Effects of Transtheoretical Model-based Intervention on the Self-management of Patients With an Ostomy
NCT ID: NCT03681821
Last Updated: 2018-09-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
94 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-08-01
Study Completion Date
2013-03-31
Brief Summary
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Colorectal cancer (CRC) is one of the most commonly diagnosed cancers worldwide. The main treatment approach is radical surgery, and the auxiliary treatment may be chemotherapy, radiotherapy, immunotherapy and other supportive therapies, which can increase the resection rate, reduce the recurrence rate, and improve the survival rate. Abdominoperineal resection with an ostomy and the formation of a permanent ostomy continue to be the primary and radical surgical approaches for many patients with rectal cancer, which results in the loss of defecation control function.
Although ostomy-related surgery is a life-saving procedure in most cases, it inevitably elicits some complex and lifelong consequences, such as uncontrolled gas and stool emissions, disturbed patients' body images, and effects their social and sexual lives, which place heavy pressure on ostomy self-management.
Some studies have revealed the various ways that patients' lives are affected by their stoma, including changes to their quality of life, body image, and social life, requiring coping and practical adjustments. Others have shown that not enough attention has been paid to patients' self-management abilities, with most care being provided by nurses or caregivers, leaving little opportunities for patients to manage on their own. Consequently, their self-management ability after discharge remains weak, especially their related knowledge and skills. Studies have shown that 33.0-80.4% of patients with an ostomy cannot cope with the problems encountered in ostomy care.
Many scholars focused on the ability of early self-management in patients with an ostomy after discharge, and there were several issues in the field of stoma nursing care, such as insufficient discharge preparedness because of shortened hospital stays and a lack of systematic acquisition of related knowledge and skills. Others highlighted the paucity of attention paid to the post-discharge needs of patients with a stoma and a lack of formal training for follow-up.
Currently, self-management programs for patients with an ostomy mainly focus on the passive problem-solving model led by nurses and less emphasize has been placed on the self-assessment of patients who passively accept relevant knowledge and skills. This is insufficient for the pertinence, continuity, operability, and promotion of self-management. It is essential to call for a patient-tailored and theoretical approach to improve self-management and promote rehabilitation.
The transtheoretical model (TTM) is an empirically validated model of individual behavioral change, which involves progress through a series of stages to make a particular behavioral change. TTM-based interventions have been applied to facilitate health behavioral changes, such as physical exercise, smoking cessation, and weight management, studies of which continue to demonstrate positive effects. There have been few studies of patients with an ostomy using TTM as an interventional tool to provide continuous and dynamic education. Therefore, this study decided to investigate the use of an integrated method of incorporating TTM into patient instruction and to provide assistance to enhance the self-management ability of patients with an ostomy.
The aim of this study was to determine the effects of a transtheoretical model (TTM)-based intervention on ostomy self-management on patients' stages of change, processes of change, decisional balance, and self-efficacy. The study's hypotheses were: (1) There would be no significant difference between the intervention group and the control group before the intervention, and after intervention there would be more patients in the intervention group than those in the control groups. (2) Patients in the intervention group would achieve greater improvement in the ability of self-management than those in the control group.
This study was a randomized controlled trial according to the CONSORT guidelines. The sample comprised 55 men and 37 women (24 to 77 years old, mean ± standard deviation = 52.8 ± 11.13 years). The study settings included three tertiary hospitals in Changsha, Hunan, China. The 92 patients recruited were randomized into a control group and an intervention group. Instruments, including self-management behaviors, were assessed at the baseline, 2 days before discharge and after 1-, 3- and 6-month follow-up. The chi-squared test, independent sample t test, and repeated-measures analysis of variance were used to analyze the data.
Although ostomy-related surgery is a life-saving procedure in most cases, it inevitably elicits some complex and lifelong consequences, such as uncontrolled gas and stool emissions, disturbed patients' body images, and effects their social and sexual lives, which place heavy pressure on ostomy self-management.
Some studies have revealed the various ways that patients' lives are affected by their stoma, including changes to their quality of life, body image, and social life, requiring coping and practical adjustments. Others have shown that not enough attention has been paid to patients' self-management abilities, with most care being provided by nurses or caregivers, leaving little opportunities for patients to manage on their own. Consequently, their self-management ability after discharge remains weak, especially their related knowledge and skills. Studies have shown that 33.0-80.4% of patients with an ostomy cannot cope with the problems encountered in ostomy care.
