NCT01553578

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

March 9, 2012

Last Update Submit

July 2, 2018

Conditions

Anxiety DisorderFatigueMalignant NeoplasmNausea and VomitingPain

Outcome Measures

Primary Outcomes (4)

  • Change scores for each patient on pain scale

    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.

    Approximately 6 months

  • Change scores for each patient on fatigue scale

    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.

    Approximately 6 months

  • Change scores for each patient on nausea scale

    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.

    Approximately 6 months

  • Change scores for each patient on anxiety scale

    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.

    Approximately 6 months

Study Arms (3)

Arm A (healing touch therapy)

EXPERIMENTAL

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

Other: questionnaire administrationProcedure: therapeutic touchBehavioral: management of therapy complications

Arm B (guided imagery)

EXPERIMENTAL

Patients listen to guided imagery audiotapes for 30 minutes.

Other: questionnaire administrationBehavioral: management of therapy complications

Arm C (standard care)

ACTIVE COMPARATOR

Patients receive standard of care.

Other: questionnaire administrationProcedure: standard follow-up care

Interventions

questionnaire administrationOTHER

Ancillary studies

Arm A (healing touch therapy)Arm B (guided imagery)Arm C (standard care)
therapeutic touchPROCEDURE

Receive healing touch therapy

Also known as: healing touch
Arm A (healing touch therapy)
management of therapy complicationsBEHAVIORAL

Receive healing touch therapy

Also known as: complications of therapy, management of
Arm A (healing touch therapy)
standard follow-up carePROCEDURE

Receive standard care

Arm C (standard care)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anxiety DisordersFatigueNeoplasmsNauseaVomitingPain

Interventions

Therapeutic TouchTouch

Condition Hierarchy (Ancestors)

Mental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lisa Hodges

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 14, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

July 5, 2018

Record last verified: 2018-07

Locations

US(1)