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NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Beth Steinberg, PhD, RN

CONTACT

[email protected]

614-406-7067

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

upper body massage

Other

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

Primary outcomes

  1. Musculoskeletal and Joint Pain

    Time frame: Measured: Baseline; Every 7 days up to 10 weeks; 6 weeks after participant study completion

    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".

  2. 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

    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).

Secondary outcomes

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

    Time frame: Measured: Baseline; 6 weeks after participant study completion

    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).

  2. Acceptability of the Massage (AIM)

    Time frame: Measured: 6 weeks after participant study completion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Steinberg, PhD, RN

CONTACT

[email protected]

614-406-7067

Sienna Andres, BA

CONTACT

[email protected]

380-283-6479

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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