Many scholars focused on the ability of early self-management in patients with an ostomy after discharge, and there were several issues in the field of stoma nursing care, such as insufficient discharge preparedness because of shortened hospital stays and a lack of systematic acquisition of related knowledge and skills. Others highlighted the paucity of attention paid to the post-discharge needs of patients with a stoma and a lack of formal training for follow-up.
Currently, self-management programs for patients with an ostomy mainly focus on the passive problem-solving model led by nurses and less emphasize has been placed on the self-assessment of patients who passively accept relevant knowledge and skills. This is insufficient for the pertinence, continuity, operability, and promotion of self-management. It is essential to call for a patient-tailored and theoretical approach to improve self-management and promote rehabilitation.
The transtheoretical model (TTM) is an empirically validated model of individual behavioral change, which involves progress through a series of stages to make a particular behavioral change. TTM-based interventions have been applied to facilitate health behavioral changes, such as physical exercise, smoking cessation, and weight management, studies of which continue to demonstrate positive effects. There have been few studies of patients with an ostomy using TTM as an interventional tool to provide continuous and dynamic education. Therefore, this study decided to investigate the use of an integrated method of incorporating TTM into patient instruction and to provide assistance to enhance the self-management ability of patients with an ostomy.
The aim of this study was to determine the effects of a transtheoretical model (TTM)-based intervention on ostomy self-management on patients' stages of change, processes of change, decisional balance, and self-efficacy. The study's hypotheses were: (1) There would be no significant difference between the intervention group and the control group before the intervention, and after intervention there would be more patients in the intervention group than those in the control groups. (2) Patients in the intervention group would achieve greater improvement in the ability of self-management than those in the control group.
This study was a randomized controlled trial according to the CONSORT guidelines. The sample comprised 55 men and 37 women (24 to 77 years old, mean ± standard deviation = 52.8 ± 11.13 years). The study settings included three tertiary hospitals in Changsha, Hunan, China. The 92 patients recruited were randomized into a control group and an intervention group. Instruments, including self-management behaviors, were assessed at the baseline, 2 days before discharge and after 1-, 3- and 6-month follow-up. The chi-squared test, independent sample t test, and repeated-measures analysis of variance were used to analyze the data.
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Detailed Description
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The study was a single blind, follow-up, randomized, controlled trial. Researchers recruited subjects from three Central South University-affiliated general tertiary hospitals in Changsha, Hunan province, China. And the whole trail was on the basis of the CONSORT statements. These three hospitals provided similar conventional care for patients with an ostomy. Study procedures were approved by the institutional review boards of all participating centers before data collection began. All patients were screened by researchers for eligibility and then enrolled in the study if eligible and if the provided consent.
Potential eligible participants were identified by researchers according to medical records at the colorectal surgery unit in each hospital. They were recruited with informed consent, and researchers explained the study purposes, procedures, benefits, and risks involved orally. The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list. A sequentially numbered and opaque , sealed envelope system was used by a non-investigator.
The generated random numbers were put into consecutively numbered and opaque sealed envelopes. When enrolling and randomising a new participant, the enrolling investigators opened the sealed envelope after participant's name was written on next available envelopes; the enrolling investigators were blinded to the trial design and study hypotheses.
Patients in the intervention group had access to conventional care, in addition to receiving the follow-up TTM-based intervention sessions. The intervention was provided by trained nurses, including one researcher and one enterostomal therapy (ET) nurse. The researcher was regarded as primary leader of the intervention sessions. The leader informed patients of the schedule for each session using the educational manual'All can do the same: a pro-change program for self-management of an ostomy' (developed by psychologists, nursing managers, experienced ET nurses, and researchers).
Sessions were held in the meeting room in the unit four times: at baseline (T0), 2 days before discharge (T1), and at 1-month (T2) and 3-months (T3) after discharge, according to the assessment of their current stage of change delivered by filling the Stages of Change Subscale.
No interventions were performed for the control group participants during the study. However, these patients received conventional care in the colorectal surgery units according to the three hospitals' similar nursing guidelines. Preoperative visits for brief psychological counseling and general postoperative health education for ostomy cleaning, stoma appliance use, and self-care skills were provided by ward nurses. Additionally, post-discharge telephone follow-up focused on an unstructured interview and general health inquiries. To minimize contamination bias, the health education was implemented to avoid simultaneous scheduling for the two groups.
