| Primary | Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) | Measured by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life. | | Posted | Oct 2011 | Mean | Full Range | Scores on a Scale | | Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy | | | | ID | Title | Description |
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| OG000 | Chemotherapy Alone | Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. | | OG001 | Chemotherapy + CAM | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). |
| | | Title | Denominators | Categories |
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| Prior to Cycle 1 | | | Title | Measurements |
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| - OG000143(121 to 200)
- OG001152(138 to 187)
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| | Prior to Cycle 3 | | |
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| Primary | Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM | The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240). | | Posted | Oct 2011 | Mean | Full Range | Scores on a scale | | Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy | | | | ID | Title | Description |
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| OG000 | Chemotherapy Alone | Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. | | OG001 | Chemotherapy + CAM | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). |
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| Secondary | Number of Patients With Delays In Receiving Chemotherapy Alone | Number of patients who had to delay their chemotherapy treatments due to side effects. | | Posted | | Number | | participants | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Alone | Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. |
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| Secondary | Number of Patients With Delays In Receiving Chemotherapy Plus CAM | Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects. | | Posted | | Number | | Participants | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Plus CAM | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). |
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| Secondary | Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone | Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy. | Patients that received 6 cycles of chemotherapy alone. | Posted | | Mean | Standard Deviation | Prescriptions per participant | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Alone | Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. |
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| Secondary | Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM | Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine. | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). | Posted | | Mean | Standard Deviation | Prescriptions per participant | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Plus CAM | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). |
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| Secondary | Average Anti-Emetic Dose Use After Chemotherapy Alone | Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient. | | Posted | | Mean | Standard Deviation | Dose (mg) per participant | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Alone | Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. |
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| Secondary | Average Anti-Emetic Dose Use After Chemotherapy Plus CAM | Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine. | | Posted | | Mean | Standard Deviation | Dose (mg) per participant | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Plus CAM | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). |
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| Secondary | Average Natural Killer Cell Count Levels Before Chemotherapy Alone | Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb. | | Posted | | Mean | Full Range | Cells per mm^3 | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Alone | Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. |
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| Secondary | Average Natural Killer Cell Count Levels Before Chemotherapy and CAM | Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb. | | Posted | | Mean | Full Range | Cells per mm^3 | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Plus CAM | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). |
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| Secondary | Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM | Number of patients that had infections requiring antibiotic therapy or admission to the hospital that received either chemotherapy alone or chemotherapy plus complementary alternative medicine. | | Posted | Oct 2011 | Number | | Participants | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Alone | Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. | | OG001 | Chemotherapy + CAM | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). |
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| Secondary | Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM | Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine. | | Posted | Oct 2011 | Number | | Participants | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
|---|
| OG000 | Chemotherapy Alone | Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. | | OG001 | Chemotherapy + CAM | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). |
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| Secondary | Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM | Determined from white blood cell counts collected during treatment phase of study; average applied. | | Posted | Oct 2011 | Mean | Standard Deviation | cells/mm^3 | | Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Alone | Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. | | OG001 | Chemotherapy + CAM | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). |
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| Secondary | Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM | Average count determined - collected during treatment phase of study - Includes T-helper/inducer, CD4 and CD8 cells; number of CD4 and CD8 cells (in mm^3). | | Posted | Oct 2011 | Mean | Standard Deviation | cells/mm^3 | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Alone | Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. | | OG001 | Chemotherapy + CAM | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). |
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| Secondary | Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM | Determined from collection of saliva during treatment phase of study and recorded in mg/dL units. | | Posted | Oct 2011 | Mean | Standard Deviation | mg/dL | | Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days) | | | | ID | Title | Description |
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| OG000 | Chemotherapy Alone | Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician. | | OG001 | Chemotherapy + CAM | Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy). |
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