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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06179914
Other study ID # KMUHIRB-SV(I)-20200060
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2, 2020
Est. completion date September 26, 2022

Study information

Verified date November 2023
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Validation of Resilience Models about Cancer in Adolescence and Youth in Taiwan


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.


Recruitment information / eligibility

Status Completed
Enrollment 223
Est. completion date September 26, 2022
Est. primary completion date September 26, 2022
Accepts healthy volunteers No
Gender All
Age group 10 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Kaohsiung Medical University Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):1 — View Citation

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. — View Citation

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. — View Citation

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.000000000000 — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Herth Hope Index (HHI) 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. 1 year
Primary Resilience in Illness Scale (HARS) 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. 1 year
Secondary Symptom Distress Scale (SDS) 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 a =.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. 1 year
Secondary mishel Uncertainty in Illness Scale - Revised 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 a =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. 1 year
Secondary Jalowiec Coping Scale-Revised 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 a=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. 1 year
Secondary Spiritual Perspective Scale (SPS) 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 a=0.78 and the subscale is 0.84 (question solution), 0.83 (defensive behavior) (Jalowiec et al, 1984). 1 year
Secondary Perceived Social Support (PSS) 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. 1 year
Secondary Family Strengths 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. 1 year
Secondary Self-Transcendence Scale 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). 1 year
Secondary Family Adaptability and Cohesion Scale 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 a>0.6 (Fei, 1991).The higher the score is, the higher the family adaptability and cohesionself-transcendence. 1 year
Secondary Parent-Adolescent Communication 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. 1 year
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