Quality of LifeNCT04735991
A Real-world Clinical Study of Kapok Initiative
A study testing Kapok Initiative in people with Quality of Life, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a prospective and effective research study. The aim is to assess the difference in the quality of life of the family members of patients with colorectal cancer after application of follow-up disease management using mobile network terminals and routine clinical treatment follow-up management. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Kapok Initiative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2020to Oct 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Subject: The main family members caring for patients are ≥18 and ≤65 years old;
- (2) Family members of patients who can understand the purpose of the study, voluntarily participate and sign an informed consent form, and are willing to complete follow-up as required by the protocol;
- (3) Family members of colorectal cancer patients who need to receive adjuvant chemotherapy XELOX regimen within 6 months after initial diagnosis of high-risk stage II or stage III
Who cannot join
- (1) Patient life expectancy is less than 3 months
- (2) Family members of patients cannot use electronic mobile products
- (3) The family of the patient has a history of malignant tumors or other serious diseases
- (4) Family members of patients are considered unsuitable by the researcher
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Beijing, 100021
About this study
Official title: A Real-world Clinical Study Evaluating the Quality of Life in Family Members of Colorectal Cancer Patients Based on a Whole Course Chronic Disease Management System for Cancer Patients' Family
This study is a prospective and effective research study. The aim is to assess the difference in the quality of life of the family members of patients with colorectal cancer after application of follow-up disease management using mobile network terminals and routine clinical treatment follow-up management. The hypothesis is that the application of mobile-based disease management system significantly improves the quality of life of the patients' family members, thereby improving the quality of life of the patients' families.
Approximately 100 families of colorectal cancer patients who had been diagnosed as high-risk stage II or stage III and required adjuvant chemotherapy XELOX regimen within 6 months after initial diagnosis were randomly assigned to the control and study groups at a 1: 1 ratio, with approximately 50 cases in the control group and about 50 patients in the study group. The reason for choosing these tumors is because the patients with these tumors will present a series of clinical symptoms during the treatment, which requires family members to take care of them. All patient and their family demographics, questionnaires on quality of life of patient's family, adverse events and other information will be collected.
Read more
The study uses a network-centric randomization system. In the randomization process, stratified randomization will be carried out according to the education level of the patient's family members (junior college degree or above vs. below college degree). The family members of the patients participating in the study will be randomly assigned to the tumor patient management platform or clinical routine treatment follow-up group.
Family members of all patients will be followed up to 2 months after randomization, or withdrew from the study (with the preceding events as the end point). Unless the patient's family member withdraws from the study, lost to follow-up, or the study is terminated, the patient is considered to be in the study. Family members of patients who are randomly assigned to the full management platform need to participate in a 60 minutes concentrated training session for 27 days, taught by experts online. The content of the lectures includes medical treatment guidelines, pain relief, family rehabilitation, family communication, family roles, early screening prevention, Medical insurance and other aspects. The contents of the online courses are: 1) Doctors are also mortal; 2) New medicines and new therapies; 3) Alternative therapies; 4) Don't panic during the operation; 5) Pain relief; 6) Side effects of treatment; 8) About the truth; 9) New topics; 10) Anti-cancer cost-effectiveness; 11) Medical insurance; 12) Commercial medical insurance; 13) Exercise and rehabilitation; 14) Nutrition and Foods to increase leukocytes level ; 15) Long-term persistence; 16) Acceptance Change; 17) Two new roles; 18) Future expectation.
- Conditions
- Quality of Life
- Being tested
- Kapok Initiative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kapok InitiativeBehavioural
The detailed process is:
- After randomization, the Kapok assistant will contact the patient's family
- The family of the patient joins the "Kapok Initiative". They will participate in a 60-minute training program for 27 days, which is taught online by experts; The contents of the lectures are as follows: 1) Doctors are also mortal; 2) New medicines and new therapies; 3) Alternative therapies; 4) Don't panic during the operation; 5) Pain relief; 6) Side effects of treatment; 8) About the truth; 9) New topics; 10) Anti-cancer cost-effectiveness; 11) Medical insurance; 12) Commercial medical insurance; 13) Exercise and rehabilitation; 14) Nutrition and Foods to increase leukocytes level; 15) Long-term persistence; 16) Acceptance Change; 17) Two new roles; 18) Future expectation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The patient's family members need to fill in the family member quality of life questionnaire during the screening and follow-up period. They are able to contact the doctor for questions in terms of medical treatment. |
| Study group | Experimental | The family members of the patients need to fill in the family member quality of life questionnaire during the screening period and follow-up period, and are involved in an interactive management program on the mobile terminal, full participation required. Receives: Behavioral: Kapok Initiative |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the difference in the quality of life of the family members of patients with colorectal cancer after application of follow-up disease management using mobile network terminals and routine clinical treatment follow-up management.
