CancerNCT04916223
Study to Determine Therapeutic Massage Dosing to Improve Quality of Life in Hospitalized Patients Receiving Palliative Care
A study testing Therapeutic massage in people with Cancer and Heart Failure, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Heart Failure, COPD
- What is being tested?
- Therapeutic massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 26 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 and older
- hospitalized, receiving inpatient palliative care consultation for any indication
Who cannot join
- unable to complete surveys in English
- on negative-pressure isolation
- unstable spine
- platelets < 10,000
- received massage in last 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read the 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.
- Conditions
- Cancer, Heart Failure, COPD, Sepsis, HIV Infections, ESRD
- Being tested
- Therapeutic massage
- Medical subject headings
- Neoplasms, Heart Failure, Pulmonary Disease, Chronic Obstructive, Sepsis, HIV Infections, Kidney Failure, Chronic, Wounds and Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic massageOther
The massage therapists were scheduled on a rotating schedule with two alternates scheduled for each day to ensure adherence to assigned study arm and to avoid "therapist effect" as much as possible. For each enrolled subject, the therapist assessed the subject and created a treatment plan depending on his/her individual needs and preferences. For example, if a subject reported bothersome lower extremity pain, the therapist might focus the massage on that lower extremity or might avoid massaging that lower extremity, depending solely on the preference of the subject. Massage duration was determined by the assigned study arm.
| Study group | Role | What they receive |
|---|---|---|
| 3 x 10-minute massage | Experimental | Subject receives a 10-minute massage daily for three consecutive days Receives: Other: Therapeutic massage |
| 3 x 20-minute massage | Experimental | Subject receives a 20-minute massage daily for three consecutive days Receives: Other: Therapeutic massage |
| Single 20-minute massage | Active comparator | Subject receives one 20-minute massage Receives: Other: Therapeutic massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to post-intervention in McGill Quality of Life Questionnaire Single Item
The McGill QOL Questionnaire is a validated reliable tool to evaluate self-reported QOL. One item in the Questionnaire has been shown to effectively assess subject's self-reported QOL.
Measured: Baseline and one day post intervention
Secondary outcomes (4)
Change from baseline to post-intervention in Edmonton Symptom Assessment Scale
The Edmonton Symptom Assessment Scale is a validated, reliable instrument developed to measure 9 different common symptoms in advanced illness
Measured: Baseline and one day post intervention
Change from baseline to post-intervention in National Comprehensive Cancer Network Distress Thermometer
The NCCN Distress Thermometer is an 11-point Likert scale tool to self-report general distress between 0 (no distress) and 10 (extreme distress)
Measured: Baseline and one day post intervention
Change from baseline to post-intervention in Peace Questionnaire
We adapted a single-item probe of spiritual concerns ("are you at peace?") to a 5-point Likert scale to self-report experience of being at peace, where 0=experiencing no peace and 5=experiencing total peace.
Measured: Baseline and one day post intervention
Satisfaction with assigned intervention
We developed a post-intervention Patient Satisfaction Survey that included pain-related questions from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, modified to reference the current hospitalization
Measured: One day post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Nov 2017
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916223
- Sponsor's protocol ID
- 2017-260
- Status last verified
- Dec 2022
- First submitted
- 1 Jun 2021
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine Therapeutic Massage Dosing to Improve Quality of Life in Hospitalized Patients Receiving Palliative Care
- ClinicalTrials.gov ID
- NCT04916223
- Acronym / sponsor ID
- 2017-260
- Conditions
- Cancer, Heart Failure, COPD, Sepsis, HIV Infections, ESRD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 x 10-minute massage | Experimental | Other: Therapeutic massageSubject receives a 10-minute massage daily for three consecutive days |
| 3 x 20-minute massage | Experimental | Other: Therapeutic massageSubject receives a 20-minute massage daily for three consecutive days |
| Single 20-minute massage | Active comparator | Other: Therapeutic massageSubject receives one 20-minute massage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 and older
- hospitalized, receiving inpatient palliative care consultation for any indication
Key exclusion criteria (5 listed)
- unable to complete surveys in English
- on negative-pressure isolation
- unstable spine
- platelets < 10,000
- received massage in last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic massageThe massage therapists were scheduled on a rotating schedule with two alternates scheduled for each day to ensure adherence to assigned study arm and to avoid "therapist effect" as much as possible. For each enrolled subject, the therapist assessed the subject and created a treatment plan depending on his/her individual needs and preferences. For example, if a subject reported bothersome lower extremity pain, the therapist might focus the massage on that lower extremity or might avoid massaging that lower extremity, depending solely on the preference of the subject. Massage duration was determined by the assigned study arm. | Other | 3 x 10-minute massage, 3 x 20-minute massage, Single 20-minute massage |
Primary outcome
Change from baseline to post-intervention in McGill Quality of Life Questionnaire Single Item
Time frame: Baseline and one day post intervention
The McGill QOL Questionnaire is a validated reliable tool to evaluate self-reported QOL. One item in the Questionnaire has been shown to effectively assess subject's self-reported QOL.
4 secondary outcomes
Change from baseline to post-intervention in Edmonton Symptom Assessment Scale
Time frame: Baseline and one day post intervention
Change from baseline to post-intervention in National Comprehensive Cancer Network Distress Thermometer
Time frame: Baseline and one day post intervention
Change from baseline to post-intervention in Peace Questionnaire
Time frame: Baseline and one day post intervention
Satisfaction with assigned intervention
Time frame: One day post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic massage in people with Cancer and Heart Failure, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to post-intervention in McGill Quality of Life Questionnaire Single Item (time frame: Baseline and one day post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.