Breast CancerNCT05100914
Evaluation of the Effects of the Couple-based Family Nursing for Women With Breast Cancer
A study testing Couple-based family nursing in people with Breast Cancer and Women, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer, Women, Mastectomy
- What is being tested?
- Couple-based family nursing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Mar 2019to 7 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Breast Cancer, Women, Mastectomy, Breast-Conserving Surgery
- Being tested
- Couple-based family nursing
- Keywords
- breast cancer, women, couple, family nursing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Couple-based family nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder range of motion
The women's shoulder flexion, shoulder abduction, and shoulder external rotation, ranging from 0° to 180°.
Measured: 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.
Measured: 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.
Measured: Change from Baseline Marital Intimacy at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start14 Mar 2019
- Primary completion2 Dec 2019
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Yu-Ting, Lin, National Defense Medical Center, Taiwan
- Investigators
- Li-Chi Chiang, PhD, Study chair, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100914
- Sponsor's protocol ID
- 201900115B0
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data were not approved by IRB.
Publications
Andrzejczak E, Markocka-Maczka K, Lewandowski A. Partner relationships after mastectomy in women not offered breast reconstruction. Psychooncology. 2013 Jul;22(7):1653-7. doi: 10.1002/pon.3197. Epub 2012 Oct 9.
PubMed 23045167Baucom DH, Porter LS, Kirby JS, Gremore TM, Wiesenthal N, Aldridge W, Fredman SJ, Stanton SE, Scott JL, Halford KW, Keefe FJ. A couple-based intervention for female breast cancer. Psychooncology. 2009 Mar;18(3):276-83. doi: 10.1002/pon.1395.
PubMed 18702064Harris SR, Schmitz KH, Campbell KL, McNeely ML. Clinical practice guidelines for breast cancer rehabilitation: syntheses of guideline recommendations and qualitative appraisals. Cancer. 2012 Apr 15;118(8 Suppl):2312-24. doi: 10.1002/cncr.27461.
PubMed 22488705Ho PJ, Gernaat SAM, Hartman M, Verkooijen HM. Health-related quality of life in Asian patients with breast cancer: a systematic review. BMJ Open. 2018 Apr 20;8(4):e020512. doi: 10.1136/bmjopen-2017-020512.
PubMed 29678980Karki A, Simonen R, Malkia E, Selfe J. Postoperative education concerning the use of the upper limb, and exercise and treatment of the upper limb: cross-sectional survey of 105 breast cancer patients. Support Care Cancer. 2004 May;12(5):347-54. doi: 10.1007/s00520-004-0612-7. Epub 2004 Apr 3.
PubMed 15064932Kibar S, Dalyan Aras M, Unsal Delialioglu S. The risk factors and prevalence of upper extremity impairments and an analysis of effects of lymphoedema and other impairments on the quality of life of breast cancer patients. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12433. Epub 2016 Jan 13.
PubMed 26764197Levy EW, Pfalzer LA, Danoff J, Springer BA, McGarvey C, Shieh CY, Morehead-Gee A, Gerber LH, Stout NL. Predictors of functional shoulder recovery at 1 and 12 months after breast cancer surgery. Breast Cancer Res Treat. 2012 Jul;134(1):315-24. doi: 10.1007/s10549-012-2061-1. Epub 2012 Apr 19.
PubMed 22527107Li M, Chan CWH, Chow KM, Xiao J, Choi KC. A systematic review and meta-analysis of couple-based intervention on sexuality and the quality of life of cancer patients and their partners. Support Care Cancer. 2020 Apr;28(4):1607-1630. doi: 10.1007/s00520-019-05215-z. Epub 2019 Dec 24.
PubMed 31872299Li Q, Loke AY. A systematic review of spousal couple-based intervention studies for couples coping with cancer: direction for the development of interventions. Psychooncology. 2014 Jul;23(7):731-9. doi: 10.1002/pon.3535. Epub 2014 Apr 10.
PubMed 24723336Lopes VB, Lobo APA, Da Silva Junior GB, Melo AK, Lamboglia CG, Silva CABD. The experience of male spouses in the context of breast cancer: a systematic review of the literature. Psychol Health Med. 2018 Jan;23(1):89-98. doi: 10.1080/13548506.2017.1332374. Epub 2017 May 27.
PubMed 28552007Lovelace DL, McDaniel LR, Golden D. Long-Term Effects of Breast Cancer Surgery, Treatment, and Survivor Care. J Midwifery Womens Health. 2019 Nov;64(6):713-724. doi: 10.1111/jmwh.13012. Epub 2019 Jul 19.
PubMed 31322834Meleis AI, Sawyer LM, Im EO, Hilfinger Messias DK, Schumacher K. Experiencing transitions: an emerging middle-range theory. ANS Adv Nurs Sci. 2000 Sep;23(1):12-28. doi: 10.1097/00012272-200009000-00006.
PubMed 10970036McNeely ML, Binkley JM, Pusic AL, Campbell KL, Gabram S, Soballe PW. A prospective model of care for breast cancer rehabilitation: postoperative and postreconstructive issues. Cancer. 2012 Apr 15;118(8 Suppl):2226-36. doi: 10.1002/cncr.27468.
