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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01177 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R21CA135005 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.
PRIMARY OBJECTIVES:
I. To refine the intervention. II. Test the acceptability, feasibility, and clinical appropriateness of the intervention.
III. To provide a preliminary test of its efficacy.
OUTLINE:
Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising mindfulness-based stress reduction (MBSR), an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.
After completion of study treatment, patients are followed up at 28 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (psychosocial intervention) | Experimental | Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising MBSR, an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | Ancillary studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life(QoL) | Quality of life as assessed by Short Form (SF)-36 | up to 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mood as assessed by the Profile of Mood States (POMS) | Up to 28 weeks | |
| Depressive symptoms as assessed by the Center for Epidemiological Studies, Depression scale (CES-D) | Up to 28 weeks | |
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Inclusion Criteria:
Diagnosis of recurrent breast or gynecologic cancer (any site) with any disease-free interval; second primary cancers do not meet this criterion
English speaking
Able and willing to give informed consent
To be considered for the blood and saliva collection, women must fulfill the following secondary criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Andersen, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| quality-of-life assessment |
| Procedure |
Patients will participate in a quality life assessment. |
|
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| psychosocial assessment and care | Procedure | Participate in multi-component biobehavioral intervention |
|
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| behavioral intervention | Behavioral | Participate in multi-component biobehavioral intervention |
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| cognitive intervention | Other | A multi-component intervention based on cognitive and behavioral principles will be used. It combines effective intervention strategies selected for their relevance to patients with recurrent cancer. |
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| educational intervention | Other | Participate in multi-component biobehavioral intervention |
|
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| Stress as assessed by the Impact of Event Scale (IES) |
| Up to 28 weeks |
| Pain as assessed by the Brief Pain Inventory (BPI) | Up to 28 weeks |
| Fatigue as assessed by the Fatigue Severity Index (FSI) | Up to 28 weeks |
| Diurnal cortisol slope | Study participants will also collect saliva samples at home 4 times a day for 3 days. Saliva samples will be collected at the baseline, mid-treatment, post-treatment and 3-month follow-up assessments. These samples will be used to measure cortisol. | Up to 28 weeks |
| Inflammation | Blood samples will be used to measure levels of inflammatory markers. Blood draws will be coordinated with the participants' regularly scheduled blood draws to minimize discomfort. | Up to 28 weeks |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D005221 | Fatigue |
| D007984 | Leydig Cell Tumor |
| D010146 | Pain |
| D010534 | Peritoneal Neoplasms |
| D011553 | Pseudomyxoma Peritonei |
| D001943 | Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D031901 | Gestational Trophoblastic Disease |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018310 | Sertoli-Leydig Cell Tumor |
| D018312 | Sex Cord-Gonadal Stromal Tumors |
| D018309 | Neoplasms, Gonadal Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013736 | Testicular Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D009461 | Neurologic Manifestations |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D002288 | Adenocarcinoma, Mucinous |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
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| ID | Term |
|---|---|
| D000067250 | Psychiatric Rehabilitation |
| D001521 | Behavior Therapy |
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
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