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临床试验/NCT02861703
NCT02861703已完成不适用

The Feasibility, Acceptability and Preliminary Effectiveness of an Online Lifestyle Intervention for Healthy Weight Management and Improved Quality of Life in Breast Cancer Survivors

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Change in Body Mass Index

研究概览

简要总结

Obesity presents serious psychological and physical consequences for breast cancer survivors, including diminished quality of life, poorer prognosis and increased mortality. As such, there is a great need to develop strategies for these women to maintain optimal body weight. Diet and exercise have been shown to lead to successful weight loss among this population but these effects are seldom sustained, plausibly because these efforts alone overlook less obvious, but equally important, psychosocial factors that can interfere with prolonged progress. This study will implement a group-based intervention addressing diet and exercise along with other psychosocial issues related to survivorship such as depression, fatigue, body image and social support. Based on the growing popularity and benefits of computer-based health care, including convenience and anonymity, this intervention will also be offered online, representing the first of its kind. It is hypothesized that the intervention will be feasible to implement and acceptable to its participants. It is also hypothesized that the intervention will yield meaningful and sustained changes in body weight, body mass index, waist circumference (primary outcomes), as well as mental well-being, quality of life, and body image (secondary outcomes). This research has the ability to improve the long-term health of breast cancer survivors by incorporating psychosocial interventions into standard medical care practices and has the potential to increase accessibility of these services using online technology.

详细描述

Breast cancer (BC) is one of the most common types of cancer in Canadian women, and although the mortality rate is decreasing, there remain numerous challenges for survivorship. Among the most prevalent yet less commonly discussed post-treatment concerns, is substantial weight gain, with approximately 70% of women being overweight at diagnosis and additional weight gain often resulting from treatment. Obesity has serious psychological and physical implications for both pre- and post-menopausal BC survivors; in addition to compromising body image and QoL, it increases risk for recurrence and mortality. Specifically, increased fat results in greater production of estrogen, insulin, leptin and pro-inflammatory cytokines, and lesser production of sex hormone binding globulin, all of which have been linked to the promotion of BC and tumor growth. As such, the development of strategies for the promotion and maintenance of optimal body mass has become a primary focus for BC survivorship.

Trials of lifestyle interventions for this population are in their early stages and have primarily included modification of diet alone, exercise alone, or both. Results have been mixed, especially regarding the effects of dietary change alone but generally support the benefits of exercise and combined diet and exercise on weight loss and improved QoL in cancer survivors. However, despite indications that diet and exercise interventions lead to improvements in physical health and mental health, there remains a lack of consistent evidence that these gains are maintained long-term. As such, there is a need for more systematic follow-up of these interventions to determine their potential to produce enduring effects as well as for development and refinement of techniques that improve long-term weight management.

Beyond developing effective services, a direction for future research should include outreach to underserved populations. Rural BC survivors represent one group, in particular, with limited access to healthy lifestyle interventions, and who could benefit greatly from participation. Compared to their urban counterparts, these women are less likely to have timely diagnostic biopsies and receive optimal treatment, and are diagnosed later, at more advanced stages when prognosis is less favourable. They are also more likely to be obese, be less physically active, have poor eating habits, experience psychological distress, and have less access to mental health resources, placing them at heightened risk for weight gain. Researchers and health care providers have a responsibility to develop ways of redressing such health disparities and helping these particularly vulnerable women make lasting changes to their overall health and QoL.

Society's recent movement toward "eHealth", which refers to "the use of emerging information and communication technology, especially the Internet, to improve or enable health and health care", introduces an exciting opportunity to increase availability of health care to BC survivors. Numerous eHealth diet and exercise interventions have been evaluated using community samples and have generally yielded mixed findings along with recommendations for refinement of future programs and more rigorous evaluation. Only one online community intervention has been in group-format, and to the investigators knowledge, no online, group-based lifestyle intervention has yet been developed specifically for BC survivors. Given the potential for broader delivery of health care services via the Internet, research surrounding the value of computer-based lifestyle interventions is especially warranted.

Present Study

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • be 21 years or older
  • have been diagnosed with primary BC (stages I-III)
  • have completed active treatment within the previous 5 years
  • have a BMI above 25 or report a weight increase of 10 pounds or more post-treatment,
  • be available to participate in 10 consecutive weeks of the online program
  • be comfortable using and have access to a computer and secure Internet connection 8) can read and write in English.

排除标准

  • diagnosis of metastatic cancer
  • diagnosis of a mental health condition that would interfere with their own, or another group members' ability to benefit from the group (e.g., psychosis)
  • diagnosis of an additional medical condition that is not being successfully managed/treated
  • plans to undergo a medical procedure within the next year
  • plans to participate in another structured weight loss program or take weight loss medication within the next year.

结局指标

主要结局

Change in Body Mass Index

时间窗: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up)

Measured as a function of participants' weight (kg), divided by their height (squared metres)

Change in Waist Circumference

时间窗: Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up)

Measured as the difference across time points on participants' waist circumference in inches, using a nonelastic measuring tape at the widest part of hips.

次要结局

  • Change in Dietary Intake(Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up))
  • Change in Subjective Health(Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up))
  • Change in 'Intuitive Eating' Habits(Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up))
  • Change in Self-Efficacy(Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up))
  • Change in Quality of Life(Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up))
  • Change in Life Satisfaction(Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up))
  • Change in Symptoms of Anxiety and Depression(Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up))
  • Change in Body Image(Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up))
  • Change in Objectified Body Consciousness(Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up))
  • Change in Exercise Habits(Baseline, 6 months (mid-treatment), 12 months (post-treatment), 18 months (6-month follow-up), 24 months (12-month follow-up))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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