Data were collected by a research assistant who was blind to the study design and allocation of participants. At baseline, before randomization, socio-demographic and clinical characteristics were collected from medical records and personal interviews. The two groups of participants completed surveys after each follow-up via face to face interviews at baseline (T0), 2 days before discharge (T1), and at 1-month (T2) and 3-months (T3) after discharge. The last evaluation of scales was performed at 6-months (T4) of follow-up via telephone contact.
Potential eligible participants were identified by researchers according to medical records at the colorectal surgery unit in each hospital. They were recruited with informed consent, and researchers explained the study purposes, procedures, benefits, and risks involved orally. The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list. A sequentially numbered and opaque , sealed envelope system was used by a non-investigator.
The generated random numbers were put into consecutively numbered and opaque sealed envelopes. When enrolling and randomising a new participant, the enrolling investigators opened the sealed envelope after participant's name was written on next available envelopes; the enrolling investigators were blinded to the trial design and study hypotheses.
Patients in the intervention group had access to conventional care, in addition to receiving the follow-up TTM-based intervention sessions. The intervention was provided by trained nurses, including one researcher and one enterostomal therapy (ET) nurse. The researcher was regarded as primary leader of the intervention sessions. The leader informed patients of the schedule for each session using the educational manual'All can do the same: a pro-change program for self-management of an ostomy' (developed by psychologists, nursing managers, experienced ET nurses, and researchers).
Sessions were held in the meeting room in the unit four times: at baseline (T0), 2 days before discharge (T1), and at 1-month (T2) and 3-months (T3) after discharge, according to the assessment of their current stage of change delivered by filling the Stages of Change Subscale.
No interventions were performed for the control group participants during the study. However, these patients received conventional care in the colorectal surgery units according to the three hospitals' similar nursing guidelines. Preoperative visits for brief psychological counseling and general postoperative health education for ostomy cleaning, stoma appliance use, and self-care skills were provided by ward nurses. Additionally, post-discharge telephone follow-up focused on an unstructured interview and general health inquiries. To minimize contamination bias, the health education was implemented to avoid simultaneous scheduling for the two groups.
Data were collected by a research assistant who was blind to the study design and allocation of participants. At baseline, before randomization, socio-demographic and clinical characteristics were collected from medical records and personal interviews. The two groups of participants completed surveys after each follow-up via face to face interviews at baseline (T0), 2 days before discharge (T1), and at 1-month (T2) and 3-months (T3) after discharge. The last evaluation of scales was performed at 6-months (T4) of follow-up via telephone contact.
Conditions
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Self-management
Self Efficacy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Patients in the intervention group had access to conventional care, in addition to receiving the follow-up TTM-based intervention sessions. The intervention was provided by trained nurses, including one researcher and one ET nurse. The researcher was regarded as primary leader of the intervention sessions. The leader informed patients of the schedule for each session using the educational manual 'we all can do the same: a pro-change program for self-management of an ostomy' (developed by psychologists, nursing managers, experienced ET nurses, and researchers).
No interventions were performed for the control group participants during the study. However, these patients received conventional care in the colorectal surgery units according to the three hospitals' similar nursing guidelines.
No interventions were performed for the control group participants during the study. However, these patients received conventional care in the colorectal surgery units according to the three hospitals' similar nursing guidelines.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Potential eligible participants were identified by researchers according to medical records at the colorectal surgery unit in each hospital. They were recruited with informed consent, and researchers explained the study purposes, procedures, benefits, and risks involved orally. The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list. The generated random numbers were put into consecutively numbered and opaque sealed envelopes. When enrolling and randomising a new participant, the enrolling investigators opened the sealed envelope after participant's name was written on next available envelopes. A sequentially numbered and opaque , sealed envelope system was used by a non-investigator. Additionally, all data collection was conducted by another research assistant who was blind to the study design and allocation of participants.
Study Groups
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The intervention group
Patients in the intervention group receiving the follow-up TTM-based intervention sessions.
Group Type
EXPERIMENTAL
Transtheoretical Model (TTM)-based Intervention
Intervention Type
BEHAVIORAL
Patients in the intervention group had access to conventional care, in addition to receiving the follow-up TTM-based intervention sessions. The intervention was provided by trained nurses, including one researcher and one ET nurse. Sessions were held in the meeting room in the unit four times: at baseline (T0), 2 days before discharge (T1), and at 1-month (T2) and 3-months (T3) after discharge, according to the assessment of their current stage of change delivered by filling the Stages of Change Subscale. Each face-to-face group contact lasted about 1 hour, depending on the complexity of the patients' problems.