First of all, The Cronbach's α coefficient of the QOLLTI-F family quality of life questionnaire that is used in this study will be calculated; then the minimum, maximum, median (quartile) and mean (standard deviation) of the quality of life scores of the family members of the study group and the control group will be determined; finally we will use t test to compare the scores to investigate whether there is a difference in the quality of life score between two groups; in order to eliminate the influence of confounding factors (such as age, gender, education level, etc.) on the main research results, several common influencing factors will be selected to construct a covariance analysis regression model to assess whether the intervention strategy of this study has an impact on the quality of life of patients' family members.
Measured: 1 Month
Secondary outcomes (5)
To assess the difference in quality of life of subjects (family of patients) with different educational levels
Patients' families are grouped based on their educational level, and the minimum, maximum, median (quartile), and mean (standard deviation) of the scores of quality of life questionnaire of each group will be calculated; Analysis of variance will be used to compare whether there are differences in the quality of life scores of patients' families among different education levels. If a general difference occurs, the Bonferroni method will be used to further perform multiple comparisons. At the same time, the Kruskal-Wallis rank-sum test will be used to compare the overall differences between the groups and the Steel-Dwass-Critchlow-Fligner test will be used for further multiple comparisons.
Measured: 1 Month
To assess the difference in the quality of life of the relationship between the subject (patient's family member) and the patient
The subjects will be grouped according to the relationship between the subjects (families of patients) and patients. The minimum, maximum, median (quartile), and mean (standard deviation) of the scores of quality of life questionnaire of each group will be calculated; Analysis of variance will be used to compare whether there are differences in the quality of life scores of patients' families among different education levels. If a general difference occurs, the Bonferroni method will be used to further perform multiple comparisons. At the same time, the Kruskal-Wallis rank-sum test will be used to compare the overall differences between the groups and the Steel-Dwass-Critchlow-Fligner test will be used for further multiple comparisons.
Measured: 1 Month
To assess the difference in quality of life of the subjects (family of patients) with difference length of time spent taking care of the patients daily
The minimum, maximum, median (quartile), and mean (standard deviation) of the scores of quality of life questionnaire based on difference length of time spent on daily care will be calculated; Analysis of variance will be used to compare whether there are differences in the quality of life scores of patients' families among different education levels. If a general difference occurs, the Bonferroni method will be used to further perform multiple comparisons. At the same time, the Kruskal-Wallis rank-sum test will be used to compare the overall differences between the groups and the Steel-Dwass-Critchlow-Fligner test will be used for further multiple comparisons.
Measured: 1 Month
To assess the differences in patients' quality of life
First of all, The Cronbach's α coefficient of the EORTC QLQ-C30 patient quality of life questionnaire that is used in this study will be calculated; then the minimum, maximum, median (quartile) and mean (standard deviation) of the quality of life scores of patients of the study group and the control group will be determined; we will use t test to compare the scores to investigate whether two groups are statistically different in each field. Finally, several common influencing factors will be selected to construct a covariance analysis regression model to assess whether the scores of the quality of life of the two groups are statistically different in various fields.
Measured: 1 Month
To assess the difference in the quality of life of the subjects (family of patients) 2 months after follow-up management.
The minimum, maximum, median (quartile) and mean (standard deviation) of the quality of life scores of the family members of the study group and the control group patients after 2 months of follow-up are calculated; T test will be used to compare whether there is a difference in the quality of life score between two groups; then several common influencing factors will be selected to construct a covariance analysis regression model to assess whether the quality of life scores of the two groups of patients are statistically different after 2 months of follow-up.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start8 May 2020
- Primary completionSep 2021 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: The recruitment process is affected by the coronavirus pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- QTC care
- Responsible party
- Principal investigator, Aiping Zhou, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735991
- Sponsor's protocol ID
- LZMMH-2020
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He Jie, Zhao Ping, Chen Wanqing. China tumor registration report in 2012[M]. Beijing: Military Medical Science Press, 2012:1-302.
