Feasibility of an Individualized mHealth Nutrition (iNutrition) Intervention for Post-Discharged Gastric Cancer Patients Following Gastrectomy: A Randomized Controlled Pilot Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Design
2.2. Participants and Recruitment
- histologically confirmed gastric adenocarcinoma;
- received D2 radical gastrectomy;
- access to broadband internet;
- patient’s age ≥ 18 years;
- patient agreed to participate in this trial through informed consent.
2.3. Randomization and Blinding
2.4. Common Intervention for Both Groups
2.5. Specific Intervention (iNutrition Intervention)
2.5.1. Intervention Details
- (i)
- The iNutrition applet
- a.
- Gastrointestinal symptoms management
- b.
- Nutrition management
- c.
- Nutrition Knowledge
- d.
- Communication center
- (ii)
- Telephone-delivered Nutrition Consultation
2.5.2. Health Action Process Approach Theory
2.6. Outcomes
2.6.1. Quantitative Feasibility Measures
- Recruitment rate: the percentage of the eligible study population who agree to participate.
- Retention rate: the percentage of enrolled participants who completed the post-intervention evaluation.
- Adherence of the intervention participants: (1) number of planned nutrition consultations completed and average duration of the consultations; (2) register rate—participants registered on the iNutrition applet and participants were allocated to the intervention group × 100%; (3) number of logins into iNutrition applet from baseline to post-test; (4) the percentage of days that participants were active on the iNutrition applet during the 12-week intervention period; (5) percentage of registered participants who visited each module of the iNutrition applet. Adherence was recorded through the analytics function of the iNutrition applet, and records of attended nutrition consultations were kept.
- Acceptability of the participants of the intervention arm: this was determined through the System Usability Scale (SUS) and the Net Promoter Score (NPS) findings. The SUS is a valid and reliable 10-item usability measurement scale designed to evaluate software products, such as websites and applets, and was graded on a 5-point Likert scale [28]. The NPS is a validated one-item questionnaire (“How likely would you be to recommend iNutrition applet to a friend?”) on a scale of 1 to 10, with 1 being the least-probable and 10 being the most-probable for recommending this applet to others. Respondents with scores ranging from 0 to 6 are considered detractors, those with 7 or 8 are considered passive, and those with 9 or 10 are considered promoters. To compute the total NPS score, we divided the percentage of detractors by the percentage of promoters, yielding a single number ranging from −100% to +100%. Overall, a total NPS score greater than 0% indicated a stronger inclination to recommend the applet to others [29].
2.6.2. Embedded Qualitative Feasibility Measures
2.6.3. Secondary Outcomes
2.7. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Recruitment and Retention
3.3. Adherence and Acceptability
3.3.1. Adherence
3.3.2. System Usability Scale
3.3.3. Net Promoter Score
3.4. Qualitative Feasibility Data
3.5. Secondary Measures
4. Discussion
Strengths and Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristics | Intervention (n = 12) | Control (n = 12) | p-Value |
---|---|---|---|
Gender, n (%) | 1.00 b | ||
Male | 8 (66.7%) | 8 (66.7%) | |
Female | 4 (33.3%) | 4 (33.3%) | |
