Psychological Interventions for Gynecologic Cancer
Přehled studie
Detailní popis
Very little is known in the psycho-oncology literature about why psychological interventions are effective or for how long these interventions exert an impact. Given many cancer patients experience recurrence and/or progression, it is important to know whether our relatively brief interventions facilitate how patients cope with this most-feared medical event. From a theoretical perspective, the study will advance our understanding of the mechanisms for change for two common treatment approaches, supportive and cognitive behavioral therapies.
Subjects will be enrolled and upon completion of a baseline survey, randomized to into one of three arms - Communication Skills Intervention, Supportive Counseling, and Usual Care. Subjects will complete surveys during the course of the interventions.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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New Jersey
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Camden, New Jersey, Spojené státy, 08103
- Cooper Health System
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Hamilton, New Jersey, Spojené státy, 08690
- Cancer Institute of New Jersey at Hamilton
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Morristown, New Jersey, Spojené státy, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, Spojené státy, 08903
- Rutgers Cancer Institute of New Jersey
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New York
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New York, New York, Spojené státy, 10022
- Memorial Sloan Kettering Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Spojené státy, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, Spojené státy, 19107
- Jefferson University School of Medicine
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Philadelphia, Pennsylvania, Spojené státy, 19111
- University of Pennsylvania Health System
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Newly diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer in the past 6 months
- Newly diagnosed with High Grade Stage 2, any grade Stage 3 or higher endometrial cancer in the past 6 months
- Newly diagnosed with Stage 2 or higher cervical cancer withing the past 6 months
- Newly diagnosed with any stage of Uterine cancer (both sarcoma and carcinosarcoma) in the past 6 months
- At the time of recruitment, the patient is on active treatment defined as either currently receiving chemotherapy or radiation or less than 6 months post-cancer surgery
- At the time of recruitment, a Karnofsky Performance Status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- English speaking
- Lives within a two-hour commuting distance from the recruitment site
- No hearing impairment
- Has signed consent within 6 months of diagnosis date
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Coping & Communication Skills
The CCI intervention focuses on bolstering stress management and problem solving abilities, identifying and expressing support needs constructively, facilitating the ability to cope with unchangeable issues, cognitive restructuring, and dealing effectively with body image and sexuality issues over seven weekly 60 minute sessions.
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Experimentální: Supportive Counseling (SC)
The SC intervention incorporates a supportive, non-directive counseling approach in seven weekly 60 minute sessions
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Žádný zásah: Usual Care (UC)
Patients receive standard psychological and emotional care (usual care [UC]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Do the two psychological interventions, CCI and SC, result in greater improvements in global psychological adaptation
Časové okno: 7 years
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Global Psychological distress: Depressive symptoms - The BDI is a 21-item scale which has been widely used in studies incorporating cognitive-behavioral interventions.The MHI-18 has subscales for Psychological Distress and Well-being. |
7 years
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Do the two psychological interventions, CCI and SC, result in greater improvements in cancer-specific psychological adaptation
Časové okno: 7 years
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Cancer-Specific Distress: Traumatic Stress. The Impact of Events Scale (IES) is a 15-item self-report measure focusing on intrusive and avoidant ideation related to gynecologic cancer and its treatment. Using a 4-point Likert scale, participants rated how true each statement has been for them during the past week (scale range = 0-75). Fear of Recurrence/Progression. The Concerns about Recurrence Scale (CARS) is a 26 item assessment of the nature of women's fears about cancer recurrence. |
7 years
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Do the two psychological interventions, CCI and SC, result in greater improvements in quality of life
Časové okno: 7 years
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Quality of Life-General. The Functional Assessment of Cancer Therapy - General (FACT-G) is a widely used measure of QOL. The FACT-G is comprised of 27 questions that assess well-being in four domains: physical, functional, social/family, and emotional. Spiritual well-being. The FACIT Spiritual well-being scale assesses a sense of meaning in life, harmony, peacefulness, sense of strength, and comfort from one's faith. The 12 item scale has two factors: Meaning/Peace and Faith. |
7 years
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 130909
- R01CA085566-06A1 (Grant/smlouva NIH USA)
- NCI-2012-00551 (Jiný identifikátor: CTRP (Clinical Trails Reporting Program))
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