The Effect of a Multi-modal Program on Fear of Cancer Recurrence 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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-Modal Program (MMP)

Other

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.

Routine care

Other

The control group will receive routine care.

Primary outcomes

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
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.
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Weimin Liu, Phd

CONTACT

[email protected]

86+15810515761

Sponsors and collaborators

Lead sponsor

LIU WEIMIN

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 19, 2025
Registry last updated: Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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