Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Breast Cancer Treatment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Change in Breast Edema Questionnaire (BrEQ) score
研究概览
简要总结
The goal of the KiTaLymph trial is to investigate whether the application of kinesio tape is effective in women with persistent (>6 months) breast and/or truncal oedema after treatment for breast cancer.
The main objectives are to assess whether kinesio taping:
- reduces pain and symptoms,
- decreases swelling,
- improves quality of life (QoL).
This study will compare a control group receiving standard care, decongestive lymphatic therapy (DLT), to an intervention group receiving DLT in combination with kinesio taping, in order to determine whether the addition of kinesio tape yields superior clinical outcomes.
Participants will be randomly allocated to one of the two study arms. Both groups will participate in a 4-week intervention phase, consisting of two treatment sessions per week. This will be followed by a 6-month follow-up period to assess the durability of treatment effects and cost-related outcomes.
A total of approximately 128 participants will be recruited. Outcome assessments will be conducted at baseline, immediately post-intervention (1 month), and at 3 and 6 months following the end of the intervention. These assessments will include standardised patient-reported outcome measures evaluating symptoms, quality of life, and pain, namely, the Breast Edema Questionnaire (BrEQ), the EORTC-QLQ-BR23, the EQ-5D-5L, and a visual analogue scale (VAS), as well as objective physical measurements of oedema using the LymphScanner (expressed as percentage water content, PWC).
In addition to the primary research objective, several sub-studies will be conducted. These will include: (1) a longitudinal analysis of the effects of standard treatment; (2) an evaluation of the responsiveness and clinical utility of the BrEQ; and (3) a cross-sectional analysis of the compression pressure exerted by various compression bras. All sub-studies are methodologically feasible within the projected sample size of the primary objective and aim to provide supplementary insights into the clinical management of breast and truncal oedema.
详细描述
As outlined in the brief summary, three sub-studies will be embedded within the main study sample. The following section provides a concise overview of the methodological approach for each of these sub-studies.
- The longitudinal effect of decongestive lymphatic therapy:
This sub-study examines the (long-term) effect of DLT on symptoms and functioning in women with persistent breast and/or truncal oedema following breast cancer treatment. The analysis will focus on participants in the control group, who receive DLT alone. Outcomes such as symptom burden (BrEQ), local tissue water (PWC), pain (VAS), and quality of life (EQ-5D-5L and EORTC-QLQ-BR23) will be tracked at multiple time points: baseline, after 1 month of intervention, and 3 and 6 months after the end of the intervention.
No additional intervention is introduced beyond the standard treatment already described in the main study protocol. The sub-study will assess the sustainability of symptom improvement over time and provide insight into the standalone effectiveness of DLT. 2. Responsiveness of the Breast Edema Questionnaire:
This sub-study aims to evaluate the responsiveness of the BrEQ, a validated questionnaire used to assess symptoms related to breast oedema. Although the BrEQ has demonstrated strong psychometric properties, its ability to detect clinically meaningful changes over time has not yet been investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients previously treated for breast cancer.
- •Suffering from persistent (>6 months) breast and/or truncal oedema, established at least six months after completion of radiotherapy.
- •Objective measurements:
- •BrEQ score ≥
- •PWC (LymphScanner) showing at least one of the following:
- •Truncal oedema: ratio ≥ 1.
- •Breast oedema: ratio ≥ 1.
- •Local PWC of 52.90%.
- •Clinical evaluation:
- •At least one positive sign of breast and/or truncal oedema such as:
- •Visual swelling compared with the contralateral side.
- •Visible imprint of the bra on the skin.
- •Peau d'orange appearance on the breast.
排除标准
- •Presence of skin infections or wounds of the breast/truncal region at the time of inclusion making it impossible to apply kinesio tape.
- •Age under 18 years.
- •Not able to read and understand Dutch language.
- •Having received mastectomy.
- •Metastatic breast cancer.
研究组 & 干预措施
Control group (standard treatment)
Participants receive standard DLT, as described in the intervention section, consisting of two sessions per week over four weeks. Self-care activities are continued between sessions and recorded in a self-care diary.
干预措施: Compression bra (sub-study) (Other)
Control group (standard treatment)
Participants receive standard DLT, as described in the intervention section, consisting of two sessions per week over four weeks. Self-care activities are continued between sessions and recorded in a self-care diary.
干预措施: Decongestive lymphatic therapy (Other)
Intervention group
Participants receive standard DLT, as described in the intervention section, delivered two times per week over four weeks. In addition, kinesio tape is applied to the affected area by a trained physiotherapist following a standardized protocol. Participants may continue kinesio tape use independently during the follow-up period. A kinesio tape diary is used to record kinesio tape usage.