Age (years), mean (SD) | 54.08 (10.54) | 55.67 (9.98) | 0.78 a |
Education (years) | 14.17 ± 2.76 | 12.42 ± 3.73 | 0.76 c |
Work situation, n (%) | 1.00 b | ||
Employed | 6 (50%) | 5 (41.7%) | |
Unemployed | 2 (16.7%) | 3 (25%) | |
Retired | 4 (33.3%) | 4 (33.3%) | |
Chronic illnesses, n (%) | 1.00 b | ||
0 | 3 (25%) | 2 (16.7%) | |
1–2 | 5 (41.7%) | 6 (50%) | |
3 or above | 4 (33.3%) | 4 (33.3%) | |
Tumor location | 0.86 b | ||
Proximal | 2 (16.7%) | 2 (16.7%) | |
Middle | 3 (25%) | 5 (41.7%) | |
Distal | 7 (58.3%) | 5 (41.7%) | |
Pathological stage | 0.15 b | ||
I | 2 (16.7%) | 3 (25%) | |
II | 7 (58.3%) | 2 (16.7%) | |
III | 2 (16.7%) | 6 (50%) | |
IV | 1 (8.3%) | 1 (8.3%) | |
Resection extended | 1.00 b | ||
Partial gastrectomy | 9 (75%) | 9 (75%) | |
Total gastrectomy | 3 (25%) | 3 (25%) | |
Whether received Neoadjuvant treatment before the surgery | 1.00 b | ||
Yes | 4 (33.3%) | 4 (33.3%) | |
No | 8 (66.7%) | 8 (66.7%) | |
Baseline secondary outcomes (mean, SD) | |||
PG-SGA | 6.67 (2.23) | 7.58 (2.02) | 0.30 a |
NRS2002 | 4.92 (0.67) | 4.83 (0.39) | 0.59 c |
Weight | 60.52 (10.52) | 65.02 (9.85) | 0.29 a |
BMI | 22.37 (3.43) | 24.72 (2.93) | 0.09 a |
Energy intake | 225.07 (150.44) | 249.01 (100.34) | 0.20 c |
Protein intake | 7.28 (7.96) | 7.90 (5.38) | 0.35 c |
Compliance with energy requirements | 0.15 (0.10) | 0.15 (0.06) | 0.44 c |
Compliance with protein requirement | 0.10 (0.11) | 0.10 (0.07) | 0.59 c |
HAPA Scale | 3.73 (0.42) | 3.51 (0.29) | 0.14 a |
GSRS | 6.58 (3.58) | 7.25 (3.47) | 0.65 a |
QLQ-C30 | 78.60 (14.45) | 72.35 (12.29) | 0.27 a |
Program Component | |
---|---|
Telephone-delivered nutrition consultation | |
Attendance rate of nutrition consultation (mean ± SD) | 88.89% ± 12.98% |
Average duration of the nutrition consultations | 23.60 ± 8.94 min |
iNutrition applet | |
Register rate (until T2), n (%) | 100 (100%) |
Usage at T1, yes, n (%) | 11 (91.7%) |
Usage at T2, yes, n (%) | 7 (58.33%) |
Logins into the applet (T0-T2), Mdn (IQR) | 89 (98.25) |
The number of days active on the applet, Mdn (IQR) | 56.5 (20) |
Percentage of days active on the applet (T0-T2), Mean (SD) | 64.88% ± 28.04% |
Visits per module, n (%) | |
Module 1: Nutrition management | 12 (100%) |
Module 2: Gastrointestinal symptoms management | 9 (75%) |
Module 3: Nutrition Knowledge | 10 (83.33%) |
Module 4: Communication center | 10 (83.33%) |
Items | Mean Score (SD), Max = 5 |
---|---|
1. I think that I would like to use this system frequently | 4.36 ± 0.67 |
2. I found the system unnecessarily complex | 2.27 ± 0.65 |
3. I thought the system was easy to use | 4.36 ± 0.51 |
4. I think that I would need the support of a technical person to be able to use this system | 2.09 ± 1.14 |
5. I found the various functions in this system were well integrated | 3.82 ± 0.75 |
6. I thought there was too much inconsistency in this system | 1.91 ± 0.75 |
7. I would imagine that most people would learn to use this system very quickly | 4 ± 0.63 |
8. I found the system very cumbersome to use | 1.73 ± 0.65 |
9. I felt very confident using the system | 4.27 ± 0.47 |
10. I needed to learn a lot of things before I could get going with this system. | 1.91 ± 0.70 |
Measures | Intervention Group (n = 12) | Control Group (n = 12) | Group-by-Time Interaction Effects | Effect Size T0-T1 T1-T2 | |||
---|---|---|---|---|---|---|---|
Mean (SE) | Mean (SE) | Wald χ2 | β (95% CI) | p | d | ||
PG-SGA | T0 | 6.67 (0.62) | 7.58 (0.56) | 0.99 | |||
