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Recruiting NCT07447700

A Pilot Study to Evaluate the Effectiveness of Focused Massage on Pain, Mobility, and Quality of Life During Radiation Treatment for Patients With Breast Cancer

No phase Interventional Breast Cancer Radiation Therapy Patient

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: upper body massage.
Who it may be relevant to
Registry conditions: Breast Cancer, Radiation Therapy Patient. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this interventional study is to to evaluate the effectiveness and acceptability of a focused upper body massage when offered after radiation treatments to participants diagnosed with breast cancer. Given the prevalence of musculoskeletal complaints during radiation therapy delivery and acknowledging the emotional stress associated with breast cancer diagnosis and treatment, the aims of this pilot study are to: 1) evaluate the effectiveness of a focused upper body massage, available after radiation treatments, on patient's muscle and joint achiness and disability/symptoms of the upper extremities; 2) evaluate the effectiveness of a focused chair massage, available after radiation treatments on health-related quality of life; 3) assess the need for repeating the pre-radiation simulation process and revising the established treatment plan; and 4) and evaluate patient acceptability of the massages offered during the course of radiation treatment.

Interventions

  • Other upper body massage
    brief massage of the upper back, neck, shoulders, arms, and hands; participant is fully clothed during the massage

Primary outcome measures

  • Musculoskeletal and Joint Pain [Time frame: Measured: Baseline; Every 7 days up to 10 weeks; 6 weeks after participant study completion]
  • Disability of the Arm, Shoulder and Hand - short version (QuickDASH) [Time frame: Measured: Baseline; Every 7 days up to 10 weeks; 6 weeks after participant study completion]
Secondary outcome measures (2)
  • Health-related Quality of Life Short Form (SF-12v2) [Time frame: Measured: Baseline; 6 weeks after participant study completion]
  • Acceptability of the Massage (AIM) [Time frame: Measured: 6 weeks after participant study completion]

Eligibility criteria

Inclusion criteria

  • 18 years of age or older
  • Diagnosis of breast cancer
  • Treatment plan for curative intent radiation at SSBC
  • Radiation treatment frequency can be daily, every other day, and twice weekly
  • Agreeable to and available for focused chair massages post-radiation treatments during the prescribed treatment period

Exclusion criteria

  • Patients with recurrent disease (breast cancer)
  • Patients treated palliatively with radiation treatments
  • Inability to read and/or understand English (consent and questionnaires in English)
  • Patients with documented cognitive disorder that limits the ability to independently read, understand, and/or complete the survey measures; i.e. dementia, Alzheimer's
  • Patients with major psychiatric disorders not controlled by medication or other psychiatric treatments

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • The Ohio State University — Columbus

Identifiers

NCT: NCT07447700 · 20251037

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