Borji M, Nourmohammadi H, Otaghi M, Salimi AH, Tarjoman A. Positive Effects of Cognitive Behavioral Therapy on Depression, Anxiety and Stress of Family Caregivers of Patients with Prostate Cancer: A Randomized Clinical Trial. Asian Pac J Cancer Prev. 2017 Dec 28;18(12):3207-3212. doi: 10.22034/APJCP.2017.18.12.3207.
PubMed 29281868梁文珍，谭文娟，舒放, 癌症患者家属心理健康状态的调查［J］, 临床 心身疾病杂志，2008，14（2）：136 _ 138
陈冰芳, 实施家属健康教育对鼻咽癌放疗病人生活质量的影响［J］, 护理研究，2010，24，（10c）：2220 _ 2221
Greer JA, Jacobs J, Pensak N, MacDonald JJ, Fuh CX, Perez GK, Ward A, Tallen C, Muzikansky A, Traeger L, Penedo FJ, El-Jawahri A, Safren SA, Pirl WF, Temel JS. Randomized Trial of a Tailored Cognitive-Behavioral Therapy Mobile Application for Anxiety in Patients with Incurable Cancer. Oncologist. 2019 Aug;24(8):1111-1120. doi: 10.1634/theoncologist.2018-0536. Epub 2019 Jan 25.
PubMed 30683710Kim Y, Schulz R. Family caregivers' strains: comparative analysis of cancer caregiving with dementia, diabetes, and frail elderly caregiving. J Aging Health. 2008 Aug;20(5):483-503. doi: 10.1177/0898264308317533. Epub 2008 Apr 17.
PubMed 18420838Chen W, Sun K, Zheng R, Zeng H, Zhang S, Xia C, Yang Z, Li H, Zou X, He J. Cancer incidence and mortality in China, 2014. Chin J Cancer Res. 2018 Feb;30(1):1-12. doi: 10.21147/j.issn.1000-9604.2018.01.01.
PubMed 29545714Cohen R, Leis AM, Kuhl D, Charbonneau C, Ritvo P, Ashbury FD. QOLLTI-F: measuring family carer quality of life. Palliat Med. 2006 Dec;20(8):755-67. doi: 10.1177/0269216306072764.
PubMed 17148530Alnjadat, R. M., Wan Adnan, W. A., & Ismail, Z. (2014). Psychometric properties of the QOLLTI-F questionnaire to assess quality of life in caregivers of cancer patients. Education in Medicine Journal, 6(2).doi:10.5959/eimj.v6i2.217
肖惠敏, 郑建伟, 兰秀燕. 晚期癌症患者生存质量对家庭照顾者生存质量的影响The impact of advanced cancer patients' quality of life on family caregivers' quality of life[J]. 中华护理杂志, 2015, 050(004):415-419
杨理, 刘伟, 邓映, et al. 血液肿瘤患儿家庭照顾者生活质量与家庭环境的相关性分析[J]. 国际护理学杂志, 2018, 37(18):2520-2524
Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer. 1994;30A(5):635-42. doi: 10.1016/0959-8049(94)90535-5.
PubMed 8080679Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Fayers P, Bottomley A; EORTC Quality of Life Group; Quality of Life Unit. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2002 Mar;38 Suppl 4:S125-33. doi: 10.1016/s0959-8049(01)00448-8.
PubMed 11858978
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Clinical Study Evaluating the Quality of Life in Family Members of Colorectal Cancer Patients Based on a Whole Course Chronic Disease Management System for Cancer Patients' Family
- ClinicalTrials.gov ID
- NCT04735991
- Acronym / sponsor ID
- LZMMH-2020
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The recruitment process is affected by the coronavirus pandemic.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- QTC care
- Study start
- 8 May 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 3 Feb 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.
This study is a prospective and effective research study. The aim is to assess the difference in the quality of life of the family members of patients with colorectal cancer after application of follow-up disease management using mobile network terminals and routine clinical treatment follow-up management. The hypothesis is that the application of mobile-based disease management system significantly improves the quality of life of the patients' family members, thereby improving the quality of life of the patients' families.
