NCT00798187

Brief 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 support group program. Support group programs will be conducted separately for prostate cancer patients and breast cancer patients.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

9.9 years

First QC Date

November 24, 2008

Last Update Submit

May 13, 2019

Conditions

Keywords

Prostate CancerBreast CancerBehavioral InterventionCancer Support ProgramsSocial ComparisonHeterogeneous support groupHomogeneous support group

Outcome Measures

Primary Outcomes (1)

  • Patient Psychological Functioning and Quality of Life (QOL)

    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.

    2 Years

Study Arms (3)

Homogeneous Support Group

Behavioral: Group MeetingsBehavioral: Questionnaire

Heterogeneous Support Group One

Behavioral: Group MeetingsBehavioral: Questionnaire

Heterogeneous Support Group Two

Behavioral: Group MeetingsBehavioral: Questionnaire

Interventions

Group MeetingsBEHAVIORAL

10 weekly group meetings lasting 2 hours.

Heterogeneous Support Group OneHeterogeneous Support Group TwoHomogeneous Support Group
QuestionnaireBEHAVIORAL

Surveys

Heterogeneous Support Group OneHeterogeneous Support Group TwoHomogeneous Support Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • \) None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsBreast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Cindy L Carmack Taylor, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 26, 2008

Study Start

May 1, 2009

Primary Completion

March 26, 2019

Study Completion

March 26, 2019

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations