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Acupressure and Relaxation for Nausea Control

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University of Rochester

Status and phase

Completed
Phase 2
Phase 1

Conditions

Nausea

Treatments

Behavioral: Acupressure expectancy enhancement

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information.

This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients' response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea.

The objectives of this study are as follow:

  1. To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management will result in reduced chemotherapy-induced nausea.
  2. To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management will result in increased health-related quality of life (HRQL) in patients receiving emetogenic chemotherapy.

To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management is more effective than a single-tiered strategy in reducing chemotherapy- induced nausea.

Full description

This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information.

This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients' response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea.

The objectives of this study are as follow:

  1. To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management will result in reduced chemotherapy-induced nausea.
  2. To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management will result in increased health-related quality of life (HRQL) in patients receiving emetogenic chemotherapy.

To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management is more effective than a single-tiered strategy in reducing chemotherapy- induced nausea.

The study contains the following arms:

  1. Control handout and control tape.
  2. Active handout and control tape.
  3. Control handout and active tape.
  4. Active handout and active tape.

Enrollment

83 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Have a diagnosis of breast cancer. 2) Be scheduled to receive a chemotherapy treatment containing doxorubicin (any dose) without concurrent radiotherapy or interferon. (Note: Chemotherapy agents in addition to doxorubicin may be given.) 3) Be 18 years of age or older. 3) Be chemotherapy naïve. 5) Be a female.

Exclusion criteria

  1. Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

83 participants in 4 patient groups

1
Sham Comparator group
Description:
Expectancy neutral handout and expectancy neutral tape
Treatment:
Behavioral: Acupressure expectancy enhancement
2
Experimental group
Description:
Expectancy enhancing handout and expectancy neutral tape
Treatment:
Behavioral: Acupressure expectancy enhancement
3
Experimental group
Description:
Expectancy neutral handout and expectancy enhancing tape
Treatment:
Behavioral: Acupressure expectancy enhancement
4
Experimental group
Description:
Expectancy enhancing handout and expectancy enhancing tape
Treatment:
Behavioral: Acupressure expectancy enhancement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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