Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:16 AM
Study NCT ID:
NCT07462403
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A mLifestyle Intervention for Men on Androgen Deprivation Therapy for PCa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized with an allocation ratio of 2:1 to either the mLifestyle intervention group or Healthy Diet Group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fatigue', 'timeFrame': 'Baseline up to 3 months', 'description': '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.'}, {'measure': 'Change in Weight', 'timeFrame': 'Baseline up to 3 months', 'description': "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."}], 'primaryOutcomes': [{'measure': 'Accrual Rate', 'timeFrame': '12 months', 'description': 'Percentage of eligible participants who consent and enroll in the study.'}, {'measure': 'Attrition Rate', 'timeFrame': 'Approximately 3 months', 'description': 'Percentage of enrolled participants completing post-intervention follow-up.'}, {'measure': 'Time-Restricted Eating Compliance', 'timeFrame': 'Approximately 3 months', 'description': 'Percentage of participants compliant with 70% of the intervention days (70% of 90 days = 63 days) with suggested TRE'}, {'measure': 'Number of Adverse Events', 'timeFrame': 'Approximately 3 months', 'description': 'Number of Adverse Events'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Approximately 3 months', 'description': "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 mLifestyle intervention and any specific feedback for improvement. Sample questions include: asking participants to: 1) identify the greatest benefit from mLifestyle program; 2) indicate the greatest challenge from be compliant with the mLifestyle 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 mLifestyle program."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Androgen Deprivation Therapy', 'ADT', 'metabolic disturbances', 'mobile text messaging', 'PCa', 'Nightly Fasting', 'telehealth coaching'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Participants in the study will have weekly phone calls with a trained health coach. During these calls, they will receive guidance on extending their overnight fasting time-starting with at least 12 hours and slowly working toward 16 hours each night. Participants will also use a text-message system to report when they start and stop fasting and to share information about their sleep. The system will send encouraging messages when they meet their fasting goals, along with tips and helpful reminders.\n\nHealthy Eating Attention Control Group:\n\nParticipants in this group will receive two text messages each day with simple, evidence-based information and tips on healthy eating. These messages are based on materials from the American Institute for Cancer Research (AICR).', 'detailedDescription': "Androgen deprivation therapy (ADT) is a common and effective treatment for prostate cancer (PCa), but it is associated with metabolic disturbances such as impaired glucose tolerance, insulin resistance, and weight gain. Men with PCa who are being evaluated for ADT already have a high prevalence of metabolic risk factors and face an increased risk of developing diabetes and potentially cardiovascular (CVD) mortality. Given the established benefits of meal-timing interventions on cardiovascular health and the demonstrated feasibility of using mobile text messaging (TXT) to support lifestyle behaviors in other populations, the investigators aim to evaluate, for one of the first times in this setting, the feasibility and acceptability of a telehealth coaching and interactive TXT-integrated intervention (mLifestyle-PCa). This intervention promotes a 16-hour nightly fasting duration among men receiving ADT for PCa.\n\nmLifestyle Intervention: Participants will engage 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. The counseling will be supplemented by an interactive TXT system through which participants will report the start and end times of their overnight fasts, as well as sleep pattern data. The platform will provide positive reinforcement when fasting goals are met and will offer guidance and practical tips. Participants randomized to the Healthy Diet Group will receive general healthy-eating messages derived from the American Institute for Cancer Research (AICR).\n\nThe investigators plan to approach up to 68 patients for participation and enroll 45 participants. Enrolled participants will be randomized 2:1 to the mLifestyle intervention versus the attention control (AC) condition, resulting in 30 participants in the mLifestyle arm and 15 in the AC arm.\n\nFor the primary aim, feasibility will be assessed through study accrual, attrition, time-restricted eating (TRE) compliance, and adverse event monitoring. The investigators aim for a 70% accrual rate, consistent with prior studies in similar populations, though rates above 60% will be considered acceptable. The intervention will be considered feasible if attrition does not exceed 30% and if at least 70% of participants adhere to the fasting protocol on at least 70% of study days (63 out of 90). The investigators anticipate few, if any, treatment-related adverse events (e.g., digestive issues), with rates above 10% deemed unacceptable. Acceptability will be assessed using a validated treatment satisfaction measure and patient interview data, with a group median score ≥28 on the CSQ-8 indicating high acceptability.\n\nThe investigators will also explore the potential impact of the mLifestyle intervention on secondary and exploratory outcomes. Pre-post change scores and standard deviations will be calculated for each participant, and intervention effects will be evaluated using Wilcoxon tests or Fisher's exact tests, as appropriate. These pilot findings will provide preliminary estimates of treatment effects and inform power calculations for larger future trials."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:\n\n * Must be 18 years of age or older\n * Provide signed and dated informed consent form\n * Had a histological diagnosis of PCa (Stage IIA-IVB)\n * 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.\n * Intermittent ADT will be allowed as long as the overall duration is more than 3 months.\n * BMI ≥25 kg/m2\n * Radiation therapy will be allowed concurrently.\n * Willing and able to comply with the protocol for the duration of the study\n * Able to speak, read and write English\n * Has a mobile phone with TXT capability.\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n * 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)\n * Patients on concurrent chemotherapy will be excluded.\n * ECOG score \\> 2\n * Medications such as finasteride/dutasteride/saw palmetto are not allowed.\n * Insulin injection or glyburide medication"}, 'identificationModule': {'nctId': 'NCT07462403', 'briefTitle': 'A mLifestyle Intervention for Men on Androgen Deprivation Therapy for PCa', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'A mLifestyle Intervention for Men on Androgen Deprivation Therapy for PCa', 'orgStudyIdInfo': {'id': '19S.725'}, 'secondaryIdInfos': [{'id': 'JT 42246', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mLifestyle', 'description': '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', 'interventionNames': ['Behavioral: mLifestyle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Diet Group', 'description': '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.', 'interventionNames': ['Behavioral: Healthy Diet Text Messaging']}], 'interventions': [{'name': 'mLifestyle', 'type': 'BEHAVIORAL', 'otherNames': ['interactive TXT-integrated intervention', 'Time-Restricted feeding'], 'description': '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.', 'armGroupLabels': ['mLifestyle']}, {'name': 'Healthy Diet Text Messaging', 'type': 'BEHAVIORAL', 'otherNames': ['health eating attention control group'], 'description': 'Healthy Diet Group will receive general messages about healthy diet derived from AICR.', 'armGroupLabels': ['Healthy Diet Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Kuang-Yi Wen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pennsylvania Department of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}