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Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer

21. září 2016 aktualizováno: Michael F. Scheier, Carnegie Mellon University

Adjustment to Breast Cancer Among Younger Women

RATIONALE: Educational programs may improve coping and quality of life in younger women who have recently been treated for early-stage breast cancer.

PURPOSE: To conduct a clinical trial to determine if an educational intervention and a nutritional intervention could enhance physical and psychological functioning among younger women completing treatment for early-stage breast cancer.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

OBJECTIVES:

  • Design, implement, and evaluate an educational intervention and a nutrition education intervention specifically aimed at improving adjustment among younger women who have been newly diagnosed with and treated for stage I or II breast cancer and who are ending the active phase of treatment.
  • Determine the processes through which the interventions affect quality of life.
  • Assess whether the interventions are differentially effective for different groups of women.
  • Determine how women who decline participation differ from those who participate.
  • Determine the nature and extent of adjustment difficulties, using baseline data, in younger women living in an urban setting who have been treated for early stage breast cancer.
  • Identify personality and situational correlates of individuals who adapt well to early-stage breast cancer diagnosis and treatment and those who do not.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 intervention groups or a control condition.

  • Arm I (control group): Patients did not undergo any intervention. Patients were evaluated at baseline and at 4 and 13 months.
  • Arm II (breast cancer education group): Patients attended a series of approximately 2-hour-long breast cancer education group sessions once a month for 4 months. Sessions involved the presentation of information concerning breast cancer, followed by a guided discussion of related topics. Sessions topics included: talking with children about cancer, life after diagnosis, relationships/intimacy, and hormones and breast cancer/basic factors of heredity. Patients were also given booklets and brochures to read at home. Patients were evaluated at baseline, immediately after the intervention, and at 9 months after the intervention.
  • Arm III (nutritional education group): Patients attended a series of approximately 2-hour-long nutritional education group sessions once a month for 4 months. Sessions involved the presentation of information concerning nutrition, followed by a guided discussion of related topics. Session topics included: healthy cupboards, what's cooking, shopping for success, and out on the town. Patients were also asked to keep a 4 day record of diet. Patients were evaluated at baseline, immediately after the intervention, and at 9 months after the intervention.

Typ studie

Intervenční

Zápis (Aktuální)

252

Fáze

  • Nelze použít

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 49 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

INCLUSION CRITERIA (Disease Characteristics):

  • Diagnosis of breast cancer

    • Stage I or II disease
    • No more than 10 positive lymph nodes
    • First-time diagnosis
    • Under the age of 50 at diagnosis
  • Finished active treatment within the past 2 months
  • English-speaking only
  • Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania

INCLUSION CRITERIA (Patient Characteristics):

  • Female patients only
  • Must be able to communicate

EXCLUSION CRITERIA (Patient Characteristics):

  • Other prior malignancies except skin cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Education Intervention
Participants attended 4 2-hr education sessions. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness and its treatment, to enhance coping in productive ways with the issues and problems confronting them, and to facilitate communication between the participants and their partners.
Behaviorální: Education Intervention
Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer and how to create a safe environment for them; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read.
Experimentální: Nutrition Education Intervention
Participants attended 4 2-hr nutrition education sessions. Each session provided information and encouragement on setting and attaining measurable goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems in life and living a healthy lifestyle.
Behaviorální: Nutrition Education Intervention
The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it.
Žádný zásah: Control Condition
Participants received care as usual.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).
Časové okno: Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).
Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.
Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).
Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
Časové okno: Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)
The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: Physical functioning, bodily pain, role limitations due to physical problems and general health. In the present study, scores ranged from a maximum of 68 (high levels of perceived health) to a minimum of 24 (low levels of perceived health).
Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)
Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
Časové okno: Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)
The Mental Health Component Scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: vitality, social functioning, role limitations due to emotional problems and mental health. In the present study, scores ranged from a maximum of 68 (high levels of mental health) to a minimum of 15 (low levels of mental health).
Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Carnegie Mellon University

Spolupracovníci

National Cancer Institute (NCI)

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. ledna 1997

Primární dokončení (Aktuální)

1. května 2001

Dokončení studie (Aktuální)

1. dubna 2006

Termíny zápisu do studia

První předloženo

27. prosince 2006

První předloženo, které splnilo kritéria kontroly kvality

27. prosince 2006

První zveřejněno (Odhad)

28. prosince 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

6. listopadu 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. září 2016

Naposledy ověřeno

1. září 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CMU-00000603 (cmu)
  • 5R01CA064711 (Grant/smlouva NIH USA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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