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

NCT06883877 | Not Yet Recruiting

• 1 other identifier: IIT2024-135-003
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief 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

Breast Cancer

Keywords

fear of cancer recurrence; symptoms; social support

Outcome Measures

Primary Outcomes (3)

• Fear of Cancer Recurrence Inventory-Short Form

  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

  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

  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

Study Arms (2)

Multi-Modal Program (MMP)

EXPERIMENTAL

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)

Routine care

OTHER

Other: Routine care

Interventions

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.

Multi-Modal Program (MMP)

Routine care OTHER

The control group will receive routine care.

Routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• LIU WEIMIN: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Weimin Liu, Phd

CONTACT

86+15810515761; liuweimin3158@bjsjth.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 19, 2025
• Study Start: June 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share