Clinical trial NCT00065195: REST: Reducing End-of-Life Symptoms With Touch
Official title: Efficacy of Massage at the End of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms
Pain
Keywords: Massage
Palliative Care
Hospices
Cancer
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-07-21
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether massage therapy is effective in reducing pain and distress and improving quality of life among cancer patients at life's end.

Detailed description: Relieving physical and emotional symptoms is a key component of end-of-life care. Despite care, terminally ill patients are still significantly burdened by unrelieved symptoms. Therapies that have potential to alleviate these symptoms deserve thorough investigation.

This study will last 3 weeks. Participants in this study will be randomly assigned to receive six sessions of either moving or nonmoving touch therapy, in addition to usual hospice care, for 2 weeks. Moving touch therapy consists of massage therapy in which a trained therapist continually touches a person's body. The nonmoving touch therapy will be conducted by volunteers who have no previous experience in massage. Participants in this group will have a volunteer rub specific body parts for 3-minute intervals. Because current evidence suggests that thoughts of healing may influence the effectiveness of touch therapy, volunteers in the nonmoving therapy group will distract their minds to avoid thinking of healing processes. In both groups, the person administering the touch therapy will note all interruptions during a session, including talk, music, and television. Interviews about medication use, pain, and quality of life will be used to assess participants; these interviews will be conducted at study start, immediately before and after each therapy session, and at Weeks 1, 2, and 3.

Eligibility criteria: Inclusion Criteria:

* Advanced cancer, with at least moderate pain 1 week prior to study entry
* Life expectancy of at least 3 weeks
* Able to speak English

Exclusion Criteria:

* Massage therapy within 1 month prior to study entry
* Current use of anticoagulants
* Platelet count less than 10,000
* Unstable spine that would interfere with touch therapy

Primary outcomes:
measure: Decreased pain
Secondary outcomes:
measure: Less total analgesic medication use.
measure: Improved quality of life
measure: Decreased physical symptom distress
measure: Decreased emotional symptom distress
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Hospice
state: California
city: Colorado Springs
country: United States
facility: Pike's Peak Hospice and Palliative Care
state: Colorado
city: Denver
country: United States
facility: Pathways at Hospice of Metro Denver
state: Colorado
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Lakewood
country: United States
facility: Hospice of St. John
state: Colorado
city: Fort Myers
country: United States
facility: Hope Hospice and Palliative Care
state: Florida
city: Tampa
country: United States
facility: LifePath Hospice and Palliative Care, Inc.
state: Florida
city: Pittsfield
country: United States
facility: Hospice Care in the Berkshires, Inc.
state: Massachusetts
city: Charlotte
country: United States
facility: Hospice at Charlotte
state: North Carolina
Study officials:
affiliation: University of Colorado, Denver
name: Jean S. Kutner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Marlaine Smith, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: