跳至主要内容
临床试验/NCT04961827
NCT04961827终止不适用

Eat Well After Cancer: a Randomized Controlled Trial of a Self-efficacy Based Dietary Intervention Among Chinese Cancer Survivors

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年7月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
68
试验地点
1
主要终点
Changes from baseline in mean skin carotenoid reading

研究概览

简要总结

To develop and test the effectiveness of a dietary intervention aiming to enhance self-efficacy through sending images through instant messaging.

详细描述

Healthy eating is linked to improved survival and quality of life among cancer survivors. However, previous studies showed that most cancer survivors were not adhering to dietary recommendations despite having made changes post-diagnosis.

Conventional nutrition counseling interventions are often used in this population. However, they are labor and cost intensive and involved multiple sessions with participants. Written materials have often been used to facilitate improvements of dietary quality beyond nutrition counseling sessions but are outdated. Therefore, we propose to develop and test the effectiveness of a dietary intervention aiming to enhance self-efficacy through sending images through instant messaging. Methods to increase self-efficacy include performance accomplishment, persuasion, modelling and peer-modelling.

A prospective, randomized controlled trial design will be used to test the effectiveness of the intervention. A total of 168 adult Chinese cancer survivors, diagnosed with non-metastatic cancer (Stages 0-III), and have completed all active treatments, including surgery and adjuvant treatments such as chemotherapy and radiation therapy will be recruited.

Participants will be randomly assigned into one of two groups at a 1:1 ratio, using computer-generated block randomization sequences. The first group will be an active control group. Participants in this group will receive knowledge-based dietary information through an instant messaging applications biweekly for 6 times. The second group will be the intervention group. Participants will receive biweekly self-efficacy enhancing materials for 6 times. Materials will provide information about behavior-health link, provide information on consequences, provide instruction, and provide opportunities for social comparison. For example, the materials will provide recipe ideas and meal planning samples from fellow cancer survivors. All materials will be developed by a registered dietitian and will be consistent with published dietary guidelines for cancer survivors.

Participants will have follow-up appointments at 3 months. Their dietary quality and skin carotenoid status will be monitored. It is hypothesized that dietary quality will be better and skin carotenoid status will be higher for participants in the intervention group compared to participants in the active control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Aged 18 or above
  • Diagnosed with cancer, non-metastatic (Stages 0-III)
  • Ability to read Chinese and speak Cantonese or Putonghua/Mandarin
  • Completed all active treatments, including surgery and adjuvant treatments such as chemotherapy and radiation therapy
  • Attending clinic with nutrition counseling at study site

排除标准

  • Ethnicity other than Chinese
  • Diagnosed with mental, hearing, speech, or cognitive disabilities

结局指标

主要结局

Changes from baseline in mean skin carotenoid reading

时间窗: Baseline and 3 months

Skin carotenoid status reading measured by a reflective spectroscopy machine

Changes from baseline in mean dietary quality

时间窗: Baseline and 3 months

Servings of fruit and vegetables per day, number of red meat servings per week and ratio of whole to refined grains measured by a 3-day dietary record self-completed by participants before baseline and 3-months follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wendy Wing Tak Lam

Associate Professor

The University of Hong Kong

研究点 (1)

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