CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Couple-based family nursingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05100914
NCT05100914N/ACompleted

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.

National Defense Medical Center, Taiwan·interventional·Posted Oct 29, 2021·Updated Nov 8, 2021

In Brief

A clinical study evaluating Couple-based family nursing for Breast Cancer and 3 related conditions. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 29, 2021
Enrollment StartMar 14, 2019
Primary CompletionDec 2, 2019
Study CompletionJan 7, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.7 years ago

Interventions

Couple-based family nursingother

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.