Breast Cancer, Radiation Therapy Patient
Conditions
Keywords
breast cancer, radiation therapy, muscle and joint achiness, quality of life, re-simulation
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.
Interventions
OTHERupper body massage
brief massage of the upper back, neck, shoulders, arms, and hands; participant is fully clothed during the massage
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Musculoskeletal and Joint Pain | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life Short Form (SF-12v2) | 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). |
| Acceptability of the Massage (AIM) | 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. |
Countries
United States
Contacts
CONTACTBeth Steinberg, PhD, RN
CONTACTSienna Andres, BA
PRINCIPAL_INVESTIGATORBeth Steinber, PhD, RN
Ohio State University
PRINCIPAL_INVESTIGATORSachin Jhawar, MD
Ohio State University
Outcome results
None listed