Evaluation of Adherence to Rehabilitation: Autonomous and Guided, in the Observation and Treatment Response of Head and Neck Lymphedema in Neoplasms During Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 主要终点
- Proportion of Participants With Treatment Adherence Rate ≥80% During the Radiotherapy Period
研究概览
简要总结
Head and neck lymphedema is a common complication after treatment for head and neck cancer. It can cause swelling of the face and neck, discomfort, reduced neck and jaw mobility, swallowing difficulties, and a negative impact on quality of life. One usual treatment approach includes manual lymphatic drainage, exercises, skin care, and the use of a compression garment worn for several hours each day. However, wearing a compression garment for a long period may be difficult for patients because of discomfort, appearance, social constraints, or practical limitations, which may reduce adherence to treatment.
The ARAGORN study aims to determine whether a more autonomous rehabilitation program, based on patient education, self-drainage, targeted exercises, and short-duration compression bandaging performed twice daily, leads to better treatment adherence than the usual recommended approach using prolonged compression garment wear.
The main question of the study is whether patients receiving the autonomous, guided rehabilitation program are more likely to adhere to their prescribed lymphedema treatment over the radiotherapy period than patients receiving the usual recommended care. The study hypothesis is that a patient-centered, self-management approach may improve adherence by making treatment easier to integrate into daily life, while maintaining potential benefits on swelling, symptoms, function, and quality of life.
详细描述
ARAGORN is a prospective, single-center, randomized controlled trial evaluating two rehabilitation strategies for external head and neck lymphedema in patients treated with adjuvant radiotherapy for head and neck cancer. Participants are randomized in a 1:1 ratio to either the usual recommended rehabilitation approach or an autonomous, guided self-management rehabilitation program.
The rationale for the study is that external head and neck lymphedema is frequent after head and neck cancer treatment and may be associated with pain, cosmetic and functional discomfort, reduced cervical or mandibular mobility, swallowing difficulties, and impaired quality of life. Although combined decongestive therapy is commonly recommended, adherence to prolonged compression garment wear is often limited in clinical practice. A shorter, structured, patient-performed bandaging approach combined with self-drainage and exercises may represent a more acceptable strategy for patients.
Participants allocated to the usual recommended care group receive combined decongestive therapy, including manual lymphatic drainage performed by a physiotherapist, daily cervico-facial and scapular exercises, skin care, and use of an adapted compression garment for at least 8 hours per day.
Participants allocated to the autonomous guided rehabilitation group receive education and supervised training in self-lymphatic drainage, short-duration multilayer self-bandaging, targeted cervico-facial and mandibular exercises, daily cervico-facial and scapular exercises, and skin care. The self-bandaging program is performed twice daily, with each session lasting approximately 1 hour, in association with active exercises. The intervention is designed to support patient autonomy while maintaining safety through initial education and regular follow-up.
The planned sample size is 56 participants, with 28 participants in each group. Each participant is followed during the radiotherapy treatment period, approximately 7 weeks. The total planned duration of the study is approximately 26 months, including recruitment and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Only the outcomes assessor is masked to treatment allocation. Weekly adherence assessment is performed by a physiotherapist who is distinct from the therapist delivering the intervention and patient education. The masked assessor does not have access to the randomization list or to the content of treatment sessions. Patient self-monitoring materials and photographs used for assessment are prepared to avoid revealing the assigned intervention whenever possible. Participants are instructed not to disclose their assigned treatment to the assessor. Any accidental unmasking is documented in the case report form.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Histologically confirmed diagnosis of head and neck cancer
- •Postoperative status after surgical resection
- •Currently receiving adjuvant radiotherapy
- •No evidence of local tumor progression
- •Presence of head and neck lymphedema
- •Able to apply and remove the compression device independently or with the help of a caregiver
- •Clinically stable condition with no contraindication to lymphatic drainage or compression therapy
- •Affiliated with a social security system or beneficiary of such a system. Able to understand the study instructions
- •Able to follow the study procedures
- •Able to provide written informed consent
排除标准
- •Confirmed or suspected active tumor
- •Confirmed or suspected local tumor recurrence
- •Medical contraindication to combined decongestive therapy
- •Acute dermatitis
- •Local infection
- •Open wound
- •Ongoing thrombosis
- •Documented primary lymphatic disease, such as congenital lymphedema
- •Cognitive impairment preventing understanding of the study protocol
- •Language barrier preventing understanding of the study protocol
- •Psychiatric condition preventing understanding of the study protocol
- •Person under legal protection guardianship or curatorship
- •Patient with a limitation-of-care decision.
研究组 & 干预措施
Usual recommended care
Participants assigned to this arm receive the usual recommended rehabilitation care for external head and neck lymphedema. This includes manual lymphatic drainage performed by a physiotherapist, daily cervico-facial and scapular exercises, skin care including skin monitoring and prevention of radiodermatitis, and use of an adapted compression garment for at least 8 hours per day, continuously or intermittently, with adherence monitoring.
干预措施: Usual recommended care (Other)
Autonomous Guided Rehabilitation Program
Participants assigned to this arm receive an autonomous, guided rehabilitation program for external head and neck lymphedema. The program includes supervised education in self-manual lymphatic drainage, self-application of short-duration multilayer compression bandaging, targeted cervico-facial and mandibular exercises, daily cervico-facial and scapular exercises, and skin care. Self-bandaging is performed twice daily for approximately 1 hour per session and is associated with active exercises.
干预措施: Autonomous Guided Rehabilitation Program (Other)
结局指标
主要结局
Proportion of Participants With Treatment Adherence Rate ≥80% During the Radiotherapy Period
时间窗: From start of assigned rehabilitation to the end of radiotherapy, approximately 7 weeks
Treatment adherence is defined for each participant as the percentage of days on which the prescribed lymphedema management modality is performed according to the protocol, divided by the total number of expected treatment days. Participants are classified as adherent if their individual adherence rate is ≥80% over the full treatment period and non-adherent if their adherence rate is \<80%. Adherence is collected using a daily self-monitoring diary and checked during weekly follow-up visits.
次要结局
- Number of participants with adverse events related to lymphedema management as assessed by the common terminology criteria for adverse events(From start of assigned rehabilitation to the end of radiotherapy, approximately 7 weeks)
- Global Rating of Change Score During the Radiotherapy Period(Weekly from the first follow-up visit to the end of radiotherapy, approximately 7 weeks)
- Change from baseline in external head and neck lymphedema measurements at the end of radiotherapy(Baseline and end of radiotherapy, approximately 7 weeks)
- Change from baseline in clinical stage of external Head and Neck Lymphedema according to the Földi Scale at the end of radiotherapy(Baseline and end of radiotherapy, approximately 7 weeks)
- Change from baseline in pain visual analog scale score at the end of rariotherapy(Baseline and end of radiotherapy, approximately 7 weeks)
- Change from baseline in cervical range of motion measured by CROM at the end of radiotherapy(Baseline and end of radiotherapy, approximately 7 weeks)
- Change from baseline in eating assessment tool-10 score at the end of radiotherapy(Baseline and end of radiotherapy, approximately 7 weeks)
- Change from baseline in maximum mouth opening at the end of radiotherapy(Baseline and end of radiotherapy, approximately 7 weeks)
- Change from baseline in EORTC QLQ-H&N35 score at the end of radiotherapy(Baseline and end of radiotherapy, approximately 7 weeks)