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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Taiwan
      • Kaohsiung, Taiwan, 80361
        • Kaohsiung Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Adolescence and Youth with cancer
Participants were diagnosed with cancer before 18 years old and aged between 10 and 24 years

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
1 year
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.
1 year
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.
1 year
Spiritual Perspective Scale (SPS)
Time Frame: 1 year
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).
1 year
Perceived Social Support (PSS)
Time Frame: 1 year
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
Family Strengths
Time Frame: 1 year
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
Self-Transcendence Scale
Time Frame: 1 year
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
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.
1 year
Parent-Adolescent Communication
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University Chung-Ho Memorial Hospital

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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