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

NCT07447700 | Recruiting DMC

• 1 other identifier: 20251037
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Radiation Therapy Patient

Keywords

breast cancer; radiation therapy; muscle and joint achiness; quality of life; re-simulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Health-related Quality of Life Short Form (SF-12v2)

  Measured: Baseline; 6 weeks after participant study completion

• Acceptability of the Massage (AIM)

  Measured: 6 weeks after participant study completion

Study Arms (1)

Intervention

EXPERIMENTAL

Other: upper body massage

Interventions

upper body massage OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Beth Steinber, PhD, RN

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Sachin Jhawar, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Steinberg, PhD, RN

CONTACT

614-406-7067; beth.steinberg@osumc.edu

Sienna Andres, BA

CONTACT

380-283-6479; sienna.andres@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Research

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: March 3, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-02

Locations

US (1)