Effectiveness on Family Cohesion and Happiness of Using Social Media to Enhance Happiness Accounts for Late-Stage Cancer Patients and Their Families

August 14, 2024 updated by: YANG WEN-CHI
The study period is from September 1, 2024, to December 31, 2025. The subjects are cancer patients from the medical center of this hospital. A block randomization will be used to assign 100 patients to the experimental group and 100 patients to the control group, totaling 200 patients. During the study process, questionnaires and medical records of the subjects will be collected. The experimental group will receive the social media "Happiness Ledger" intervention, while the control group will receive routine treatment. Questionnaires will be collected from both groups before and after the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
Interventional

Enrollment (Estimated)

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.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

-

Inclusion Criteria for Advanced Cancer Patients:

  1. Patients diagnosed with stage III or IV cancer by a specialist physician.
  2. Patients who agree to participate in the study after being informed about the research.
  3. Patients who are conscious and able to communicate in Mandarin or Taiwanese.
  4. Patients aged 20 years or older.
  5. Patients with no history of mental illness.

Inclusion Criteria for Family Members:

  1. The primary caregiver of a patient diagnosed with stage III or IV cancer by a specialist physician.
  2. The primary caregiver who has a blood, marital, or cohabitation relationship with the patient.
  3. Family members who agree to participate in the study after being informed about the research.
  4. Family members who are conscious and able to communicate in Mandarin or Taiwanese.
  5. Family members aged 20 years or older.
  6. Family members with no history of mental illness.

Exclusion Criteria:

-

Exclusion Criteria for Advanced Cancer Patients:

  1. Patients in the experimental group and control group who reside in the same ward.
  2. Patients who share a ward with subjects already included in the study.
  3. Patients involved in ongoing medical disputes.
  4. Patients who cannot understand the study explanation due to language or cognitive impairments.
  5. Patients with a life expectancy shorter than the planned study duration.

Exclusion Criteria for Family Members:

  1. Family members who do not have direct living or caregiving contact with the patient.
  2. Family members who cannot visit the patient regularly or participate in the study.
  3. Family members who cannot understand the study explanation due to language or cognitive impairments.
  4. Family members with significant visual or hearing impairments who do not use assistive devices and cannot resolve communication issues.
  5. Family members who cannot make independent decisions.

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Upon admission to the cancer-related ward, after explaining the purpose and process of the study, patients who agree to participate in the study will complete the first questionnaire before the intervention with the social media "Happiness Ledger". The family members will have one week to organize photos, after which the patients will share the meaning of the photos. The process will be recorded by the researcher and will last approximately 40 to 60 minutes. Afterward, the researcher will create a video of about three minutes using the photos and ask the participating family members to assist in uploading the photos to the family LINE group as feedback to the research subjects. The patients will then complete the second questionnaire.
Other: life review
After consenting, they will complete the first questionnaire before receiving the "Happiness Ledger" intervention via social media. Family members will have one week to organize photos, after which patients will share the meaning of the photos. This process will be recorded by the researcher and will last approximately 40 to 60 minutes. The researcher will then create a three-minute video using the photos, and the participating family members will assist in uploading the photos to the family LINE group as feedback to the subjects. The second questionnaire will then be completed.
No Intervention: Control Group
After explaining the purpose and process of the study to the patients and their family members on the day of admission, and obtaining their consent to participate in the study, they will complete the first questionnaire. One week later, they will complete the second questionnaire. After the entire study is completed, the control group will receive the same social media "Happiness Ledger" intervention as the experimental group. Data collection will be conducted for both groups before and after the intervention.

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
Family Cohesion
Time Frame: Baseline (pre-intervention) and 1 week after intervention
This study uses the Family Adaptability and Cohesion Evaluation Scale (FACES II) developed by Olson et al. (1979), which consists of 30 items to measure the family cohesion of patients and their families .
Baseline (pre-intervention) and 1 week after intervention

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
Happiness
Time Frame: Baseline and 1 week
This study uses the Subjective Happiness Scale (SHS) created by Lyubomirsky & Lepper (1999), which consists of 4 items to measure the happiness of patients and their families."
Baseline and 1 week

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.
YANG WEN-CHI

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 (Estimated)

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.
September 1, 2024

Primary Completion (Estimated)

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.
December 31, 2024

Study Completion (Estimated)

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.
December 31, 2025

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).
August 6, 2024

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.
August 14, 2024

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.
August 19, 2024

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.
August 19, 2024

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.
August 14, 2024

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.
August 1, 2024

More Information

Terms related to this study

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.
  • A202405117

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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