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Not yet recruiting NCT06883877

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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-Modal Program (MMP), Routine care.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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 intervent
  • Other Routine care
    The control group will receive routine care.

Primary outcome measures

  • Fear of Cancer Recurrence Inventory-Short Form [Time frame: 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]
  • The Chinese version of memorial symptom assessment scal [Time frame: baseline; 8 weeks post-intervention; 12 weeks post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06883877 · IIT2024-135-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