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

LIU WEIMIN

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Other: Routine care; Other: Multi-Modal Program (MMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06883877

IIT2024-135-003

Details and patient eligibility

About

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).

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Multi-Modal Program (MMP)

Experimental group

Description:

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.

Treatment:

Other: Multi-Modal Program (MMP)

Routine care

Other group

Treatment:

Other: Routine care