Approximately 100 families of colorectal cancer patients who had been diagnosed as high-risk stage II or stage III and required adjuvant chemotherapy XELOX regimen within 6 months after initial diagnosis were randomly assigned to the control and study groups at a 1: 1 ratio, with approximately 50 cases in the control group and about 50 patients in the study group. The reason for choosing these tumors is because the patients with these tumors will present a series of clinical symptoms during the treatment, which requires family members to take care of them. All patient and their family demographics, questionnaires on quality of life of patient's family, adverse events and other information will be collected.
The study uses a network-centric randomization system. In the randomization process, stratified randomization will be carried out according to the education level of the patient's family members (junior college degree or above vs. below college degree). The family members of the patients participating in the study will be randomly assigned to the tumor patient management platform or clinical routine treatment follow-up group.
Family members of all patients will be followed up to 2 months after randomization, or withdrew from the study (with the preceding events as the end point). Unless the patient's family member withdraws from the study, lost to follow-up, or the study is terminated, the patient is considered to be in the study. Family members of patients who are randomly assigned to the full management platform need to participate in a 60 minutes concentrated training session for 27 days, taught by experts online. The content of the lectures includes medical treatment guidelines, pain relief, family rehabilitation, family communication, family roles, early screening prevention, Medical insurance and other aspects. The contents of the online courses are: 1) Doctors are also mortal; 2) New medicines and new therapies; 3) Alternative therapies; 4) Don't panic during the operation; 5) Pain relief; 6) Side effects of treatment; 8) About the truth; 9) New topics; 10) Anti-cancer cost-effectiveness; 11) Medical insurance; 12) Commercial medical insurance; 13) Exercise and rehabilitation; 14) Nutrition and Foods to increase leukocytes level ; 15) Long-term persistence; 16) Acceptance Change; 17) Two new roles; 18) Future expectation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The patient's family members need to fill in the family member quality of life questionnaire during the screening and follow-up period. They are able to contact the doctor for questions in terms of medical treatment. |
| Study group | Experimental | Behavioral: Kapok InitiativeThe family members of the patients need to fill in the family member quality of life questionnaire during the screening period and follow-up period, and are involved in an interactive management program on the mobile terminal, full participation required. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) Subject: The main family members caring for patients are ≥18 and ≤65 years old;
- (2) Family members of patients who can understand the purpose of the study, voluntarily participate and sign an informed consent form, and are willing to complete follow-up as required by the protocol;
- (3) Family members of colorectal cancer patients who need to receive adjuvant chemotherapy XELOX regimen within 6 months after initial diagnosis of high-risk stage II or stage III
Key exclusion criteria (4 listed)
- (1) Patient life expectancy is less than 3 months
- (2) Family members of patients cannot use electronic mobile products
- (3) The family of the patient has a history of malignant tumors or other serious diseases
- (4) Family members of patients are considered unsuitable by the researcher
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 |
|---|---|---|
| Kapok InitiativeThe detailed process is: 1. After randomization, the Kapok assistant will contact the patient's family 2. The family of the patient joins the "Kapok Initiative". They will participate in a 60-minute training program for 27 days, which is taught online by experts; The contents of the lectures are as follows: 1) Doctors are also mortal; 2) New medicines and new therapies; 3) Alternative therapies; 4) Don't panic during the operation; 5) Pain relief; 6) Side effects of treatment; 8) About the truth; 9) New topics; 10) Anti-cancer cost-effectiveness; 11) Medical insurance; 12) Commercial medical insurance; 13) Exercise and rehabilitation; 14) Nutrition and Foods to increase leukocytes level; 15) Long-term persistence; 16) Acceptance Change; 17) Two new roles; 18) Future expectation. | Behavioural | Study group |
Primary outcome
To assess the difference in the quality of life of the family members of patients with colorectal cancer after application of follow-up disease management using mobile network terminals and routine clinical treatment follow-up management.
Time frame: 1 Month
First of all, The Cronbach's α coefficient of the QOLLTI-F family quality of life questionnaire that is used in this study will be calculated; then the minimum, maximum, median (quartile) and mean (standard deviation) of the quality of life scores of the family members of the study group and the control group will be determined; finally we will use t test to compare the scores to investigate whether there is a difference in the quality of life score between two groups; in order to eliminate the influence of confounding factors (such as age, gender, education level, etc.) on the main research results, several common influencing factors will be selected to construct a covariance analysis regression model to assess whether the intervention strategy of this study has an impact on the quality of life of patients' family members.
