Self-managementNCT03681821
Effects of Transtheoretical Model-based Intervention on the Self-management of Patients With an Ostomy
A study testing Transtheoretical Model (TTM)-based Intervention in people with Self-management and Self Efficacy, run by Central South University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self-management, Self Efficacy
- What is being tested?
- Transtheoretical Model (TTM)-based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2012to 31 Mar 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Effects of Transtheoretical Model-based Intervention on the Self-management of Patients With an Ostomy: a Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Self-management, Self Efficacy
- Being tested
- Transtheoretical Model (TTM)-based Intervention
- Keywords
- ostomy, self-management, self-efficacy, health-promoting behavior
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtheoretical Model (TTM)-based InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | Patients in the intervention group receiving the follow-up TTM-based intervention sessions. Receives: Behavioral: Transtheoretical Model (TTM)-based Intervention |
| The control group | No intervention | No interventions except conventional care were performed for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline the stages of change at 3 months
There were four subscales in the study, the stages of change subscale, the processes of change subscale, the decisional balance subscale, and the self-efficacy subscale.
The outcome 1 was measured by the stages of change subscale and aimed to determine changes from baseline the percentage of participants of stages of change at 3 months. This subscale consisted of one item: 'Would you participant in self-management behavior of ostomy regularly?), which assess the patients' stages of self-management behavioral change, with five statements representing each stage: precontemplation, contemplation, preparation, action, and maintenance. Patients were asked to select one suitable statement that exactly described their current condition of ostomy self-management .
Measured: 3-months (T3) after discharge
Change from baseline the scores of the processes of change at 3 months
The outcome 2 was measured by the stages of change subscale and aimed to determine changes from baseline the scores of the processes of change subscale at 3 months. This subscale was used to assess whether patients have had any activities or experiences that can affect their self-management of ostomy. It comprised 23 items and two dimensions, including cognitive level and behavioral level. Each individual item was scored from 1 (never) to 5 (always), with higher scores indicating higher frequency use of the process. The Cronbach values of the two dimensions were 0.958 and 0.905 respectively.
Measured: 3-months (T3) after discharge
Change from baseline the scores of decisional balance at 3 months
The outcome 3 was measured by the stages of change subscale and aimed to determine changes from baseline the scores of decisional balance subscale at 3 months. This subscale was developed to assess patients' various points of view on the method of ostomy self-management that they had undertaken. It covered two dimensions of 20 items including perceived benefits and perceived barriers. Each item was ranked on a five-point Likert scale ranging from 1 (absolutely disagree) to 5 (absolutely agree). A higher score indicates a greater degree of agreement. The Cronbach's value of the perceived benefits and perceived barriers were 0.895 and 0.717, respectively.
Measured: 3-months (T3) after discharge
Change from baseline the scores of self-efficacy at 3 months
The outcome 4 was measured by the stages of change subscale and aimed to determine changes from baseline the scores of self-efficacy subscale at 3 months. The scale consisted of eight items and aimed to assess patients' confidence in self-management. Each item is evaluated on a Likert-type scale (1-5). A higher score indicated stronger self-confidence. In this study, the Cronbach's coefficient level of the scale was 0.966 .
Measured: 3-months (T3) after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Aug 2012
- Primary completion30 Sep 2012
- Study completion31 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Self-managementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shali Wen, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681821
- Sponsor's protocol ID
- JLI
- Status last verified
- Sep 2018
- First submitted
- 14 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The process of data collection cost a lot of human and material resources, some of the data was privacy information of participants, and so on. Considering this, it is improper to share these data.
Publications
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.
PubMed 24161637Barlow 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.
PubMed 12401421van 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.
PubMed 18082367McGuire 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.
PubMed 26980827Parkin 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.
PubMed 15761078Popek 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.
PubMed 21056145Beaver 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.
PubMed 20964750Bohnenkamp 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.
PubMed 15378102Chen 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.
PubMed 26808342Coffey 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.
PubMed 27150211Dabirian 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.
PubMed 21311696Feng 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.
PubMed 27822702Fanshawe 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.
PubMed 29148565Karabulut 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.
PubMed 24479766Lee 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.
