Prostate Cancer
Conditions
Keywords
Androgen Deprivation Therapy, ADT, metabolic disturbances, mobile text messaging, PCa, Nightly Fasting, telehealth coaching
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALProlonged Nightly Fasting (PNF+)
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.
BEHAVIORALHealthy Diet Text Messaging
Healthy Diet Group will receive general messages about healthy diet derived from AICR.
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomized with an allocation ratio of 2:1 to either the PNF+ intervention group or Healthy Diet Group.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: * Must be 18 years of age or older * Provide signed and dated informed consent form * Had a histological diagnosis of PCa (Stage IIA-IVB) * Are beginning or receiving ADT (including medical castration with LHRH-agonist-antagonist androgen receptor modulators) for PCa with an anticipated duration of ≥ 3 months. The ADT is defined as: (a) Gonadotropin Releasing Hormone (GNRH) agonist (including leuprolide \[Lupron/Eligard\], goserelin \[Zoladex\], triptorelin \[Trelstar\], histrelin \[Vantas\], and abiraterone \[Zytiga\]) alone; (b) GNRH agonist with oral androgen receptor blockade (including bicalutamide \[Casodex\], flutamide \[Eulexin\], and enzalutamide \[Xtandi\]), and (c) GNRH agonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors. Patients on androgen receptor modulators and second-generation androgen receptor antagonists will qualify. * Intermittent ADT will be allowed as long as the overall duration is more than 3 months. * BMI ≥25 kg/m2 * Radiation therapy will be allowed concurrently. * Willing and able to comply with the protocol for the duration of the study * Able to speak, read and write English * Has a mobile phone with TXT capability.
Exclusion criteria
* An individual who meets any of the following criteria will be excluded from participation in this study: * Inability to tolerate a normal diet (may include an active malabsorption syndrome at time of consent (i.e. Crohn's disease, major bowel resection leading to permanent malabsorption) * Patients on concurrent chemotherapy will be excluded. * ECOG score \> 2 * Medications such as finasteride/dutasteride/saw palmetto are not allowed. * Insulin injection or glyburide medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual Rate | 12 months | Percentage of eligible participants who consent and enroll in the study. |
| Attrition Rate | Approximately 3 months | Percentage of enrolled participants completing post-intervention follow-up. |
| Time-Restricted Eating Compliance | Approximately 3 months | Percentage of participants compliant with 70% of the intervention days (70% of 90 days = 63 days) with suggested TRE |
| Number of Adverse Events | Approximately 3 months | Number of Adverse Events |
| Patient Satisfaction | Approximately 3 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKuang-Yi Wen, PhD
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Outcome results
None listed