The control group
No interventions except conventional care were performed for the control group.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Transtheoretical Model (TTM)-based Intervention
Patients in the intervention group had access to conventional care, in addition to receiving the follow-up TTM-based intervention sessions. The intervention was provided by trained nurses, including one researcher and one ET nurse. Sessions were held in the meeting room in the unit four times: at baseline (T0), 2 days before discharge (T1), and at 1-month (T2) and 3-months (T3) after discharge, according to the assessment of their current stage of change delivered by filling the Stages of Change Subscale. Each face-to-face group contact lasted about 1 hour, depending on the complexity of the patients' problems.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Had received surgical treatment with a permanent ostomy for the first time;
* Must be Conscious, with normal communication ability;
* Must be volunteered to join the study.
* Must be Conscious, with normal communication ability;
* Must be volunteered to join the study.
Exclusion Criteria
* Share a hospital room with a current study participant;
* With other types of cancer;
* Alcoholics and/or drug addicts;
* Disabilities and cannot take care of themselves
* With other types of cancer;
* Alcoholics and/or drug addicts;
* Disabilities and cannot take care of themselves
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Central South University
OTHER
Sponsor Role
lead
Responsible Party
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Shali Wen
Principal investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
References
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Ang SG, Chen HC, Siah RJ, He HG, Klainin-Yobas P. Stressors relating to patient psychological health following stoma surgery: an integrated literature review. Oncol Nurs Forum. 2013 Nov;40(6):587-94. doi: 10.1188/13.ONF.587-594.
Reference Type
BACKGROUND
Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J. Self-management approaches for people with chronic conditions: a review. Patient Educ Couns. 2002 Oct-Nov;48(2):177-87. doi: 10.1016/s0738-3991(02)00032-0.
Reference Type
BACKGROUND
van Leer E, Hapner ER, Connor NP. Transtheoretical model of health behavior change applied to voice therapy. J Voice. 2008 Nov;22(6):688-98. doi: 10.1016/j.jvoice.2007.01.011. Epub 2007 Dec 21.
Reference Type
BACKGROUND
McGuire S. World Cancer Report 2014. Geneva, Switzerland: World Health Organization, International Agency for Research on Cancer, WHO Press, 2015. Adv Nutr. 2016 Mar 15;7(2):418-9. doi: 10.3945/an.116.012211. Print 2016 Mar. No abstract available.
Reference Type
BACKGROUND
Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.
Reference Type
BACKGROUND
Popek S, Grant M, Gemmill R, Wendel CS, Mohler MJ, Rawl SM, Baldwin CM, Ko CY, Schmidt CM, Krouse RS. Overcoming challenges: life with an ostomy. Am J Surg. 2010 Nov;200(5):640-5. doi: 10.1016/j.amjsurg.2010.07.009.
Reference Type
BACKGROUND
Beaver K, Latif S, Williamson S, Procter D, Sheridan J, Heath J, Susnerwala S, Luker K. An exploratory study of the follow-up care needs of patients treated for colorectal cancer. J Clin Nurs. 2010 Dec;19(23-24):3291-300. doi: 10.1111/j.1365-2702.2010.03407.x. Epub 2010 Oct 22.
Reference Type
RESULT
Bohnenkamp SK, McDonald P, Lopez AM, Krupinski E, Blackett A. Traditional versus telenursing outpatient management of patients with cancer with new ostomies. Oncol Nurs Forum. 2004 Sep 17;31(5):1005-10. doi: 10.1188/04.ONF.1005-1010. Print 2004 Sep.
Reference Type
RESULT
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
Reference Type
RESULT
Coffey L, Mooney O, Dunne S, Sharp L, Timmons A, Desmond D, O'Sullivan E, Timon C, Gooberman-Hill R, Gallagher P. Cancer survivors' perspectives on adjustment-focused self-management interventions: a qualitative meta-synthesis. J Cancer Surviv. 2016 Dec;10(6):1012-1034. doi: 10.1007/s11764-016-0546-3. Epub 2016 May 5.
Reference Type
RESULT
Dabirian A, Yaghmaei F, Rassouli M, Tafreshi MZ. Quality of life in ostomy patients: a qualitative study. Patient Prefer Adherence. 2010 Dec 21;5:1-5. doi: 10.2147/PPA.S14508.
