Breast CancerNCT07447700
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
A study testing upper body massage in people with Breast Cancer and Radiation Therapy Patient, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Radiation Therapy Patient
- What is being tested?
- upper body massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Beth Steinberg, PhD, RN, 614-406-7067, beth.steinberg@osumc.edu
About this study
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
- Being tested
- upper body massage
- Keywords
- breast cancer, radiation therapy, muscle and joint achiness, quality of life, re-simulation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper body massageOther
brief massage of the upper back, neck, shoulders, arms, and hands; participant is fully clothed during the massage
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: upper body massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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)
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: 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: Measured: 6 weeks after participant study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Apr 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Steinberg, Ohio State University Comprehensive Cancer Center
- Investigators
- Beth Steinber, PhD, RN, Principal investigator, Ohio State UniversitySachin Jhawar, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447700
- Sponsor's protocol ID
- 20251037
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Continue to investigate appropriate and secure data repository
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07447700
- Acronym / sponsor ID
- 20251037
- Conditions
- Breast Cancer, Radiation Therapy Patient
- Keywords
- breast cancer, radiation therapy, muscle and joint achiness, quality of life, re-simulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: upper body massage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upper body massagebrief massage of the upper back, neck, shoulders, arms, and hands; participant is fully clothed during the massage | Other | Intervention |
Primary outcome
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".
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).
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided. Continue to investigate appropriate and secure data repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beth Steinber, PhD, RN principal investigator
Ohio State University
Sachin Jhawar, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper body massage in people with Breast Cancer and Radiation Therapy Patient, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth Steinberg, PhD, RN (614-406-7067, beth.steinberg@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal and Joint Pain (time frame: Measured: Baseline; Every 7 days up to 10 weeks; 6 weeks after participant study completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.