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| ID | Type | Description | Link |
|---|---|---|---|
| JT 42246 | Other Identifier | JeffTrial Number |
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This small study tested a 3-month text-based health coaching program for men with prostate cancer on hormone therapy. The program was feasible and well accepted, with participants showing good engagement and some improvements in weight and quality of life. However, differences between groups were not statistically significant, so larger studies are needed to confirm the benefits.
Background/Objectives: This study aimed to assess the feasibility and acceptability of a 3-month health coaching intervention to promote PNF and healthy diet for men on ADT for PCa.
Methods: The study was carried out via a two-armed randomized controlled trial including 40 patients with PCa at a medical center in Philadelphia. During the 3-month period, the intervention group (PNF+) received health coaching utilizing an interactive text message system, and the control group received healthy eating text messages for the same duration. The outcome variables were feasibility and acceptability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Nightly Fasting (PNF+) | Experimental | Participants will be invited to participate in weekly calls with a trained health coach during the and will be encouraged to fast at least 12 hours nightly, gradually increasing to 16 hours. This will be complemented by an interactive TXT system. Participants will interact with the study platform, to report when they begin and end their overnight fasting as well as their sleeping behaviors. The platform will provide positive reinforcement messages when their fasting goal is successfully met as well as guidance and tips for fasting. The health eating attention control group: participants will |
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| Healthy Diet Group | Active Comparator | The health eating attention control group: participants will receive text messages twice a day to focus on information and tips on general healthy eating, based on AICR evidence-based materials. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Nightly Fasting (PNF+) | Behavioral | participants will be invited to participate in weekly counseling calls with a trained health coach and will be encouraged to fast at least 12 hours nightly, gradually increasing to 16 hours. This will be complemented by an interactive TXT system. Participants will interact with the study platform, to report when they begin and end their overnight fasting as well as their sleep pattern data. The platform will provide positive reinforcement messages when their fasting goal is successfully met as well as guidance and tips for fasting. |
| Measure | Description | Time Frame |
|---|---|---|
| Accrual Rate | Percentage of eligible participants who consent and enroll in the study. | 12 months |
| Attrition Rate | Percentage of enrolled participants completing post-intervention follow-up. | Approximately 3 months |
| Time-Restricted Eating Compliance | Percentage of participants compliant with 70% of the intervention days (70% of 90 days = 63 days) with suggested TRE | Approximately 3 months |
| Number of Adverse Events | Number of Adverse Events | Approximately 3 months |
| Patient Satisfaction | Patient satisfaction, as measured from Client Satisfaction Quesionnaire-8 item version (CSQ-8), a validated measure that elicits the client's perspective on the value of serves received37. Qualitatively, a structured interview guide will be developed to assess the behavioral determinants (barriers and facilitators to adoption of the 16:8 TRE, including the usefulness and practicality of the PNF+ intervention and any specific feedback for improvement. Sample questions include: asking participants to: 1) identify the greatest benefit from PNF+ program; 2) indicate the greatest challenge from be compliant with the PNF+ program; 3) describe the way in which their neurological function or memory had changed (improved or worsened); and 4) indicate the driving force that bring them to participate in the PNF+ program. | Approximately 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue short form. The FACIT-F includes 13 items, such as "I feel fatigued" and "I feel weak all over." Items are scored on a range from 0 to 52 with higher scores indicating better quality of life or less fatigue. This will be measured at baseline and all follow ups to inform future trials. The pre-post change scores will be calculated for each participant and standard deviations of the change scores. Intervention effects will be tested using Wilcoxon tests or Fisher's exact tests, as appropriate. |
Inclusion Criteria:
Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Kuang-Yi Wen, PhD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Participants will be randomized with an allocation ratio of 2:1 to either the PNF+ intervention group or Healthy Diet Group.
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| Healthy Diet Text Messaging | Behavioral | Healthy Diet Group will receive general messages about healthy diet derived from AICR. |
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| Baseline up to 3 months |
| Change in Weight | Weight: participants' weight will be collected from EMR and asked about self-reported weights during health coaching check in. The pre-post change scores will be calculated for each participant and standard deviations of the change scores. Intervention effects will be tested using Wilcoxon tests or Fisher's exact tests, as appropriate. | Baseline up to 3 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |