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Development and Preliminary Application of a Family Adaptive Intervention Protocol Based on the FAAR Model for Breast Cancer-Related Lymphedema

Development and Preliminary Application of a Family Adaptive Intervention Protocol Based on the FAAR Model for Breast Cancer-Related Lymphedema

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114852
Enrollment
Unknown
Registered
2025-12-18
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer-related lymphedema

Interventions

Control group:Routine health education
Intervention group:Family adaptive intervention program
BCRL Patient Family Interview Group:None

Sponsors

Jiangsu Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. (Qualitative) Patients: (1) Clinically diagnosed with breast cancer-related secondary lymphedema; (2) Aged 18 or older, capable of expressing themselves independently; (3) Normal language abilities, able to cooperate with interviews, and willing to sign informed consent; (4) Received comprehensive decongestive therapy within the past year. 2. Family members: (1) Aged 18 or older, without severe visual or hearing impairments; (2) Living with the patient for a long period; (3) Fully understand the study and voluntarily agree to participate. 3. (Intervention) Patients: (1) Clinically diagnosed with breast cancer-related secondary lymphedema and currently receiving comprehensive swelling reduction treatment; (2) Aged 18 or above, with at least primary school education and basic reading ability; (3) Able to cooperate with questionnaire completion and intervention measures, and voluntarily sign the informed consent form; (4) Able to use a smartphone and WeChat. 4. Primary family caregivers: (1) Aged 18 or above, without severe visual or hearing impairments; (2) Have substantial decision-making participation in family health management; (3) Able to read and proficiently use a smartphone; (4) Fully understand the study content and voluntarily participate.

Exclusion criteria

Exclusion criteria: 1. (Qualitative) Patients: (1) Living alone or without primary caregiver support; (2) With severe comorbidities, such as heart, liver, kidney dysfunction, or other malignancies; (3) Experiencing edema due to malnutrition, heart or kidney dysfunction, etc.; (4) History of surgery on the affected limb within the past year; (5) Having cognitive impairment or mental illness; (6) Expected survival less than 6 months; (7) Participating in other intervention studies on the same topic concurrently. 2. Family members: (1) Health professionals in related fields; (2) Suffering from major illnesses, such as malignancies or severe mental disorders. 3. (Intervention) Patients: (1) With other malignant tumors or severe dysfunction of the heart, liver, or kidneys; (2) Severe cognitive impairment or mental illness; (3) Concurrent participation in other intervention studies; (4) Living alone or without primary caregiver support; (5) History of other surgeries on the affected limb within the past year. 4. Primary family caregivers: (1) Professional medical personnel in the relevant field; (2) Suffering from major diseases themselves; (3) Planning to be away for an extended period in the next 3 months.

Design outcomes

Primary

MeasureTime frame
Family adaptation of BCRL patients;

Secondary

MeasureTime frame
Self-management compliance of BCRL patients;The quality of life of BCRL patients;

Countries

China

Contacts

Public ContactCheng Fang

Jiangsu Cancer Hospital

chfnancy@163.com+86 153 8088 2642

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026