The Effect of a Multi-modal Program on Fear of Cancer Recurrence in Breast Cancer Patients

NCT06883877 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-03-19

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if MMP intervention can alleviate FCR , breast cancer symptoms and social support among breast cancer patients. he main questions it aims to answer are:

* Null Hypotheses (H0): There is no significant difference in FCR, breast cancer symptoms, and social support between the MMP intervention group and the control group.
* Alternative Hypotheses (H1): There are significant differences in FCR, breast cancer symptoms, and social support between the MMP intervention group and the control group

Researchers will compare MMP to a routine care to see if MMP works to alleviate FCR, breast cancer symptoms and social support.

Participants will:

* Receive interventions once per chemotherapy cycle for 8 weeks.
* The FCRI-SF, MSAS-SF-SC, and SSRS scales will be utilized to assess FCR levels, breast cancer symptoms and social support in both the experimental and control groups, with measurements conducted at baseline (T1), 8 weeks post-intervention (T2), and 12 weeks post-intervention (T3).

Conditions

Interventions

OTHER

Multi-Modal Program (MMP)

MMP includes three modules: addressing psychological problems such as FCR; addressing problems related to breast cancer symptoms; and addressing tangible problems such as social support. Each module is divided into the chemotherapy period (hospitalization) and the chemotherapy interval (post-discharge). Each phase involves face-to-face, digital, and remote tools, with the intervention lasting 8 weeks. Each module has a different goal, and depending on the goal setting, the topic of the intervention is different. The goal of the information education stage is to improve patients' overall understanding of the disease and pay attention to the psychological problems of FCR. The goal of coping skills is that through the practice of coping skills, patients can learn to change thoughts, problem emotions, and behaviors. The objective of social support group interaction is to strengthen their social support networks.

OTHER

Routine care

The control group will receive routine care.

Sponsors & Collaborators

  • LIU WEIMIN

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-11-30
Completion
2025-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06883877 on ClinicalTrials.gov