Evaluation of the Effects of the Couple-based Family Nursing for Women With Breast Cancer

October 29, 2021 updated by: Yu-Ting, Lin, National Defense Medical Center, Taiwan

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sample size: G*Power software was applied for estimating the sample size. Based on the relevant study "A couple-based intervention for female breast cancer" (Baucom et al., 2009), the median interpolated effect size across all female measures at posttest was 0.61. The type I error α was set at 0.05, statistical power was set at 0.8, and the effect size was set at 0.61 by using the independent sample t-test. We estimated a total sample number of 68, comprising the sample size of 34 for the experimental group and the sample size of 34 for the control group.

Method: The women with breast cancer and their spouses as couples were randomly allocated to the treatment as usual groups or couple-based family nursing groups in a 1:1 ratio by using computer-generated randomization. All eligible participants were recruited by a research assistant from the surgical wards. Participants were randomly allocated using sequentially numbered sealed envelopes. The envelopes were opened just before the operation, the research nurse who was involved in the data collection was blinded to the group allocation, and participants were not informed of their group allocation status. All participants were given a letter that contained the details of the research and informed the patients and spouses that they had the right to abstain from the research at any time, for any reason, and that participation and lack thereof would not affect their rights to treatment and care. Each participant was informed about the research and provided their written informed consent.

Couple-based family nursing: Besides the standard care and teaching program, the nurse researcher who has well trained about the breast cancer care family nursing and couple interviewing techniques. provided the women and their spouses a 30-60 minutes couple of interviews after the standard teaching program. The detail of the couple interview was followed the core concept of the Institute for Patient and Family-Centered Care (IPFCC, 2021), dignity and respect, information sharing, participation, and collaboration. The necessary caring knowledge was provided, the important value of couple together, and caring role to help their spouses to coach and help their wives to perform the rehabilitation during the critical hospitalization stage until to discharge back to home. In this intervention stage, the research nurse empowered their spouses to assist women with daily couple-based rehabilitation with a specific workbook that contained uncomplicated illustrations demonstrating what to expect during the first 48 hours after breast surgery. Firstly, we listened to couples' perspectives and assessed couples' knowledge and skills regarding arm rehabilitation; subsequently, we could understand spouses' willingness and values regarding assistance. Secondly, we provided comprehensive and unbiased data and clarified misinformation regarding arm rehabilitation. We taught couples 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 were required to support patients' wrist and elbow joints and maintain the arm 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. Thirdly, we investigated the concerns related to couples' practice rehabilitation movements. We explained to couples the distinctions between rehabilitation with and without spousal assistance to encourage couples to participate in this care program. Finally, we collaborated with each couple to develop an individualized rehabilitation program.

Data analysis: All data were analyzed using SPSS software version 24.0 and following intention-to-treat principles. Descriptive statistics of demographic and clinical characteristics were evaluated using chi-square tests for categorical variables. The outcome measures were analyzed at baseline and the group × time interaction effect between the two groups at one-month post-surgery by using a generalized estimating equation. The demographic and clinical characteristics were presented as numbers and percentages (%), the outcome measures were presented as means and standard deviations for participants. The level of significance was set at p < 0.05, and the intervention effects were considered to be significant at p ≤ 0.05.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Neihu
      • Taipei, Neihu, Taiwan, 11490
        • Yu-Ting Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Couple-based family nursing
Women and their spouses were provided couple-based family nursing based on dignity and respect, information sharing, participation and collaboration for 30-60 minutes with couple-based interviews for arm rehabilitation. 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.
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.
ACTIVE_COMPARATOR: Treatment as usual
All women in the control group received hospital standard operative care, and couples attended a routine, 30-60-minute presentation about rehabilitation after breast surgery without any specific couple-based dyad interview.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder range of motion
Time Frame: Change from Baseline Shoulder Range of Motion at one month
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
Functional Assessment of Cancer Therapy-Breast
Time Frame: Change from Baseline Quality of Life at one months
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
Marital intimacy inventory
Time Frame: Change from Baseline Marital Intimacy at one month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Defense Medical Center, Taiwan

Collaborators

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Li-Chi Chiang, PhD, National defense medical center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 14, 2019

Primary Completion (ACTUAL)

December 2, 2019

Study Completion (ACTUAL)

January 7, 2020

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (ACTUAL)

October 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201900115B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data were not approved by IRB.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Couple-based family nursing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe