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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Radiation Therapy Patient
• Intervention / Treatment: Other: upper body massage

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth Steinberg, PhD, RN; Phone Number: 614-406-7067; Email: beth.steinberg@osumc.edu
• Study Contact Backup: Name: Sienna Andres, BA; Phone Number: 380-283-6479; Email: sienna.andres@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Beth Steinberg, PhD, RN; Phone Number: 614-406-7067; Email: beth.steinberg@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years of age or older
2. Diagnosis of breast cancer
3. Treatment plan for curative intent radiation at SSBC
4. Radiation treatment frequency can be daily, every other day, and twice weekly
5. Agreeable to and available for focused chair massages post-radiation treatments during the prescribed treatment period

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Other: upper body massage; brief massage of the upper back, neck, shoulders, arms, and hands; participant is fully clothed during the massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Musculoskeletal and Joint Pain	National Cancer Institute (NCI) Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) Custom Survey: self-reported musculoskeletal and joint pain defined by achiness over the last 7 days. Questions 1a, 1b, 1c--frequency, severity, and interference with usual activities d/t muscle achiness. Responses 1a, "not at all", "a little bit", "somewhat", "quite a bit", "very much"; 1b, "none", "mild", "moderate", "severe", and "very severe"; 1c,"not at all", "a little bit", "somewhat", "quite a bit", and "very much". Questions 2a, 2b, 2c-frequency, severity, and interference with usual activities d/t "aching joints". Responses 2a, "never", "rarely", "occasionally", "frequently", "almost constantly"; 2b, "none", "mild", "moderate", "severe", and "very severe", 2c,"not at all", "a little bit", "somewhat", "quite a bit", and "very much".	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)	An 11-item scale r/t symptoms/ability to perform upper extremity (hand, arm, shoulder) activities during the past 7 days. Q1-6 focus on activities; responses: 1 (no difficulty), 2 (mild difficulty), 3 (moderate difficulty), 4 (severe difficulty), 5 (unable). Q7-asks to what extent has arm, shoulder, hand problems interfered with social activities. Responses: 1 (not at all), 2 (slightly), 3 (moderately), 4 (quite a bit), 5 (extremely). Q8-limitations in work/other regular daily activities due to arm, shoulder, or hand problems. Responses: 1 (not limited at all), 2 (slightly limited), 3 (moderately limited), 4 (very limited), 5 (unable). Q9 and 10-rate severity of arm, shoulder, or hand pain and tingling in the arm, shoulder or hand. Responses: 1 (none), 2 (mild), 3 (moderate), 4 (severe), 5 (extreme). Q11-difficulty with sleeping because of arm, shoulder, hand pain. Responses: 1 (no difficulty), 2 (mild difficulty), 3 (moderate difficulty), 4 (severe difficulty), 5 (sleep disruption).	Measured: Baseline; Every 7 days up to 10 weeks; 6 weeks after participant study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of Life Short Form (SF-12v2)	A 12-item self-report instrument used to measure health-related quality of life. Questions grouped into 8 different health domains including physical functioning, role physical, bodily pain, general health, vitality, social function, role emotional, and mental health. Respondents rate their perception of health, how their physical and/or emotional health limits moderate activity, work or other regular activities inside and outside of the home, and social activities. All responses are answered with Likert scale choices of 1 (all of the time), 2 (most of the time), 3 (some of the time), 4 (a little of the time), and 5 (none of the time).	Measured: Baseline; 6 weeks after participant study completion
Acceptability of the Massage (AIM)	To evaluate patient acceptability of the massages offered during the course of radiation treatments using the AIM, Acceptability of the Intervention Measure (Weiner et al., 2017). A 4-item self-report measure, acceptability of the massage intervention by patients in this study will be offer important for a future investigation (In, 2017). Questions include: 1. The upper body massages met my approval.; 2. The upper body massages were appealing to me.; 3. I liked the upper body massages.; and 4. I welcomed the upper body massages. Responses include; 1-completely disagree; 2-disagree; 3-neither agree nor disagree; 4-agree; 5-completely agree.	Measured: 6 weeks after participant study completion

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Beth Steinber, PhD, RN, Ohio State University; Principal Investigator: Sachin Jhawar, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; quality of life; radiation therapy; muscle and joint achiness; re-simulation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 20251037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Continue to investigate appropriate and secure data repository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No