- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06179914
Resilience Models in Adolescence and Youth With Cancer in Taiwan
December 12, 2023 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Validation of Resilience Models About Cancer in Adolescence and Youth in Taiwan
Validation of Resilience Models about Cancer in Adolescence and Youth in Taiwan
Study Overview
Status
Completed
Conditions
Detailed Description
This study uses the disease resilience model as a framework to explore the relationship between physical, mental, spiritual, and social aspects of resilience in adolescents with cancer and to verify the resilience model.
It is expected that the research results will serve as a reference for designing nursing interventions in the future and develop local Resilience model to improve quality of care.
Study Type
Observational
Enrollment (Actual)
223
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 80361
- Kaohsiung Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
childhood cancer at age between 10 and 24
Description
Inclusion Criteria
- Diagnosed with cancer before 18 years old
- Aged between 10 and 24 years
- Received cancer treatment or completed treatment
Exclusion Criteria:
- Diagnosis of mental problems (developmental delay or psychiatric illness)
- At the end of life
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Adolescence and Youth with cancer
Participants were diagnosed with cancer before 18 years old and aged between 10 and 24 years
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Herth Hope Index (HHI)
Time Frame: 1 year
|
Herth Hope Index (HHI) has 12 items.
The12 items developed by Herth (1992) measures adults hope and contains three factors: cognitive-temporal (positive and desired outcome in the future), affective-behavioral (a feeling of confident with the reality-based goals and desirable outcomes), and affiliative-contextual (interconnect between self and others)(Herth, 1992).
A higher score indicates a higher degree of hope.
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1 year
|
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Resilience in Illness Scale (HARS)
Time Frame: 1 year
|
HARS is a single factor scale, consisting of 13 items that measure how participants feel or think about managing their health since diagnosis.
The internal consistency reliability (0.84 to 0.86) and content validity have been tested by previous qualitative research (Haase & Marcia, 1994; Haase & Philips, 2004).
Participants are asked to mark how much they agree or disagree with each sentence using response options from 1 (strongly disagree) to 6 (strongly agree) (Haase, et al., 1999).
Higher total scores indicate a higher degree of resilience.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom Distress Scale (SDS)
Time Frame: 1 year
|
SDS is developed from McCorkle & Young (1978), with a total of 13 questions, using a 1-5 scoring method.
Higher of the total score, the higher the degree of symptom distress.
The reliability of the instrument (r=.79-.89), using Ware's health perception scale test (r=0.9)
(McCorkle, 1978).
The reliability of the revised Chinese version is (Cronbach's α =.91-.96),
the content validity index (CVI) is 0.95, and the readability is 0.95 (Lai, 1998).
Higher total scores indicate a higher degree of symptom distress.
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1 year
|
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mishel Uncertainty in Illness Scale - Revised
Time Frame: 1 year
|
It is developed from the uncertainty scale developed by Mishel, 1981, with a total of 33 questions.
The reliability of the instrument is 0.91.
The reliability of each scale ranges from 0.64-0.89,
and its validity has been verified through theory (Mishel, 1981).
The internal consistency reliability of the Chinese version of the literature is Cronbach's α =0.87, the internal consistency of the subscales is 0.85 and 0.66, and the simultaneous validity is 0.571 (Xu & Huang, 1996).
Higher total scores indicate a higher degree of uncertainty.
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1 year
|
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Jalowiec Coping Scale-Revised
Time Frame: 1 year
|
It is developed from Jalowiec et al, (1984).
There are 40 items.
The test-retest reliability of the instrument is 0.79.
The internal consistency within the subscale is between 0.85-0.86.
The total scale α=0.78 and the subscale is 0.84 (question solution), 0.83 (defensive behavior) (Jalowiec et al, 1984).Higher total scores indicate a higher frequency of used coping behaviors.
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1 year
|
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Spiritual Perspective Scale (SPS)
Time Frame: 1 year
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The SPS was developed from Jalowiec et al, (1984).
There are 40 questions in total.
The test-retest reliability of the instrument is 0.79.
The internal consistency within the subscale is between 0.85-0.86.
The total scale α=0.78 and the subscale is 0.84 (question solution), 0.83 (defensive behavior) (Jalowiec et al, 1984).
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1 year
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Perceived Social Support (PSS)
Time Frame: 1 year
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It is developed from the Perceived Family Support Scale of Procidano & Heller (1983).
The scale has 20 questions and Cronbach's alpha reliability coefficients are .88
and 0.91 (Procidano & Heller, 1983; Puskar & Bernardo, Stark, 2008).Higher total scores indicate a higher social support.
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1 year
|
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Family Strengths
Time Frame: 1 year
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It is developed by Olson, McCubbin, Barnes, Larsen, Muxen, & Wilson (1985).
There are 12 questions in the scale, and the items are: family self-esteem, family trust, family loyalty, family problem-solving ability, question options range from strongly agree to strongly disagree, the score range is from 12 to 60, the higher the score, the higher the family strength, the alpha reliability coefficients are .73
and .88,
Test-retest reliability was .73 and .79.