Reference Type
RESULT
Feng S, Liang Z, Zhang R, Liao W, Chen Y, Fan Y, Li H. Effects of mobile phone WeChat services improve adherence to corticosteroid nasal spray treatment for chronic rhinosinusitis after functional endoscopic sinus surgery: a 3-month follow-up study. Eur Arch Otorhinolaryngol. 2017 Mar;274(3):1477-1485. doi: 10.1007/s00405-016-4371-0. Epub 2016 Nov 7.
Reference Type
RESULT
Fanshawe TR, Halliwell W, Lindson N, Aveyard P, Livingstone-Banks J, Hartmann-Boyce J. Tobacco cessation interventions for young people. Cochrane Database Syst Rev. 2017 Nov 17;11(11):CD003289. doi: 10.1002/14651858.CD003289.pub6.
Reference Type
RESULT
Karabulut HK, Dinc L, Karadag A. Effects of planned group interactions on the social adaptation of individuals with an intestinal stoma: a quantitative study. J Clin Nurs. 2014 Oct;23(19-20):2800-13. doi: 10.1111/jocn.12541. Epub 2014 Jan 31.
Reference Type
RESULT
Lee JY, Park HA, Min YH. Transtheoretical Model-based Nursing Intervention on Lifestyle Change: A Review Focused on Intervention Delivery Methods. Asian Nurs Res (Korean Soc Nurs Sci). 2015 Jun;9(2):158-67. doi: 10.1016/j.anr.2015.05.001. Epub 2015 May 13.
Reference Type
RESULT
Lim SH, Chan SW, Lai JH, He HG. A randomized controlled trial examining the effectiveness of a STOMA psychosocial intervention programme on the outcomes of colorectal patients with a stoma: study protocol. J Adv Nurs. 2015 Jun;71(6):1310-23. doi: 10.1111/jan.12595. Epub 2014 Dec 15.
Reference Type
RESULT
Lim SH, Chan SW, He HG. Patients' Experiences of Performing Self-care of Stomas in the Initial Postoperative Period. Cancer Nurs. 2015 May-Jun;38(3):185-93. doi: 10.1097/NCC.0000000000000158.
Reference Type
RESULT
Lindfred H, Saalman R, Nilsson S, Sparud-Lundin C, Lepp M. Self-reported health, self-management, and the impact of living with inflammatory bowel disease during adolescence. J Pediatr Nurs. 2012 Jun;27(3):256-64. doi: 10.1016/j.pedn.2011.02.005. Epub 2011 Mar 30.
Reference Type
RESULT
Marcus BH, Dubbert PM, Forsyth LH, McKenzie TL, Stone EJ, Dunn AL, Blair SN. Physical activity behavior change: issues in adoption and maintenance. Health Psychol. 2000 Jan;19(1S):32-41. doi: 10.1037/0278-6133.19.suppl1.32.
Reference Type
RESULT
Raingruber B. The effectiveness of psychosocial interventions with cancer patients: an integrative review of the literature (2006-2011). ISRN Nurs. 2011;2011:638218. doi: 10.5402/2011/638218. Epub 2011 Nov 16.
Reference Type
RESULT
Richard AA, Shea K. Delineation of self-care and associated concepts. J Nurs Scholarsh. 2011 Sep;43(3):255-64. doi: 10.1111/j.1547-5069.2011.01404.x. Epub 2011 Jul 25.
Reference Type
RESULT
Richbourg L, Thorpe JM, Rapp CG. Difficulties experienced by the ostomate after hospital discharge. J Wound Ostomy Continence Nurs. 2007 Jan-Feb;34(1):70-9. doi: 10.1097/00152192-200701000-00011.
Reference Type
RESULT
Rosenberg CA, Flanagan C, Brockstein B, Obel JC, Dragon LH, Merkel DE, Wade EL, Law TM, Khandekar JD, Hensing TA. Promotion of self-management for post treatment cancer survivors: evaluation of a risk-adapted visit. J Cancer Surviv. 2016 Feb;10(1):206-19. doi: 10.1007/s11764-015-0467-6. Epub 2015 Jul 16.
Reference Type
RESULT
Spencer L, Adams TB, Malone S, Roy L, Yost E. Applying the transtheoretical model to exercise: a systematic and comprehensive review of the literature. Health Promot Pract. 2006 Oct;7(4):428-43. doi: 10.1177/1524839905278900. Epub 2006 Jul 13.
Reference Type
RESULT
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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JLI
Identifier Type: -
Identifier Source: org_study_id
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