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Healing Touch or Guided Imagery In Treating Pain, Fatigue, Nausea, and Anxiety in Patients Undergoing Chemotherapy

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ClinicalTrials.gov Identifier: NCT01553578
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
This randomized clinical trial studies healing touch or guided imagery in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy. Healing touch and guided imagery may help treat complications caused by chemotherapy. It is not yet known whether healing touch or guided imagery is more effective in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy

Condition or disease Intervention/treatment Phase
Anxiety Disorder Fatigue Malignant Neoplasm Nausea and Vomiting Pain Other: questionnaire administration Procedure: therapeutic touch Behavioral: management of therapy complications Procedure: standard follow-up care Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if the provision of healing touch or guided imagery during outpatient chemotherapy is associated with decreased pain, fatigue, nausea and anxiety when compared to standard outpatient treatment protocols.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A: Patients receive 30 minutes of healing touch therapy comprising magnetic clearing, pain drains, hands in motion/hands still and mind clearing.

ARM B: Patients listen to guided imagery audiotapes for 30 minutes

ARM C: Patients receive standard of care.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Efficacy of Healing Touch Versus Guided Imagery on Pain, Fatigue, Nausea, and Anxiety in Patients' Receiving Outpatient Chemotherapy
Study Start Date : February 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A (healing touch therapy)
Patients receive 30 minutes of healing touch therapy consisting of magnetic clearing, pain drains, hands in motion/hands still and mind clearing.
Other: questionnaire administration
Ancillary studies

Procedure: therapeutic touch
Receive healing touch therapy
Other Name: healing touch

Behavioral: management of therapy complications
Receive healing touch therapy
Other Name: complications of therapy, management of

Experimental: Arm B (guided imagery)
Patients listen to guided imagery audiotapes for 30 minutes.
Other: questionnaire administration
Ancillary studies

Behavioral: management of therapy complications
Receive guided imagery audiotapes
Other Name: complications of therapy, management of

Active Comparator: Arm C (standard care)
Patients receive standard of care.
Other: questionnaire administration
Ancillary studies

Procedure: standard follow-up care
Receive standard care




Primary Outcome Measures :
  1. Change scores for each patient on pain scale [ Time Frame: Approximately 6 months ]
    Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.

  2. Change scores for each patient on fatigue scale [ Time Frame: Approximately 6 months ]
    Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.

  3. Change scores for each patient on nausea scale [ Time Frame: Approximately 6 months ]
    Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.

  4. Change scores for each patient on anxiety scale [ Time Frame: Approximately 6 months ]
    Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients at the outpatient chemotherapy area will be enrolled without consideration for type of cancer or chemotherapeutic agents to be used

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553578


Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lisa Hodges Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01553578     History of Changes
Other Study ID Numbers: CCCWFU 97511
NCI-2012-00164 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2015

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anxiety Disorders
Fatigue
Nausea
Vomiting
Neoplasms
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive