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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05100914
Other study ID # 201900115B0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 14, 2019
Est. completion date January 7, 2020

Study information

Verified date October 2021
Source National Defense Medical Center, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Other:
Couple-based family nursing
Spouses were taught the following rehabilitation movements: hand squeeze, wrist, and elbow flexion and extension, pendulum exercise, finger wall-climbing exercise, hair combing, wall pushup, pulley exercise, and turning around exercise. Arm rehabilitation begins within 48 hours postoperatively, and each movement should be incrementally increased in terms of exertion and repetition until the patient reaches 10 repetitions, 2-3 times daily, for one month. Spouses must support patients' wrist and elbow joints and maintain the arms perpendicular to the body. Spouses were instructed that if women experience negative emotions during the rehabilitation movements, spouses can express support to his wife through body language, such as kissing, holding hands, touching, or hugging.

Locations

Country Name City State
Taiwan Yu-Ting Lin Taipei Neihu

Sponsors (2)

Lead Sponsor Collaborator
National Defense Medical Center, Taiwan Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (19)

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Outcome

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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