Rosen Jennifer, Lawrence Rebecca, Bouchard Michele, Doros Gheorghe, Gardiner Paula, Saper Robert
Adv Mind Body Med. 2013 Winter;27(1):12-23.
Despite major advances in cancer treatment, many patients undergo painful procedures during treatment and suffer debilitating side effects as well as report a decrease in quality of life (QOL). This problem is exacerbated for low-income, racial, and ethnic minorities with cancer. Minority cancer patients often enter care with larger tumors and with a more aggressive disease, increasing the risk of debilitating symptoms, such as pain and anxiety. Researchers have never assessed the feasibility and effectiveness of offering massage therapy for low-income, underserved cancer patients who are undergoing port insertion.
This study examined the feasibility of conducting a randomized, controlled trial (RCT) that would assess the use of massage therapy to reduce pain and anxiety in urban patients with cancer who undergo surgical placement of a vascular access device (port). The study also assessed the effectiveness of the intervention in reducing perioperative pain and anxiety.
The research team conducted a 9-month RC T of 60 cancer patients undergoing port placement. The research team randomly assigned patients in a 2:1 ratio to usual care with massage therapy (intervention group) versus usual care with structured attention (control group).
The study took place at Boston Medical Center (BMC), which is an urban, tertiary-referral, safety-net hospital.
Participants were cancer patients undergoing port placement. Sixty-seven percent were racial or ethnic minorities, and the majority were female and unemployed, with annual household incomes <$30 000 and publicly funded health insurance coverage.
For the intervention, an expert panel developed a reproducible, standardized massage therapy intended for individuals undergoing surgical port insertion. Both groups received 20-minute interventions immediately pre- and postsurgery. The research team collected data on pain and anxiety before and after the preoperative and postoperative interventions as well as 1 day after the surgery.
With respect to feasibility, the study examined (1) data about recruitment--time to complete enrollment and proportion of racial and ethnic minorities enrolled; (2) participants' retention; and (3) adherence to treatment allocation. The efficacy outcomes included measuring (1) participants' average pain level using an 11-point numerical rating scale (0 = no pain to 10 = worst possible pain) and (2) participants' situational anxiety using the State-Trait Anxiety Inventory (STAI).
The research team assigned the 60 patients to the groups over 53 weeks. Sixty-seven percent of the participants were racial or ethnic minorities. A majority were female and unemployed, with annual household incomes <$30 000 and publicly funded health insurance coverage. Of the 40 patients allocated to massage therapy, the majority (n = 33) received both the pre- and postoperative interventions. Massage therapy participants had a statistically significant, greater reduction in anxiety after the first intervention compared with individuals receiving structured attention (-10.27 vs -5.21, P = .0037).
Recruitment of low-income, minority patients into an RCT of massage therapy for perioperative pain and anxiety is feasible. Both massage therapy and structured attention proved beneficial for alleviating preoperative anxiety in cancer patients undergoing port placement.
尽管癌症治疗取得了重大进展,但许多患者在治疗过程中仍要接受痛苦的手术,并遭受使人虚弱的副作用,生活质量(QOL)也有所下降。对于低收入、少数种族和少数民族癌症患者而言,这一问题更为严重。少数族裔癌症患者就诊时往往肿瘤更大,病情更具侵袭性,出现疼痛和焦虑等使人虚弱症状的风险增加。研究人员从未评估过为正在接受端口植入术的低收入、服务不足的癌症患者提供按摩疗法的可行性和有效性。
本研究检验了开展一项随机对照试验(RCT)的可行性,该试验将评估按摩疗法对接受血管通路装置(端口)手术植入的城市癌症患者减轻疼痛和焦虑的效果。该研究还评估了该干预措施在减轻围手术期疼痛和焦虑方面的有效性。
研究团队对60例接受端口植入术的癌症患者进行了为期9个月的随机对照试验。研究团队以2:1的比例将患者随机分配至接受按摩疗法的常规护理组(干预组)和接受结构化关注的常规护理组(对照组)。
该研究在波士顿医疗中心(BMC)进行,这是一家城市三级转诊安全网医院。
参与者为正在接受端口植入术的癌症患者。67%为少数种族或少数民族,大多数为女性且失业,家庭年收入低于30000美元,拥有公共资助的医疗保险。
对于干预组,一个专家小组制定了一种可重复、标准化的按摩疗法,用于接受手术端口植入的个体。两组在术前和术后均立即接受20分钟的干预。研究团队在术前和术后干预前后以及术后1天收集了关于疼痛和焦虑的数据。
在可行性方面,该研究考察了:(1)关于招募的数据——完成入组的时间以及入组的少数种族和少数民族的比例;(2)参与者的留存率;(3)对治疗分配的依从性。疗效指标包括:(1)使用11点数字评定量表(0 = 无疼痛至10 = 可能的最严重疼痛)测量参与者的平均疼痛水平;(2)使用状态-特质焦虑量表(STAI)测量参与者的情境焦虑。
研究团队在53周内将60例患者分配至各小组。67%的参与者为少数种族或少数民族。大多数为女性且失业,家庭年收入低于30000美元,拥有公共资助的医疗保险。在分配至按摩疗法组的40例患者中,大多数(n = 33)接受了术前和术后干预。与接受结构化关注的个体相比,按摩疗法组参与者在首次干预后焦虑程度有统计学意义的更大程度降低(-10.27对-5.21,P = .0037)。
将低收入、少数族裔患者纳入按摩疗法减轻围手术期疼痛和焦虑的随机对照试验是可行的。按摩疗法和结构化关注均被证明有助于减轻接受端口植入术的癌症患者的术前焦虑。