T1 | 7.83 (0.73) | 9.08 (0.79) | (p = 0.609) | −0.33 (−3.06, 2.39) | 0.811 | 0.10 | |
T2 | 5.50 (0.85) | 7.50 (0.86) | −1.08 (−3.50, 1.33) | 0.379 | 0.38 | ||
NRS2002 | T0 | 4.92 (0.19) | 4.83 (0.11) | 2.39 | |||
T1 | 3.33 (0.30) | 3.50 (0.28) | (p = 0.303) | −0.25 (−1.17, 0.67) | 0.593 | 0.23 | |
T2 | 2.75 (0.32) | 3.33 (0.25) | −0.67 (−1.60, 0.27) | 0.162 | 0.60 | ||
Weight | T0 | 60.52 (2.91) | 66.93 (2.64) | 3.33 | |||
T1 | 56.52 (2.40) | 62.12 (2.53) | (p = 0.189) | 0.82 (−1.48, 3.11) | 0.485 | 0.07 | |
T2 | 55.43 (2.38) | 59.50 (2.84) | 2.34 (−0.40, 5.08) | 0.094 | 0.78 | ||
BMI | T0 | 22.37 (0.95) | 24.72 (0.81) | 5.31 | |||
T1 | 20.96 (0.78) | 23.40 (0.74) | (p = 0.070) | −0.09 (−1.18, 0.99) | 0.868 | 0.07 | |
T2 | 20.57 (0.81) | 21.77 (0.73) | 1.15 (−0.07, 2.38) | 0.066 | 0.78 | ||
Energy intake | T0 | 225.07 (41.58) | 249.01 (27.73) | 6.54 | |||
T1 | 991.52 (115.78) | 770.00 (58.22) | (p = 0.038 *) | 245.47 (−18.18, 509.11) | 0.068 | 0.78 | |
T2 | 1072.52 (86.94) | 811.72 (56.64) | 284.74 (65.31, 504.17) | 0.011 * | 1.08 | ||
Protein intake | T0 | 7.28 (2.20) | 7.90 (1.49) | 4.85 | |||
T1 | 45.55 (7.41) | 40.40 (6.02) | (p = 0.088) | 5.76 (−13.95, 25.47) | 0.567 | 0.24 | |
T2 | 53.83 (6.33) | 38.68 (3.20) | 15.77 (0.26, 31.27) | 0.046 * | 0.85 | ||
Compliance with energy requirement | T0 | 0.15 (0.03) | 0.15 (0.02) | 10.28 | |||
T1 | 0.67 (0.07) | 0.51 (0.04) | (p = 0.006 *) | 0.17 (0.00, 0.33) | 0.046 * | 0.85 | |
T2 | 0.73 (0.05) | 0.53 (0.03) | 0.20 (0.08, 0.33) | 0.001 * | 1.27 | ||
Compliance with protein requirement | T0 | 0.10 (0.03) | 0.10 (0.02) | 9.57 | |||
T1 | 0.63 (0.09) | 0.56 (0.09) | (p = 0.008 *) | 0.08 (−0.18, 0.34) | 0.563 | 0.25 | |
T2 | 0.82 (0.08) | 0.52 (0.04) | 0.30 (0.09, 0.50) | 0.004 * | 1.19 | ||
HAPA | T0 | 3.73 (0.11) | 3.50 (0.08) | 10.52 | |||
T1 | 3.92 (0.08) | 3.03 (0.12) | (p = 0.005 *) | 0.67 (0.26, 1.07) | 0.001 * | 1.39 | |
T2 | 3.94 (0.12) | 3.08 (0.13) | 0.64 (0.17, 1.12) | 0.008 * | 1.12 | ||
GSRS | T0 | 6.58 (0.99) | 7.25 (0.96) | 1.02 | |||
T1 | 6.33 (1.46) | 9.17 (1.30) | (p = 0.601) | −2.17 (−6.74, 2.41) | 0.353 | 0.40 | |
T2 | 6.50 (1.41) | 8.92 (1.41) | −1.75 (−5.68, 2.18) | 0.382 | 0.37 | ||
QoL | T0 | 78.60 (3.99) | 72.35 (3.40) | 0.73 | |||
T1 | 77.08 (3.77) | 66.86 (3.46) | (p = 0.695) | 3.97 (−6.29, 14.23) | 0.448 | 0.32 | |
T2 | 75.61 (3.45) | 68.48 (3.09) | 0.89 (−8.12, 9.90) | 0.847 | 0.08 |
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Jiang, X.; Chen, J.; Yuan, X.; Lin, Y.; Chen, Y.; Li, S.; Jiang, Q.; Yu, H.; Du, Q.; Peng, J. Feasibility of an Individualized mHealth Nutrition (iNutrition) Intervention for Post-Discharged Gastric Cancer Patients Following Gastrectomy: A Randomized Controlled Pilot Trial. Nutrients 2023, 15, 1883. https://doi.org/10.3390/nu15081883
Jiang X, Chen J, Yuan X, Lin Y, Chen Y, Li S, Jiang Q, Yu H, Du Q, Peng J. Feasibility of an Individualized mHealth Nutrition (iNutrition) Intervention for Post-Discharged Gastric Cancer Patients Following Gastrectomy: A Randomized Controlled Pilot Trial. Nutrients. 2023; 15(8):1883. https://doi.org/10.3390/nu15081883
Chicago/Turabian StyleJiang, Xiaohan, Jiamin Chen, Xiuhong Yuan, Yijia Lin, Yingliang Chen, Sijia Li, Qiuxiang Jiang, Hong Yu, Qianqian Du, and Junsheng Peng. 2023. "Feasibility of an Individualized mHealth Nutrition (iNutrition) Intervention for Post-Discharged Gastric Cancer Patients Following Gastrectomy: A Randomized Controlled Pilot Trial" Nutrients 15, no. 8: 1883. https://doi.org/10.3390/nu15081883