Health and Rehabilitation Sciences Research Institute, University of Ulster, Newtownabbey, Co. Antrim, BT 37 0QB, UK.
Gynecol Oncol. 2011 Sep;122(3):618-24. doi: 10.1016/j.ygyno.2011.05.029.
To determine the feasibility and efficacy of a physical activity behavioural change intervention in managing cancer-related fatigue among gynaecological cancer survivors during and post anti-cancer treatments.
A two arm, single blind, randomised controlled trial was conducted within the Northern Ireland regional Cancer Centre. Thirty three sedentary gynaecological cancer survivors (stage I-III; ≤3 years post diagnosis), experiencing cancer-related fatigue (mild-severe) took part. Participants were randomly assigned to a behavioural change, moderate intensity physical activity intervention (n=16) or a Contact Control group (n=17). The primary outcome was fatigue (Multidimensional Fatigue Symptom Inventory-Short Form and Functional Assessment in Chronic Illness Therapy-Fatigue subscale). Secondary outcomes included quality of life, physical functioning, positive and negative affect, depression, body composition, sleep dysfunction and self-reported physical activity. Feasibility was assessed based on the recruitment rate, programme and physical activity adherence and participants' programme evaluation, including optional focus groups (n=16).
Twenty five percent of eligible women took part (33/134). Participants were 8.7 (SD=9.1) months post diagnosis, with a mean age of 53 (SD=10.3) years. The majority of the sample had a diagnosis of ovarian (n=12) or endometrial cancer (n=11). Significant differences favouring the intervention group were observed for fatigue at 12 weeks and 6 months follow-up (12 week: mean difference=-11.06; 95% confidence interval (CI)=-21.89 to -0.23; effect size (d)=0.13; p=0.046; 6 month: mean difference=-19.48; 95% CI=-19.67 to -19.15; effect size (d)=0.20; p=0.01). A mean of 10 calls (SD=1.2 calls) were delivered to the Physical Activity Group, and 10 (SD=1.6 calls) to the CC group. The intervention was positively perceived based on exit questionnaire and focus group findings.
A physical activity behavioural change intervention for gynaecological cancer survivors is feasible in terms of participants' programme adherence and evaluation, and the intervention demonstrates improvements in fatigue. However, confirmation in the form of a larger fully powered RCT is warranted.
在癌症治疗期间和之后，确定针对妇科癌症幸存者的身体活动行为改变干预在管理癌症相关疲劳方面的可行性和疗效。
在北爱尔兰区域癌症中心进行了一项两臂、单盲、随机对照试验。33 名患有妇科癌症（I-III 期；诊断后≤3 年）且经历癌症相关疲劳（轻度-重度）的久坐不动的癌症幸存者参加了该试验。参与者被随机分配到行为改变、中等强度的身体活动干预组（n=16）或接触对照组（n=17）。主要结局是疲劳（多维疲劳症状量表-简短版和慢性疾病治疗-疲劳子量表的功能评估）。次要结局包括生活质量、身体功能、积极和消极情绪、抑郁、身体成分、睡眠障碍和自我报告的身体活动。基于招募率、方案和身体活动依从性以及参与者的方案评估来评估可行性，包括可选的焦点小组（n=16）。
25%的合格女性参与了研究（33/134）。参与者在诊断后 8.7（SD=9.1）个月，平均年龄为 53（SD=10.3）岁。大多数样本的诊断为卵巢癌（n=12）或子宫内膜癌（n=11）。在 12 周和 6 个月的随访中，干预组的疲劳显著改善（12 周：平均差异=-11.06；95%置信区间（CI）=-21.89 至 -0.23；效应大小（d）=0.13；p=0.046；6 个月：平均差异=-19.48；95%CI=-19.67 至-19.15；效应大小（d）=0.20；p=0.01）。对身体活动组进行了 10 次（SD=1.2 次）通话，对 CC 组进行了 10 次（SD=1.6 次）通话。根据退出问卷和焦点小组的调查结果，该干预措施得到了积极的评价。
针对妇科癌症幸存者的身体活动行为改变干预在参与者的方案依从性和评估方面是可行的，并且该干预措施在疲劳方面显示出改善。然而，需要更大规模的完全有力的 RCT 来证实。