干预措施: Decongestive lymphatic therapy (Other)
Intervention group
Participants receive standard DLT, as described in the intervention section, delivered two times per week over four weeks. In addition, kinesio tape is applied to the affected area by a trained physiotherapist following a standardized protocol. Participants may continue kinesio tape use independently during the follow-up period. A kinesio tape diary is used to record kinesio tape usage.
干预措施: Kinesio tape (Other)
Intervention group
Participants receive standard DLT, as described in the intervention section, delivered two times per week over four weeks. In addition, kinesio tape is applied to the affected area by a trained physiotherapist following a standardized protocol. Participants may continue kinesio tape use independently during the follow-up period. A kinesio tape diary is used to record kinesio tape usage.
干预措施: Compression bra (sub-study) (Other)
结局指标
主要结局
Change in Breast Edema Questionnaire (BrEQ) score
时间窗: From baseline to the end of one month of treatment
The Breast Edema Questionnaire (BrEQ) is a validated Dutch patient-reported outcome measure designed to assess the impact of breast oedema. Part 1 of the BrEQ evaluates eight symptoms: pain, heaviness, swelling, tensed skin, redness, pitting sign, enlarged skin pores, and hardness. Each symptom is scored on an 11-point Likert scale ranging from 0 ("not at all") to 10 ("very severe"), resulting in a total symptom score ranging from 0 to 80. Higher scores indicate greater severity of breast oedema symptoms. A total score of ≥9 has been identified as the optimal cut-off point to discriminate between patients with and without breast oedema. The primary comparison will assess group differences in BrEQ score after one month of treatment.
Change in Breast Edema Questionnaire (BrEQ) score
时间窗: From baseline to the end of one month of treatment
The Breast Edema Questionnaire (BrEQ) is a validated Dutch patient-reported outcome measure designed to assess the impact of breast oedema. Part 1 of the BrEQ evaluates eight symptoms: pain, heaviness, swelling, tensed skin, redness, pitting sign, enlarged skin pores, and hardness. Each symptom is scored on an 11-point Likert scale ranging from 0 ("not at all") to 10 ("very severe"), resulting in a total symptom score ranging from 0 to 80. Higher scores indicate greater severity of breast oedema symptoms. A total score of ≥9 has been identified as the optimal cut-off point to discriminate between patients with and without breast oedema. The primary comparison will assess group differences in BrEQ score after one month of treatment.
次要结局
- Documentation of self-reported standard care practices using a self-care diary during the intervention and follow-up periods.(From enrollment to the end of the study at 7 months.)
- Feasibility and self-reported use of kinesio tape during follow-up as documented in a diary (intervention group only).(From the end of the 4-week intervention period to the 6-month follow-up measurement.)
- Change in Breast Edema Questionnaire (BrEQ) score at 3 and 6 months post end of treatment.(From the end of the 4-week intervention period to the 6-months follow-up measurements.)
- Responsiveness of the BrEQ (substudy)(From baseline to one month of intervention (intensive group); and 3 and 4 months post-intervention (maintenance group).)
- Pressure under compression bras (substudy)(First day of wearing the compression bra.)
- Comfort of a compression bra (substudy)(After one week of wearing the specific compression bra.)
- Change in local tissue water (PWC)(From baseline to the end of the treatment period (1 month), and 3 and 6 months after the end of the treatment.)
- Change in pain intensity (VAS).(From baseline to the end of the treatment period (1 month), and 3 and 6 months after the end of the treatment.)
- Change in quality of life (EORTC-QLQ-BR23).(From baseline to the end of the treatment period (1 month), and 3 and 6 months after the end of the treatment.)
- Change in quality of life (EQ-5D-5L)(From baseline to the end of the treatment period (1 month), and 3 and 6 months after the end of the treatment.)
- Documentation of self-reported standard care practices using a self-care diary during the intervention and follow-up periods.(From enrollment to the end of the study at 7 months.)
- Feasibility and self-reported use of kinesio tape during follow-up as documented in a diary (intervention group only).(From the end of the 4-week intervention period to the 6-month follow-up measurement.)
- Change in Breast Edema Questionnaire (BrEQ) score at 3 and 6 months post end of treatment.(From the end of the 4-week intervention period to the 6-months follow-up measurements.)
- Responsiveness of the BrEQ (substudy)(From baseline to one month of intervention (intensive group); and 3 and 4 months post-intervention (maintenance group).)
- Pressure under compression bras (substudy)(First day of wearing the compression bra.)
- Comfort of a compression bra (substudy)(After one week of wearing the specific compression bra.)
研究者
Nick Gebruers
Associate Professor
Universiteit Antwerpen