support group meeting, you will complete questionnaires that will ask questions about your medical history, quality of life, mood, thought processes, methods of coping with the disease, and support that you receive from others. You will be off study after you have completed the end-of-study questionnaires.
This is an investigational study.
Up to 240 patients will take part in this study. Up to 204 will be enrolled at MD Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Homogeneous Support Group | – | Behavioral: Group Meetings, Behavioral: Questionnaire |
| Heterogeneous Support Group One | – | Behavioral: Group Meetings, Behavioral: Questionnaire |
| Heterogeneous Support Group Two | – | Behavioral: Group Meetings, Behavioral: Questionnaire |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants, 21 years of age or older, diagnosed with Prostate Cancer or Breast Cancer.
Key inclusion criteria (7 listed)
- Diagnosis of prostate or breast cancer, regardless of treatment
- No evidence of metastatic disease
- Able to read, speak, and write English
- Resides within one hour of M.D. Anderson Cancer Center
- 21 years of age or older
Key exclusion criteria (1 listed)
- 1) None
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 |
|---|---|---|
| Group Meetings10 weekly group meetings lasting 2 hours. | Behavioural | Heterogeneous Support Group One, Heterogeneous Support Group Two, Homogeneous Support Group |
| QuestionnaireSurveys | Behavioural | Heterogeneous Support Group One, Heterogeneous Support Group Two, Homogeneous Support Group |
Primary outcome
Patient Psychological Functioning and Quality of Life (QOL)
Time frame: Baseline and Month 3: Questionnaires & Support Group Assessments
1 secondary outcome
To study if the characteristics of the members of the support group program can have an effect on the quality of life of other members of the support group program.
Time frame: 2 Years
Results and safety
The study was stopped early (reason given: Terminated at time of CR - 3.26.2019 - JA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site 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 7 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Terminated at time of CR - 3.26.2019 - JA). 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?
Patient Psychological Functioning and Quality of Life (QOL) (time frame: Baseline and Month 3: Questionnaires & Support Group Assessments). 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 15 May 2019.