Clinical trial NCT04916223: Study to Determine Therapeutic Massage Dosing to Improve Quality of Life in Hospitalized Patients Receiving Palliative Care
Official title: Study to Determine Therapeutic Massage Dosing to Improve Quality of Life in Hospitalized Patients Receiving Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Heart Failure
COPD
Sepsis
HIV Infections
ESRD
Trauma
Stroke
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Therapeutic massage is the most common non-traditional treatment option offered to improve quality of life, provide comfort and decrease pain in hospice and palliative care settings outside the hospital. Three systematic reviews of data in general pain, surgical and cancer populations found massage to be effective for treating pain versus active comparators.

Given the remarkable negative impact on QOL experienced by patients hospitalized with a serious progressive illness, a nationwide opioid crisis in the setting of public concern for untreated pain, and patient demand for integrative therapies, we wish to investigate non-traditional methods of supporting patients in pain and providing clinicians with viable alternatives. Unfortunately, very little is known about optimal delivery of massage interventions in the hospital setting, including dosing parameters such as time and frequency

We conducted a single center comparative effectiveness study to evaluate therapeutic massage "dosing" to improve self-reported quality-of-life in hospitalized patients receiving palliative care consultation.

Detailed description: Palliative care (PC) provides expert symptom management and communication skills for patients and families facing serious life-limiting illness in the hospital. Many such patients experience lower quality of life (QOL) due to moderate-severe pain or other symptoms and require strong pharmacotherapies - often controlled substances such as opioids or benzodiazepines - to alleviate associated distress. A major tenet of quality supportive care is the combination of many types of therapy, both pharmacologic and nonpharmacologic. Patients with serious life-limiting illnesses often rely on the use of nonpharmacologic therapies to manage pain or other symptoms at home. However, implementing complementary therapies in the hospital setting can be challenging and thus they are rarely available for hospitalized patients with serious illness. Patients often request non-drug options, but medications remain the mainstay of treating pain while hospitalized.

Therapeutic massage is the most common non-traditional treatment option offered to improve quality of life, provide comfort and decrease pain in hospice and palliative care settings outside the hospital. Nevertheless, there remains limited data describing the impact of therapeutic massage in hospitalized patients receiving palliative care.

Additionally, in the hospital setting, the logistical challenges of providing massage therapy include a number of setting-specific factors. A massage therapy session may be interrupted by care being provided by other members of the team, by personal visitors, or by the activities of his/her roommate in a semi-private room. Also, the availability of massage therapy may be such that a patient's session time is limited because of the high demand on the short amount of time a non-integrated, contracted massage therapist has to see multiple patients. Given the remarkable negative impact on QOL experienced by patients hospitalized with a serious progressive illness, a nationwide opioid crisis in the setting of public concern for untreated pain, and patient demand for integrative therapies, we wish to investigate non-traditional methods of supporting patients in pain and providing clinicians with viable alternatives. Unfortunately, very little is known about optimal delivery of massage interventions in the hospital setting, including dosing parameters such as time and frequency.

The purpose of this study is to examine the impact of different massage dosing strategies on QOL, symptom management, and satisfaction in hospitalized patients already receiving PC consultation.

Eligibility criteria: Inclusion Criteria:

* age 18 and older
* hospitalized, receiving inpatient palliative care consultation for any indication

Exclusion Criteria:

* unable to complete surveys in English
* on negative-pressure isolation
* unstable spine
* platelets \< 10,000
* received massage in last 30 days

Primary outcomes:
measure: Change from baseline to post-intervention in McGill Quality of Life Questionnaire Single Item
timeFrame: Baseline and one day post intervention
Secondary outcomes:
measure: Change from baseline to post-intervention in Edmonton Symptom Assessment Scale
timeFrame: Baseline and one day post intervention
measure: Change from baseline to post-intervention in National Comprehensive Cancer Network Distress Thermometer
timeFrame: Baseline and one day post intervention
measure: Change from baseline to post-intervention in Peace Questionnaire
timeFrame: Baseline and one day post intervention
measure: Satisfaction with assigned intervention
timeFrame: One day post intervention
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
References: