Health TrialsbyHealthPanel

Different Types of Massage Therapy to Reduce Anxiety During Chemotherapy Infusion in Patients With Cancer

ConditionsHematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must be 18 years of age or older at time of consent

The study is open to all participants regardless of gender, race, or ethnicity

Participants should have had at least 1 cycle of the chemotherapy regimen at the time of recruitment

Participant must have a baseline anxiety score > 3 on the Visual Analog scale (VAS)

Disqualifiers

Platelet count less than 20,000. Patients taking anticoagulants are not excluded, as the protocol for massage in infusion ensures that deep pressure massage is never performed, and patient's massage will not exceed a 3 on the Walton scale

Absolute neutrophil count (ANC) less than 500

Patient has received radiation therapy to any of the targeted areas within the past 90 days

Any patient that is currently using a cold therapy device that would interfere with their ability to have a massage without removing the device (cold gloves, cold socks)

Trial design

Design model

Single group

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive no massage therapy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo saliva sample collection

  • Massage Therapy

    Procedure/Surgery

    Receive FL therapy

  • Massage Therapy

    Procedure/Surgery

    Receive HNS therapy

  • Massage Therapy

    Procedure/Surgery

    Receive HA therapy

  • Massage Therapy

    Procedure/Surgery

    Receive combination FL, HNS, and HA therapy

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Supportive Care (FL, HNS, HA, combination, no massage)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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 \[CI\]).

Time frame
Up to 1 year
2

Completion rate

Descriptive summary will be provided (including 95% CI).

Time frame
Up to 1 year

Secondary outcomes

1

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.

Time frame
Up to 1 year
2

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.

Time frame
Up to 1 year
3

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.

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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