PubMed 26160246
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transtheoretical Model-based Intervention on the Self-management of Patients With an Ostomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03681821
- Acronym / sponsor ID
- JLI
- Conditions
- Self-management, Self Efficacy
- Keywords
- ostomy, self-management, self-efficacy, health-promoting behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 30 Sep 2012 (actual)
- Study completion
- 31 Mar 2013 (actual)
- First posted
- 24 Sep 2018 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: Transtheoretical Model (TTM)-based InterventionPatients in the intervention group receiving the follow-up TTM-based intervention sessions. |
| The control group | No intervention | –No interventions except conventional care were performed for the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Transtheoretical Model (TTM)-based InterventionPatients 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. | Behavioural | The intervention group |
Primary outcome
Change from baseline the stages of change at 3 months
Time frame: 3-months (T3) after discharge
There were four subscales in the study, the stages of change subscale, the processes of change subscale, the decisional balance subscale, and the self-efficacy subscale. The outcome 1 was measured by the stages of change subscale and aimed to determine changes from baseline the percentage of participants of stages of change at 3 months. This subscale consisted of one item: 'Would you participant in self-management behavior of ostomy regularly?), which assess the patients' stages of self-management behavioral change, with five statements representing each stage: precontemplation, contemplation, preparation, action, and maintenance. Patients were asked to select one suitable statement that exactly described their current condition of ostomy self-management .
Change from baseline the scores of the processes of change at 3 months
Time frame: 3-months (T3) after discharge
The outcome 2 was measured by the stages of change subscale and aimed to determine changes from baseline the scores of the processes of change subscale at 3 months. This subscale was used to assess whether patients have had any activities or experiences that can affect their self-management of ostomy. It comprised 23 items and two dimensions, including cognitive level and behavioral level. Each individual item was scored from 1 (never) to 5 (always), with higher scores indicating higher frequency use of the process. The Cronbach values of the two dimensions were 0.958 and 0.905 respectively.
Change from baseline the scores of decisional balance at 3 months
Time frame: 3-months (T3) after discharge
The outcome 3 was measured by the stages of change subscale and aimed to determine changes from baseline the scores of decisional balance subscale at 3 months. This subscale was developed to assess patients' various points of view on the method of ostomy self-management that they had undertaken. It covered two dimensions of 20 items including perceived benefits and perceived barriers. Each item was ranked on a five-point Likert scale ranging from 1 (absolutely disagree) to 5 (absolutely agree). A higher score indicates a greater degree of agreement. The Cronbach's value of the perceived benefits and perceived barriers were 0.895 and 0.717, respectively.
Change from baseline the scores of self-efficacy at 3 months
Time frame: 3-months (T3) after discharge
The outcome 4 was measured by the stages of change subscale and aimed to determine changes from baseline the scores of self-efficacy subscale at 3 months. The scale consisted of eight items and aimed to assess patients' confidence in self-management. Each item is evaluated on a Likert-type scale (1-5). A higher score indicated stronger self-confidence. In this study, the Cronbach's coefficient level of the scale was 0.966 .
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 24 Sep 2018.
- Background: PubMed 24161637Ang 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.
- Background: PubMed 12401421Barlow 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.
- Background: PubMed 18082367van 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.
- Background: PubMed 26980827McGuire 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.
- Background: PubMed 15761078Parkin 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.
- Background: PubMed 21056145Popek 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.
- Results publication: PubMed 20964750Beaver 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.
- Results publication: PubMed 15378102Bohnenkamp 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.
- Results publication: PubMed 26808342Chen 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.
- Results publication: PubMed 27150211Coffey 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.
- Results publication: PubMed 21311696Dabirian 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.
- Results publication: PubMed 27822702Feng 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.
- Individual participant dataSharing planned: No. The process of data collection cost a lot of human and material resources, some of the data was privacy information of participants, and so on. Considering this, it is improper to share these data.
Related trials for Self-management
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Not yet recruiting
A Nurse-Led Personalized Self-Management Counseling Intervention to Improve Medication Adherence and Glycemic Control in Adults With Type 2 Diabetes: A Randomized Controlled Trial
Medication Adherence, Glycemic Control for Diabetes Mellitus
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transtheoretical Model (TTM)-based Intervention in people with Self-management and Self Efficacy, run by Central South University.
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 3 inclusion and 4 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 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline the stages of change at 3 months (time frame: 3-months (T3) after discharge). The study lists 4 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 NCT03681821, which also lists 24 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 24 Sep 2018.