Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- University of Texas MD Anderson Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
1) None
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Homogeneous Support Group
|
10 weekly group meetings lasting 2 hours.
Surveys
|
|
Heterogeneous Support Group One
|
10 weekly group meetings lasting 2 hours.
Surveys
|
|
Heterogeneous Support Group Two
|
10 weekly group meetings lasting 2 hours.
Surveys
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Patient Psychological Functioning and Quality of Life (QOL)
Lasso di tempo: Baseline and Month 3: Questionnaires & Support Group Assessments
|
Baseline and Month 3: Questionnaires & Support Group Assessments
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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.
Lasso di tempo: 2 Years
|
2 Years
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Cindy L Carmack Taylor, PHD, M.D. Anderson Cancer Center
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2008-0594
- 1R21CA126854 (Sovvenzione/contratto NIH degli Stati Uniti)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .