Psychological Interventions for Gynecologic Cancer
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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New Jersey
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Camden, New Jersey, Förenta staterna, 08103
- Cooper Health System
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Hamilton, New Jersey, Förenta staterna, 08690
- Cancer Institute of New Jersey at Hamilton
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Morristown, New Jersey, Förenta staterna, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, Förenta staterna, 08903
- Rutgers Cancer Institute of New Jersey
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New York
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New York, New York, Förenta staterna, 10022
- Memorial Sloan Kettering Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Förenta staterna, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, Förenta staterna, 19107
- Jefferson University School of Medicine
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Philadelphia, Pennsylvania, Förenta staterna, 19111
- University of Pennsylvania Health System
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Experimentell: Supportive Counseling (SC)
The SC intervention incorporates a supportive, non-directive counseling approach in seven weekly 60 minute sessions
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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Do the two psychological interventions, CCI and SC, result in greater improvements in global psychological adaptation
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 130909
- R01CA085566-06A1 (U.S.S. NIH-anslag/kontrakt)
- NCI-2012-00551 (Annan identifierare: CTRP (Clinical Trails Reporting Program))
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Kliniska prövningar på Psykoterapi
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Boston CollegeNational Institute of Mental Health (NIMH)RekryteringKunskap, attityder, praktikFörenta staterna
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Yale UniversityNational Institute of Mental Health (NIMH)AvslutadSexuell minoritetsstressFörenta staterna