Biobehavioral Effects of Qigong During Treatment for Rectal Cancer

描述（由申请人提供）：癌症及其治疗与相当大的痛苦，生活质量受损，精神健康状况不佳和身体功能下降有关。对于长期接受多模式治疗的直肠癌患者尤其如此。大多数患者将接受放射治疗，其次是手术，通常是化疗。重要的是要制定计划，可以帮助改善治疗相关的发病率，随着时间的推移积累的直肠癌患者。此外，考虑到接受放射治疗的紧张时间要求（患者通常每周接受5天治疗，持续6周），至关重要的是，程序可以轻松地纳入治疗计划。研究表明，针对癌症环境量身定制的减压计划有助于患者科普对治疗的急性影响，并改善治疗后的生活质量。气功，一种古老的做法，用于操纵自己的气（能量流），以有利于一个人的身体，情绪，心理，或精神健康结合减压技术，包括调节呼吸，视觉图像，冥想，和各种温柔的动作.气功可能是特别有用的直肠癌患者，而接受放射治疗和手术和化疗之前，因为压力管理和放松技术和温柔的动作，应该有利于恢复.在这个可行性/试点项目中，我们将试点测试和检查的可行性和实用性进行气功计划与直肠癌患者作为辅助他们的放射治疗.接受放疗治疗的直肠癌患者将被随机分配正在接受放化疗的直肠癌患者将被随机分配到气功组（QI），或轻度运动对照组（LE），或候补对照组（WL）。QI和LE组的受试者将在其6周放疗计划中每周参加3天的会议。会议将与治疗时间表协调，并在治疗设施附近进行。将在随机化前、放疗中期、放疗最后一周以及放疗结束后1个月和3个月进行简短评估。除了确定该计划的可接受性和可行性，本研究还将研究气功计划对疲劳和睡眠障碍的影响.调整的次要指标包括生活质量和心理健康。我们假设，气功计划将是可行的，患者会发现该计划可以接受和积极的经验.将气功计划整合到接受放射治疗的患者的治疗方案中将使其相对容易参与该计划，我们假设这样的计划将有助于促进恢复和减轻目前正在接受放射治疗的患者所经历的心理和生理副作用. 公共卫生相关性段落：拟议的研究将审查的可行性和初步效用，将气功计划与放疗患者直肠癌.如果我们发现，气功程序有利于恢复和治疗接受放射治疗的患者所经历的心理和生理副作用，那么这种类型的程序可以纳入治疗计划.由于拟议的试验是一个可行性/试点项目，因此需要进行更大规模的试验，并可能包括接受放疗的其他癌症人群。

DESCRIPTION (provided by applicant): Cancer and its treatment are associated with considerable distress, impaired quality of life, poor mental health, and reduced physical function. This is particularly true for patients with rectal cancer who receive multimodal treatment over an extended period of time. Most patients will undergo radiotherapy, followed by surgery and often chemotherapy. It is important to develop programs that can help ameliorate the treatment-related morbidity that accumulates over time for patients with rectal cancer. Furthermore, given the stressful time demands of undergoing radiotherapy (patients typically receive treatment 5 days per week for 6 weeks) it is crucial that programs be easily incorporated into the treatment schedule. Research suggests that stress- reduction programs tailored to the cancer setting help patients cope with the acute effects of treatment and improve QOL after treatment. Qigong, an ancient practice for manipulating one's own Qi (energy flow) to benefit one's physical, emotional, mental, or spiritual health incorporates stress-reduction techniques including regulated breathing, visual imagery, meditation, and various gentle movements. Qigong may be particularly useful for patients with rectal cancer while undergoing radiation treatment and prior to surgery and chemotherapy because of the stress management and relaxation techniques and the gentle movements that should facilitate recovery. In this feasibility/pilot project, we will pilot-test and examine the feasibility and usefulness of conducting a Qigong program with rectal cancer patients as an adjuvant to their radiotherapy treatment. Rectal cancer patients undergoing radiotherapy treatment will be randomly assigned Patients with rectal cancer who are undergoing chemo-radiotherapy will be randomly assigned to either a Qigong group (QI), or a light exercise control group (LE), or a waitlist control group (WL). Participants in the QI and LE groups will attend sessions 3 days/week throughout their 6-week radiotherapy schedule. The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility. Measures will be obtained prior to randomization, a brief assessment in the middle of radiotherapy, during last week of radiotherapy, and 1 and 3 months after the end of radiotherapy. In addition to determining the acceptability and feasibility of the program, this study will also examine the effects of the Qigong program on fatigue and sleep disturbances. Secondary indices of adjustment include QOL and mental health. We hypothesize that the Qigong program will be feasible and that patients will find the program acceptable and a positive experience. Integrating a Qigong program into the treatment regimen for patients undergoing radiotherapy will make it relatively easy to participate in the program and we hypothesize that such a program will help facilitate recovery and alleviate the psychological and physiological side effects experienced by patients who are currently undergoing radiotherapy. Public Health Relevance Paragraph: The proposed study will examine the feasibility and initial usefulness of incorporating a Qigong program alongside radiotherapy for patients with rectal cancer. If we find that the Qigong program facilitates recovery and alleviates the psychological and physiological side effects experienced by patients undergoing radiotherapy then this type of program can be incorporated into the treatment plan. As the proposed trial is a feasibility/pilot project a larger trial would need to be conducted and possibly include other cancer populations undergoing radiotherapy.