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

March 16, 2025 updated by: LIU WEIMIN

The Effect of a Multi-modal Program on Fear of Cancer Recurrence, Breast Cancer Symptoms and Social Support in Breast Cancer Patients

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis meets the criteria outlined in the Breast Cancer Diagnosis and Treatment Guidelines, with a pathological diagnosis of breast cancer and currently undergoing chemotherapy
  • Age ≥ 18 years
  • Clear consciousness and the ability to communicate independently
  • Aware of the diagnosis and has signed the informed consent form

Exclusion Criteria:

  • Presence of mental illness or cognitive impairment
  • Hearing or speech impairmen
  • Distant metastasis of cance
  • Severe physical illness or other malignant tumors requiring treatment

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Routine care
Other: Routine care
The control group will receive routine care.
Experimental: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of Cancer Recurrence Inventory-Short Form
Time Frame: baseline; 8 weeks post-intervention; 12 weeks post-intervention
It consists of nine items, each of which is assessed using a 5-point Likert scale ranging from 0 to 4. The total score ranges from 0-36, with elevated scores reflecting heightened FCR
baseline; 8 weeks post-intervention; 12 weeks post-intervention
The Social Support Rating Scale
Time Frame: baseline; 8 weeks post-intervention; 12 weeks post-intervention
This instrument comprises 10 items categorized into three dimensions, yielding a total score between 0 and 66, where elevated scores denote greater social support.
baseline; 8 weeks post-intervention; 12 weeks post-intervention
The Chinese version of memorial symptom assessment scal
Time Frame: baseline; 8 weeks post-intervention; 12 weeks post-intervention
The scoring range for physical symptoms is from 0-4, whereas other items are scored from 1-4. Higher scores indicate greater distress.
baseline; 8 weeks post-intervention; 12 weeks post-intervention

Collaborators and Investigators

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

Sponsor

LIU WEIMIN

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)

June 1, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

March 9, 2025

First Submitted That Met QC Criteria

March 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 16, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2024-135-003

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

product manufactured in and exported from the U.S.

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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