Breast Cancer Clinical Trial
Official title:
A Nurse Empowered Spouses to Assist the Women With Breast Cancer Doing Daily Rehabilitation, and Evaluate the Effects on the Shoulder Range of Motion, Quality of Life, and Marital Intimacy.
Verified date | October 2021 |
Source | National Defense Medical Center, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The women with breast cancer and their spouses experienced physical and mental distresses together, nevertheless, the spouses were the significant supporters for patients during post-surgery rehabilitation. Based on the patient and family-centered care (PFCC), it was hypothesized that the couple engages in post-surgery rehabilitation could help women to have an improved shoulder range of movement, quality of life, and couples have better marital intimacy. All the women were eligible to be included in the randomized control trial if diagnosed with breast cancer, received breast surgery, her spouses were accompanying, and gave written consents. Women were randomized into two groups. The control group continues to receive usual care. The experimental group, who received couple-based family nursing (30-60 minutes couple-based interviews) based on the core concepts of PFCC: dignity and respect, information sharing, participation, and collaboration. The study nurse empowered spouses to assist the women's daily rehabilitation with a special workbook by clear pictures demonstration.
Status | Completed |
Enrollment | 70 |
Est. completion date | January 7, 2020 |
Est. primary completion date | December 2, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of stage 0-3 breast cancer made by a specialist physician - Women and spouses with a legal marriage - Women and spouses aged =20 years - Mastectomy or breast-conserving surgery - Women and spouses with no history of mental illness - Spouses who were willing to participate in postoperative care - Women and spouses who could read and write in Chinese. Exclusion Criteria: - Women and spouses without a legal marriage - Diagnosis of terminal breast cancer - Women and spouses aged <20 years - Planned or had undergone breast reconstruction - Active chemotherapy or radiotherapy - Women and spouses with a history of mental illness - Women and spouses currently undergoing psychotherapy. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Yu-Ting Lin | Taipei | Neihu |
Lead Sponsor | Collaborator |
---|---|
National Defense Medical Center, Taiwan | Chang Gung Memorial Hospital |
Taiwan,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Shoulder range of motion | The women's shoulder flexion, shoulder abduction, and shoulder external rotation, ranging from 0° to 180°. | Change from Baseline Shoulder Range of Motion at one month | |
Primary | Functional Assessment of Cancer Therapy-Breast | The quality of life of women with breast cancer, including physical well-being , social and family well-being , emotional well-being , functional well-being , and additional concerns-breast. The total score from 0 to 148, higher scores indicate more favorable quality of life of patients. | Change from Baseline Quality of Life at one months | |
Primary | Marital intimacy inventory | The marital intimacy of couple, including spiritual intimacy , physical intimacy , sexual intimacy , social intimacy , and emotional intimacy. The total scores from 42 to 210, higher scores indicate more favorable marital intimacy. | Change from Baseline Marital Intimacy at one month |
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