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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-06187 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24302 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial tests how well different types of massage therapy works to reduce anxiety during chemotherapy infusions in patients with cancer. Many cancer patients experience moderate to severe anxiety and anxiety can worsen by the anticipation of medical procedures that patients have to receive, particularly chemotherapy. Massage therapy, as a complementary treatment, has shown promise in lessening both physical and psychological symptoms associated with cancer and its treatments. Research has also shown the benefits of massage therapy in reducing pain, stress, anxiety, nausea (upset stomach), fatigue (tiredness), and depression in cancer patients. Different types of massage therapy may potentially reduce some cancer patients' symptoms, enhance their treatment, and reduce treatment related side effects.
PRIMARY OBJECTIVES:
I. To assess the feasibility of 30-minute massages targeting various body regions among patients with cancer receiving anticancer therapy infusion.
II. Assess which type of massage is preferred by patients with cancer receiving anticancer therapy infusion.
SECONDARY OBJECTIVE:
I. To assess the change in anxiety levels after each type of massage therapy during infusion.
EXPLORATORY OBJECTIVE:
I. To evaluate changes in other symptoms, such as: pain, fatigue, nausea, depression, and overall well-being, using data obtained from the Edmonton Symptoms Assessment scale (ESAS) after each type of massage therapy.
OUTLINE:
Patients receive massage therapy according to a randomized schedule to the feet/legs (FL), head/neck/shoulder (HNS), hands/arms (HA), combination of all three groups (FL, HNS, HA) or no massage therapy over 30 minutes for 5 chemotherapy sessions total on study. Patients also undergo saliva sample collection on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (FL, HNS, HA, combination, no massage) | Experimental | Patients receive massage therapy according to a randomized schedule to the FL, HNS, hands/arms (HA), combination of all three groups (FL, HNS, HA) or no massage therapy over 30 minutes over 5 chemotherapy sessions total on study. Patients also undergo saliva sample collection on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive no massage therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Participation rate | Will consider the study feasible if >=70% of patients are able to complete the massage intervention at each session. Descriptive summary will be provided (including 95% confidence intervals [CI]). | Up to 1 year |
| Completion rate | Descriptive summary will be provided (including 95% CI). | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety levels (State-Trait Anxiety Inventory) | Will be assessed by the items from the State-Trait Anxiety Inventory. Will use paired t-tests to assess the impact of each massage intervention, by comparing changes in outcome measures from pre to post intervention within each session. Second, will apply mixed effect models to evaluate the main effects of interventions and time points (and their interaction) on the changes in outcome measures, while accounting for the individual differences, session variability, as well as missing data. These analyses will provide estimates and effect sizes to help inform the design of future studies. They are intended to detect a signal rather than test a formal hypothesis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard T Lee | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope at Irvine Lennar | Recruiting | Irvine | California | 92618 | United States |
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| Biospecimen Collection | Procedure | Undergo saliva sample collection |
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| Massage Therapy | Procedure | Receive FL therapy |
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| Massage Therapy | Procedure | Receive HNS therapy |
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| Massage Therapy | Procedure | Receive HA therapy |
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| Massage Therapy | Procedure | Receive combination FL, HNS, and HA therapy |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 1 year |
| Change in anxiety levels (Edmonton Symptom Assessment System) | Will be assessed by the items from the Edmonton Symptom Assessment System. Will use paired t-tests to assess the impact of each massage intervention, by comparing changes in outcome measures from pre to post intervention within each session. Second, will apply mixed effect models to evaluate the main effects of interventions and time points (and their interaction) on the changes in outcome measures, while accounting for the individual differences, session variability, as well as missing data. These analyses will provide estimates and effect sizes to help inform the design of future studies. They are intended to detect a signal rather than test a formal hypothesis. | Up to 1 year |
| Change in anxiety levels salivary amylase) | Will be assessed by the items from the salivary amylase. Will use paired t-tests to assess the impact of each massage intervention, by comparing changes in outcome measures from pre to post intervention within each session. Second, will apply mixed effect models to evaluate the main effects of interventions and time points (and their interaction) on the changes in outcome measures, while accounting for the individual differences, session variability, as well as missing data. These analyses will provide estimates and effect sizes to help inform the design of future studies. They are intended to detect a signal rather than test a formal hypothesis. | Up to 1 year |
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D013048 | Specimen Handling |
| D008405 | Massage |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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