Clinical trial NCT04961827: A Self-efficacy Based Dietary Intervention
Official title: Eat Well After Cancer: a Randomized Controlled Trial of a Self-efficacy Based Dietary Intervention Among Chinese Cancer Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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have often been used to facilitate improvements of dietary quality beyond nutrition counseling sessions but are outdated.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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes from baseline in mean dietary quality
timeFrame: Baseline and 3 months
measure: Changes from baseline in mean skin carotenoid reading
timeFrame: Baseline and 3 months
Secondary outcomes:
Other outcomes:
measure: Changes from baseline in mean self-efficacy score
timeFrame: Baseline and 3 months
Locations:
city: Hong Kong
country: Hong Kong
facility: JCICC
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Wendy Lam
role: PRINCIPAL_INVESTIGATOR
References: