Breast Cancer
Conditions
Keywords
fear of cancer recurrence, symptoms, social support
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).
Interventions
OTHERMulti-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.
OTHERRoutine care
The control group will receive routine care.
Sponsors
LIU WEIMIN
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fear of Cancer Recurrence Inventory-Short Form | 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 | 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 | 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. |
Contacts
Primary ContactWeimin Liu, Phd
Outcome results
None listed