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Cancer Support Programs

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00798187
First received: November 24, 2008
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Behavioral: Group Meetings
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Psychological Functioning and Quality of Life (QOL) [ Time Frame: Baseline and Month 3: Questionnaires & Support Group Assessments ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: May 2009
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Homogeneous Support Group Behavioral: Group Meetings
10 weekly group meetings lasting 2 hours.
Behavioral: Questionnaire
Surveys
Heterogeneous Support Group One Behavioral: Group Meetings
10 weekly group meetings lasting 2 hours.
Behavioral: Questionnaire
Surveys
Heterogeneous Support Group Two Behavioral: Group Meetings
10 weekly group meetings lasting 2 hours.
Behavioral: Questionnaire
Surveys

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants, 21 years of age or older, diagnosed with Prostate Cancer or Breast Cancer.

Criteria

Inclusion Criteria:

  1. Diagnosis of prostate or breast cancer, regardless of treatment
  2. No evidence of metastatic disease
  3. Able to read, speak, and write English
  4. Resides within one hour of M.D. Anderson Cancer Center
  5. 21 years of age or older
  6. Able to provide meaningful informed consent as judged by a research team member
  7. 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.

Exclusion Criteria:

1) None

  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: NCT00798187

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Cindy L Carmack Taylor, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00798187     History of Changes
Other Study ID Numbers: 2008-0594, 1R21CA126854
Study First Received: November 24, 2008
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Breast Cancer
Behavioral Intervention
Cancer Support Programs
Social Comparison
Heterogeneous support group
Homogeneous support group

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014