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1 year
|
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Self-Transcendence Scale
Time Frame: 1 year
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There are 15 questions, scored from 1 to 4. The higher the score, the higher the self-transcendence ability.
The Cronbach's alpha reliability coefficient of the tool is .70-.94 (Chen, 2009); the pretest Cronbach's alpha reliability coefficient of the Chinese version of the literature is.
79, and the post-test Cronbach's alpha reliability coefficient is .78
(Chen, 2009).
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1 year
|
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Family Adaptability and Cohesion Scale
Time Frame: 1 year
|
It is developed from Olson, et al, (1985), with a total of 30 questions.
The reliability of the instrument is .87
(cohesion) and .78
(adaptability) (Olson et al, 1985); the Chinese version of the document Cronbach's α>0.6 (Fei, 1991).The higher the score is, the higher the family adaptability and cohesionself-transcendence.
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1 year
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Parent-Adolescent Communication
Time Frame: 1 year
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It is developed from Olson, McCubbin, Barnes, Larsen, Muxen, & Wilson, (1985).
There are 30 questions, which can be divided into two subscales, with reliabilities of 0.87 and 0.78 respectively, using the confirmatory factor analysis (Olson et al. ,1985).
The Cronbach's alpha coefficient of the Chinese version of the father-child communication questionnaire is .76, the Cronbach's alpha coefficient of the mother-child communication questionnaire is .84(Chen,
2001).
Higher scores indicate better communication.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Linder LA, Hooke MC. Symptoms in Children Receiving Treatment for Cancer-Part II: Pain, Sadness, and Symptom Clusters. J Pediatr Oncol Nurs. 2019 Jul/Aug;36(4):262-279. doi: 10.1177/1043454219849578.
- Yu J, Dong H, Song Y, Zhu F. Influencing Factors of Hope Among Chinese Patients With Hematological Malignancies From the Perspective of Positive Psychology: A Cross-sectional Study. Cancer Nurs. 2022 Nov-Dec 01;45(6):465-472. doi: 10.1097/NCC.0000000000001035. Epub 2022 Jan 13.
- Yu J, Song H. Prevalence and risk factors of loneliness among patients with hematological malignancies. Medicine (Baltimore). 2022 Dec 2;101(48):e31900. doi: 10.1097/MD.0000000000031900.
- Borrescio-Higa F, Valdes N. The Psychosocial Burden of Families with Childhood Blood Cancer. Int J Environ Res Public Health. 2022 Jan 5;19(1):599. doi: 10.3390/ijerph19010599.
- Sharp K, Tillery R, Long A, Wang F, Pan H, Phipps S. Trajectories of resilience and posttraumatic stress in childhood cancer: Consistency of child and parent outcomes. Health Psychol. 2022 Apr;41(4):256-267. doi: 10.1037/hea0001132. Epub 2021 Dec 2.
- Rosales P, Evangelista L, Guo Y, Agbayani CG, Kain ZN, Fortier MA. Exploring Differences in Perceived Satisfaction, Resilience, and Achievement Between Hispanic and Non-Hispanic White Childhood Cancer Survivors. J Pediatr Health Care. 2021 Mar-Apr;35(2):196-204. doi: 10.1016/j.pedhc.2020.10.003. Epub 2021 Jan 28.
- Li Y, Ni N, Zhou Z, Dong J, Fu Y, Li J, Luan Z, Peng X. Hope and symptom burden of women with breast cancer undergoing chemotherapy: A cross-sectional study. J Clin Nurs. 2021 Aug;30(15-16):2293-2300. doi: 10.1111/jocn.15759. Epub 2021 Mar 23.
- Taylor EJ, Petersen C, Oyedele O, Haase J. Spirituality and Spiritual Care of Adolescents and Young Adults with Cancer. Semin Oncol Nurs. 2015 Aug;31(3):227-41. doi: 10.1016/j.soncn.2015.06.002. Epub 2015 Jun 6.
- Haase JE. The adolescent resilience model as a guide to interventions. J Pediatr Oncol Nurs. 2004 Sep-Oct;21(5):289-99; discussion 300-4. doi: 10.1177/1043454204267922.
- Decker C, Phillips CR, Haase JE. Information needs of adolescents with cancer. J Pediatr Oncol Nurs. 2004 Nov-Dec;21(6):327-34. doi: 10.1177/1043454204269606.
- Laksmita OD, Chung MH, Liao YM, Haase JE, Chang PC. Predictors of resilience among adolescent disaster survivors: A path analysis. J Adv Nurs. 2020 Aug;76(8):2060-2071. doi: 10.1111/jan.14396. Epub 2020 May 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2020
Primary Completion (Actual)
September 26, 2022
Study Completion (Actual)
September 26, 2022
Study Registration Dates
First Submitted
November 23, 2023
First Submitted That Met QC Criteria
December 12, 2023
First Posted (Actual)
December 22, 2023
Study Record Updates
Last Update Posted (Actual)
December 22, 2023
Last Update Submitted That Met QC Criteria
December 12, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- KMUHIRB-SV(I)-20200060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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