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

NCT05100914 | Completed

• 1 other identifier: 201900115B0
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Women; Mastectomy; Breast-Conserving Surgery

Keywords

breast cancer; women; couple; family nursing

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Couple-based family nursing

EXPERIMENTAL

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

Treatment as usual

ACTIVE COMPARATOR

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

Interventions

Couple-based family nursing OTHER

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.

Couple-based family nursing; Treatment as usual

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Yu-Ting Lin

Taipei, Neihu, 11490, Taiwan

Location

Related Publications (19)

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  PMID: 28552007 BACKGROUND

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  PMID: 10970036 BACKGROUND

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Li-Chi Chiang, PhD

  National Defense Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The block randomization allocation sequence was computer-generated random numbers with a 1:1 ratio by Microsoft Excel. 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. Given the nature of the interventions, it was not allowed to blind the participates and the research nurse.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The Institute for Patient and Family-Centered Care promotes four core concepts: dignity and respect, information sharing, participation, and collaboration. Health care practitioners listen to and respect patients and families' perspectives and choices as well as incorporate the knowledge, values, beliefs, and cultural backgrounds of patients and families into the care plan. Affirmative and useful methods are employed for communicating data that are complete, accurate, and unbiased with patients and families, so that they receive data expediently, participate effectively, and make decisions in care. Health care practitioners encourage and support the families of patients for participation in caring and making decisions that align with families' preferences. Health care practitioners collaborate with patients and families in program development, implementation, and evaluation.

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 29, 2021
• Study Start: March 14, 2019
• Primary Completion: December 2, 2019
• Study Completion: January 7, 2020
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)