Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
NCT ID: NCT00293293
Last Updated: 2017-12-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2005-05-31
2010-01-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well giving hypnosis, massage therapy and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed epithelial ovarian, fallopian tube or peritoneal cavity cancer.
Detailed Description
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Primary
* Determine whether quality of life is improved in patients with epithelial ovarian, fallopian tube or primary peritoneal cavity cancer receiving hypnosis, massage therapy, and healing touch and standard chemotherapy as compared to patients receiving standard chemotherapy alone.
Secondary
* Determine changes in immunologic response markers, chemotherapy side effects, and complication rates in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
* Arm I (standard therapy): Patients undergo standard chemotherapy for epithelial ovarian, fallopian tube or primary peritoneal cancer.
* Arm II (standard therapy with complementary alternative medicine): Patients undergo chemotherapy as in arm I. Patients also undergo massage over approximately 30 minutes and healing touch therapy over approximately 30 minutes with each course of chemotherapy 1-6 and hypnosis over 30-60 minutes during courses 1, 2, and 4.
Quality of life is assessed at baseline, during courses 3 and 6 of chemotherapy, and then 6 months after completion of study treatment.
After completion of study treatment, patients are followed at 6 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Chemotherapy Alone
Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or primary peritoneal cancer by their treating physician. Chemotherapy administration is not administered as part of this protocol.
Standard chemotherapy
Patients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study.
Standard Chemotherapy + CAM
Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or peritoneal cancer with additional complementary alternative medicine - CAM (healing touch, hypnosis and massage therapy). Chemotherapy administration is not administered as part of this protocol.
healing touch
The practitioner performed a structured interview with the patient both a verbal assessment and an energy/physical assessment using pendulum and hand scan techniques. The practitioner will then provide the intervention which will consist of: chakra connection, magnetic passes (hands still and in motion), magnetic clearing.
massage therapy
Standard massage techniques will be employed over the head, neck, shoulders, back, hands, and/or feet areas. The intensity and rapidity of massage movements will be individualized to the patient's comfort level.
hypnosis
Steps: 1) begins with a progressive relaxation induction; 2) suggestions for deepening are then provided; 3) offered suggestions to increase comfort with medical procedures; 4) suggestion for enhanced capacity for coping will be given as an ego strengthening suggestion, with a post-hypnotic suggestion for increasing comfort/success in coping each time.
Interventions
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healing touch
The practitioner performed a structured interview with the patient both a verbal assessment and an energy/physical assessment using pendulum and hand scan techniques. The practitioner will then provide the intervention which will consist of: chakra connection, magnetic passes (hands still and in motion), magnetic clearing.
massage therapy
Standard massage techniques will be employed over the head, neck, shoulders, back, hands, and/or feet areas. The intensity and rapidity of massage movements will be individualized to the patient's comfort level.
hypnosis
Steps: 1) begins with a progressive relaxation induction; 2) suggestions for deepening are then provided; 3) offered suggestions to increase comfort with medical procedures; 4) suggestion for enhanced capacity for coping will be given as an ego strengthening suggestion, with a post-hypnotic suggestion for increasing comfort/success in coping each time.
Standard chemotherapy
Patients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have signed an informed consent
Exclusion Criteria
* Previous chemotherapy experience
* Active substance abuse
* Schizophrenia
* Pregnant or lactating
FEMALE
No
Sponsors
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Randy Shaver Cancer Research Fund
UNKNOWN
Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Patricia L. Judson, MD
Role: STUDY_CHAIR
Moffitt
Locations
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Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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UMN-WCC-30
Identifier Type: OTHER
Identifier Source: secondary_id
0012M77821
Identifier Type: OTHER
Identifier Source: secondary_id
2000NT790
Identifier Type: -
Identifier Source: org_study_id