5 secondary outcomes
To assess the difference in quality of life of subjects (family of patients) with different educational levels
Time frame: 1 Month
To assess the difference in the quality of life of the relationship between the subject (patient's family member) and the patient
Time frame: 1 Month
To assess the difference in quality of life of the subjects (family of patients) with difference length of time spent taking care of the patients daily
Time frame: 1 Month
To assess the differences in patients' quality of life
Time frame: 1 Month
To assess the difference in the quality of life of the subjects (family of patients) 2 months after follow-up management.
Time frame: 2 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- BackgroundHe Jie, Zhao Ping, Chen Wanqing. China tumor registration report in 2012[M]. Beijing: Military Medical Science Press, 2012:1-302.
- Background: PubMed 29281868Borji M, Nourmohammadi H, Otaghi M, Salimi AH, Tarjoman A. Positive Effects of Cognitive Behavioral Therapy on Depression, Anxiety and Stress of Family Caregivers of Patients with Prostate Cancer: A Randomized Clinical Trial. Asian Pac J Cancer Prev. 2017 Dec 28;18(12):3207-3212. doi: 10.22034/APJCP.2017.18.12.3207.
- Background梁文珍，谭文娟，舒放, 癌症患者家属心理健康状态的调查［J］, 临床 心身疾病杂志，2008，14（2）：136 _ 138
- Background陈冰芳, 实施家属健康教育对鼻咽癌放疗病人生活质量的影响［J］, 护理研究，2010，24，（10c）：2220 _ 2221
- Background: PubMed 30683710Greer JA, Jacobs J, Pensak N, MacDonald JJ, Fuh CX, Perez GK, Ward A, Tallen C, Muzikansky A, Traeger L, Penedo FJ, El-Jawahri A, Safren SA, Pirl WF, Temel JS. Randomized Trial of a Tailored Cognitive-Behavioral Therapy Mobile Application for Anxiety in Patients with Incurable Cancer. Oncologist. 2019 Aug;24(8):1111-1120. doi: 10.1634/theoncologist.2018-0536. Epub 2019 Jan 25.
- Background: PubMed 18420838Kim Y, Schulz R. Family caregivers' strains: comparative analysis of cancer caregiving with dementia, diabetes, and frail elderly caregiving. J Aging Health. 2008 Aug;20(5):483-503. doi: 10.1177/0898264308317533. Epub 2008 Apr 17.
- Background: PubMed 29545714Chen W, Sun K, Zheng R, Zeng H, Zhang S, Xia C, Yang Z, Li H, Zou X, He J. Cancer incidence and mortality in China, 2014. Chin J Cancer Res. 2018 Feb;30(1):1-12. doi: 10.21147/j.issn.1000-9604.2018.01.01.
- Background: PubMed 17148530Cohen R, Leis AM, Kuhl D, Charbonneau C, Ritvo P, Ashbury FD. QOLLTI-F: measuring family carer quality of life. Palliat Med. 2006 Dec;20(8):755-67. doi: 10.1177/0269216306072764.
- BackgroundAlnjadat, R. M., Wan Adnan, W. A., & Ismail, Z. (2014). Psychometric properties of the QOLLTI-F questionnaire to assess quality of life in caregivers of cancer patients. Education in Medicine Journal, 6(2).doi:10.5959/eimj.v6i2.217
- Background肖惠敏, 郑建伟, 兰秀燕. 晚期癌症患者生存质量对家庭照顾者生存质量的影响The impact of advanced cancer patients' quality of life on family caregivers' quality of life[J]. 中华护理杂志, 2015, 050(004):415-419
- Background杨理, 刘伟, 邓映, et al. 血液肿瘤患儿家庭照顾者生活质量与家庭环境的相关性分析[J]. 国际护理学杂志, 2018, 37(18):2520-2524
- Background: PubMed 8080679Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer. 1994;30A(5):635-42. doi: 10.1016/0959-8049(94)90535-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kapok Initiative in people with Quality of Life, run by Chinese Academy of Medical Sciences at 1 site in China.
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: paused, as of the sponsor's last update on 3 Feb 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 China. 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?
Results are not available in the source record.
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?
To assess the difference in the quality of life of the family members of patients with colorectal cancer after application of follow-up disease management using mobile network terminals and routine clinical treatment follow-up management. (time frame: 1 Month). 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 NCT04735991, which also lists 14 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 3 Feb 2021.