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Childhood CancerNCT06179914

Resilience Models in Adolescence and Youth With Cancer in Taiwan

An observational study of Childhood Cancer and Coping Behavior, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Validation of Resilience Models about Cancer in Adolescence and Youth in Taiwan Read more about this study

Who is it for?
Ages 10 to 24 years
Conditions the study is for
Childhood Cancer, Coping Behavior, Hope
How many people
223 participants
Where
1 siteTaiwan
Study dates
2 Nov 2020to 26 Sep 2022
How long will I take part?
1 Day
Phase
Observational
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 10 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: childhood cancer at age between 10 and 24

Who may be able to join

  • Diagnosed with cancer before 18 years old
  • Aged between 10 and 24 years
  • Received cancer treatment or completed treatment

Who cannot join

  • Diagnosis of mental problems (developmental delay or psychiatric illness)
  • At the end of life

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Medical University

    Kaohsiung City, 80361

Other trials in Taiwan

About this study

Official title: Validation of Resilience Models About Cancer in Adolescence and Youth in Taiwan

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

Read the 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.

Keywords
Resilience, Hope, social support, Coping, adolescent and young adult, uncertainty
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06179914
Study groupRoleWhat they receive
Adolescence and Youth with cancerParticipants were diagnosed with cancer before 18 years old and aged between 10 and 24 years

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

Secondary outcomes (9)

  1. 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 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.

    Measured: 1 year

  2. 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 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.

    Measured: 1 year

  3. 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 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.

    Measured: 1 year

  4. 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 α=0.78 and the subscale is 0.84 (question solution), 0.83 (defensive behavior) (Jalowiec et al, 1984).

    Measured: 1 year

  5. 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.

    Measured: 1 year

  6. 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.

    Measured: 1 year

  7. 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).

    Measured: 1 year

  8. 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 α>0.6 (Fei, 1991).The higher the score is, the higher the family adaptability and cohesionself-transcendence.

    Measured: 1 year

  9. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2023
  2. Study start2 Nov 2020
  3. Primary completion26 Sep 2022
  4. Study completion26 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
223 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06179914
Sponsor's protocol ID
KMUHIRB-SV(I)-20200060
Status last verified
Nov 2023
First submitted
23 Nov 2023
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35025774

  • 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.

    PubMed 36482642

  • 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.

    PubMed 35010854

  • 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.

    PubMed 31307323

  • 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.

    PubMed 34855418

  • 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.

    PubMed 33516620

  • 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.

    PubMed 33756013

  • 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.

    PubMed 26210201

  • 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.

    PubMed 15381798

  • 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.

    PubMed 15475469

  • 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.

    PubMed 32301129

Questions about this trial

What is this clinical trial studying?

An observational study of Childhood Cancer and Coping Behavior, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

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 2 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 22 Dec 2023. 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 Taiwan. 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?

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?

Herth Hope Index (HHI) (time frame: 1 year). The study lists 2 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 NCT06179914, which also lists 11 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 22 Dec 2023.

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