PubMed 22488697Ribeiro IL, Moreira RFC, Ferrari AV, Alburquerque-Sendin F, Camargo PR, Salvini TF. Effectiveness of early rehabilitation on range of motion, muscle strength and arm function after breast cancer surgery: a systematic review of randomized controlled trials. Clin Rehabil. 2019 Dec;33(12):1876-1886. doi: 10.1177/0269215519873026. Epub 2019 Sep 3.
PubMed 31480855Sharma A, Saneha C, Phligbua W. Effects of Dyadic Interventions on Quality of Life among Cancer Patients: An Integrative Review. Asia Pac J Oncol Nurs. 2021 Jan 29;8(2):115-131. doi: 10.4103/apjon.apjon_63_20. eCollection 2021 Mar-Apr.
PubMed 33688560
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05100914
- Acronym / sponsor ID
- 201900115B0
- Conditions
- Breast Cancer, Women, Mastectomy, Breast-Conserving Surgery
- Keywords
- breast cancer, women, couple, family nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Couple-based family nursing | Experimental | Other: Couple-based family nursingWomen 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. |
| Treatment as usual | Active comparator | Other: Couple-based family nursingAll 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couple-based family nursingSpouses 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. | Other | Couple-based family nursing, Treatment as usual |
Primary outcome
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°.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Background: PubMed 23045167Andrzejczak E, Markocka-Maczka K, Lewandowski A. Partner relationships after mastectomy in women not offered breast reconstruction. Psychooncology. 2013 Jul;22(7):1653-7. doi: 10.1002/pon.3197. Epub 2012 Oct 9.
- Background: PubMed 18702064Baucom DH, Porter LS, Kirby JS, Gremore TM, Wiesenthal N, Aldridge W, Fredman SJ, Stanton SE, Scott JL, Halford KW, Keefe FJ. A couple-based intervention for female breast cancer. Psychooncology. 2009 Mar;18(3):276-83. doi: 10.1002/pon.1395.
- Background: PubMed 22488705Harris SR, Schmitz KH, Campbell KL, McNeely ML. Clinical practice guidelines for breast cancer rehabilitation: syntheses of guideline recommendations and qualitative appraisals. Cancer. 2012 Apr 15;118(8 Suppl):2312-24. doi: 10.1002/cncr.27461.
- Background: PubMed 29678980Ho PJ, Gernaat SAM, Hartman M, Verkooijen HM. Health-related quality of life in Asian patients with breast cancer: a systematic review. BMJ Open. 2018 Apr 20;8(4):e020512. doi: 10.1136/bmjopen-2017-020512.
- Background: PubMed 15064932Karki A, Simonen R, Malkia E, Selfe J. Postoperative education concerning the use of the upper limb, and exercise and treatment of the upper limb: cross-sectional survey of 105 breast cancer patients. Support Care Cancer. 2004 May;12(5):347-54. doi: 10.1007/s00520-004-0612-7. Epub 2004 Apr 3.
- Background: PubMed 26764197Kibar S, Dalyan Aras M, Unsal Delialioglu S. The risk factors and prevalence of upper extremity impairments and an analysis of effects of lymphoedema and other impairments on the quality of life of breast cancer patients. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12433. Epub 2016 Jan 13.
- Background: PubMed 22527107Levy EW, Pfalzer LA, Danoff J, Springer BA, McGarvey C, Shieh CY, Morehead-Gee A, Gerber LH, Stout NL. Predictors of functional shoulder recovery at 1 and 12 months after breast cancer surgery. Breast Cancer Res Treat. 2012 Jul;134(1):315-24. doi: 10.1007/s10549-012-2061-1. Epub 2012 Apr 19.
- Background: PubMed 31872299Li M, Chan CWH, Chow KM, Xiao J, Choi KC. A systematic review and meta-analysis of couple-based intervention on sexuality and the quality of life of cancer patients and their partners. Support Care Cancer. 2020 Apr;28(4):1607-1630. doi: 10.1007/s00520-019-05215-z. Epub 2019 Dec 24.
- Background: PubMed 24723336Li Q, Loke AY. A systematic review of spousal couple-based intervention studies for couples coping with cancer: direction for the development of interventions. Psychooncology. 2014 Jul;23(7):731-9. doi: 10.1002/pon.3535. Epub 2014 Apr 10.
- Background: PubMed 28552007Lopes VB, Lobo APA, Da Silva Junior GB, Melo AK, Lamboglia CG, Silva CABD. The experience of male spouses in the context of breast cancer: a systematic review of the literature. Psychol Health Med. 2018 Jan;23(1):89-98. doi: 10.1080/13548506.2017.1332374. Epub 2017 May 27.
- Background: PubMed 31322834Lovelace DL, McDaniel LR, Golden D. Long-Term Effects of Breast Cancer Surgery, Treatment, and Survivor Care. J Midwifery Womens Health. 2019 Nov;64(6):713-724. doi: 10.1111/jmwh.13012. Epub 2019 Jul 19.
- Background: PubMed 10970036Meleis AI, Sawyer LM, Im EO, Hilfinger Messias DK, Schumacher K. Experiencing transitions: an emerging middle-range theory. ANS Adv Nurs Sci. 2000 Sep;23(1):12-28. doi: 10.1097/00012272-200009000-00006.
- Individual participant dataSharing planned: No. Individual participant data were not approved by IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Chi Chiang, PhD study chair
National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couple-based family nursing in people with Breast Cancer and Women, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder range of motion (time frame: Change from Baseline Shoulder Range of Motion at one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05100914, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.