NCT06559917

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 6, 2024

Last Update Submit

August 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Family Cohesion

    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 Outcomes (1)

  • Happiness

    Baseline and 1 week

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Experimental Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients in the experimental group and control group who reside in the same ward.
  • Patients who share a ward with subjects already included in the study.
  • Patients involved in ongoing medical disputes.
  • Patients who cannot understand the study explanation due to language or cognitive impairments.
  • Patients with a life expectancy shorter than the planned study duration.
  • Family members who do not have direct living or caregiving contact with the patient.
  • Family members who cannot visit the patient regularly or participate in the study.
  • Family members who cannot understand the study explanation due to language or cognitive impairments.
  • Family members with significant visual or hearing impairments who do not use assistive devices and cannot resolve communication issues.
  • Family members who cannot make independent decisions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yang WC, Li CY, Ho CL, Chang PY, Wu LF, Pan HH. Effectiveness of a Social Media-Based Life Review Intervention on Happiness in Advanced Cancer Patients and Their Family Caregivers: A Mixed-Methods Study. Psychooncology. 2026 Jan;35(1):e70374. doi: 10.1002/pon.70374.

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Graduate Student in Nursing

Study Record Dates

First Submitted

August 6, 2024

First Posted

August 19, 2024

Study Start

September 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share