A cancer rehabilitation and lymphedema care program for patients with resected advanced head and neck cancer

A cancer rehabilitation and lymphedema care program for patients with resected advanced head and neck cancer: the prevalence and risk factors for head and neck cancer-related lymphedema and development and testing of an intervention and longitudinal measures of its functional outcomes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16929593

Enrollment

Registered

2017-10-18

Start date

2017-08-01

Completion date

Unknown

Last updated

2021-06-28

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

Conditions

Head and neck cancer Cancer

Interventions

Eligible participants will be recruited three months after the completion of treatment and randomized by casting lots for odd or even numbers (even-control, odd-experimental) into a control group (who

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologic confirmation of advanced HNSCC (stage III or IV) and patient awareness of the diagnosis 2. Receipt of radical surgery and RT or CCRT 3. Completion of radical surgery and RT or CCRT from 3 months to 5 years in the past 4. Have HNCRL based on physical examination (Foldi’s Scale score > stage I) 5. Currently free of evidence of cancer 6. Age greater than 20 years and less than 70 years 7. Karnofsky’s Performance Status Index (KPS) score of 60 or greater 8. Agreement to participate in the study after explanation of its purposes and procedures

Exclusion criteria

Exclusion criteria: 1. Unresected head and neck cancer 2. Actively undergoing chemotherapy or RT 3. Having metastatic cancer or any other active cancer 4. Any unstable systemic disease (heart disease, active infection, or other underlying disease) 5. KPS score of 60 or less 6. Any condition likely to cause discomfort during the research interview

Design outcomes

Primary

Measure	Time frame
Functional outcomes measured by the Brief International Classification of Functioning, Disability and Health (ICF) Core Set for Head and Neck Cancer (BCSQ-H&N) at four time points: baseline (before the CRLCP) (T0) and 1, 3, and 6 months after first participating in the CRLCP (T1, T2, and T3, respectively)	—

Secondary

Measure	Time frame
Measured at four time points: baseline (before the CRLCP) (T0) and 1, 3, and 6 months after first participating in the CRLCP (T1, T2, and T3, respectively): 1. Symptom distress measured by the Symptom Distress Scale–Modified for Head and Neck Cancer (SDS-mhnc) 2. Body image measured by the Body Image Scale–Modified (BIS-m) 3. Stage of lymphedema measured by the MD Anderson Head and Neck Lymphedema Rating Scale (MDAHNLRS) 4. Shoulder motion measured by the UCLA Shoulder Rating Scale (UCLA SRS) 5. Physical performance measured by the Karnofsky Performance Status Index (KPS)	—

Measure

Time frame

Measured at four time points: baseline (before the CRLCP) (T0) and 1, 3, and 6 months after first participating in the CRLCP (T1, T2, and T3, respectively): 1. Symptom distress measured by the Symptom Distress Scale–Modified for Head and Neck Cancer (SDS-mhnc) 2. Body image measured by the Body Image Scale–Modified (BIS-m) 3. Stage of lymphedema measured by the MD Anderson Head and Neck Lymphedema Rating Scale (MDAHNLRS) 4. Shoulder motion measured by the UCLA Shoulder Rating Scale (UCLA SRS) 5. Physical performance measured by the Karnofsky Performance Status Index (KPS)

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Countries

Taiwan

Outcome results

None listed

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