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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01553578
First received: March 9, 2012
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Change scores for each patient on pain scale [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
    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.

  • Change scores for each patient on fatigue scale [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
    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.

  • Change scores for each patient on nausea scale [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
    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.

  • Change scores for each patient on anxiety scale [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01553578

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Lisa Hodges Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01553578     History of Changes
Other Study ID Numbers: CCCWFU 97511, NCI-2012-00164
Study First Received: March 9, 2012
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014