Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-02-02 @ 11:47 AM
Study NCT ID:
NCT05520866
Status:
RECRUITING
Last Update Posted:
2025-05-02
First Post:
2022-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PrehabPal: A Digital Tool to Help Older Adults Prepare for Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will be randomized in a 2:1 ratio'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2022-08-26', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Median Satisfaction Scores', 'timeFrame': '8 weeks post-surgery', 'description': 'Patient-participant reported satisfaction with the PrehabPal web app and the paper-mode activities diary will be measured via a survey created by the investigators in REDCap.'}], 'primaryOutcomes': [{'measure': 'Proportion of days before surgery engaged in prehabilitation', 'timeFrame': 'Up to 14 days', 'description': 'The proportion of days before surgery engaged in prehabilitation between subjects randomized to the PrehabPal Web App and written prehabilitation materials using logistic regression. Since sites may not balance, all relevant sociodemographic and clinical characteristics of the subjects may be included in the models which will include other factors that are not balanced between the sites.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with reported Surgical Complications', 'timeFrame': '30 days following surgery', 'description': 'Incidence of reported adverse events 30 days after surgery will be classified according to the Clavien-Dindo complications index.'}, {'measure': 'Median Length of Stay (LOS)', 'timeFrame': 'Post procedure until discharge, approximately 2 days', 'description': 'The median time from surgery until discharge from hospital will be reported.'}, {'measure': 'Readmission Rate', 'timeFrame': '30 days following surgery', 'description': 'The proportion of participants who were re-admitted to the hospital within 30 days of surgery will be reported.'}, {'measure': 'Change in Mean score on the SF-36', 'timeFrame': 'Up to 8 weeks', 'description': 'Short Form 36 (SF-36) Health Survey: includes 36 items or questions that assess functional health and well-being from the perspective of the patient. The items contribute to eight health domains of physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. The eight domains all contribute to physical component summary (PCS) and mental component summary (MCS) scores Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. The calculated composite scores of the Physical Component Scale (PCS) and the Mental Component Scale (MCS) scores of the SF-36 will be measured at baseline and 8 weeks post surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Web app', 'Older Adult', 'Prehabilitation'], 'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '31968063', 'type': 'BACKGROUND', 'citation': 'Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474.'}, {'pmid': '23052535', 'type': 'BACKGROUND', 'citation': 'Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.'}, {'pmid': '39965940', 'type': 'DERIVED', 'citation': 'Ogomori K, Broering J, Rogine C, Kin C, Chang GJ, Finlayson E. Evaluating a digital prehabilitation tool in patients with colorectal surgery: protocol for a multisite randomised controlled trial. BMJ Open. 2025 Feb 18;15(2):e088001. doi: 10.1136/bmjopen-2024-088001.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized trial investigating the use of PrehabPal web app versus a written surgery prehabilitation instructions among individuals aged 65 years and older preparing for colon cancer surgery. PrehabPal is a web app designed with, and for, older adults preparing for surgery at University of California, San Francisco (UCSF). This app has the potential to fill a crucial clinical gap for older cancer patients by designing an individualized prehabilitation program and providing prehabilitation coaching.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Determine the effectiveness of PrehabPal in delivering prehabilitation and improving outcomes for elders who undergo colorectal cancer surgery.\n\nSECONDARY OBJECTIVES:\n\nI. Determine the impact of PrehabPal on surgical outcomes and functional recovery compared to standard written surgery prehabilitation materials.\n\nOUTLINE:\n\nParticipants will be randomly assigned to 1 of 2 conditions. Study participation will continue for up to 12 weeks, with intervention 7-21 days before surgery and a follow-up visit 8 weeks after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female \\>=65 years of age at time of evaluation for colorectal cancer resection.\n2. Documentation of a colorectal diagnosis as evidenced by the following criteria:\n\n a. Biopsy proven colorectal cancer or unresectable neoplastic polyp.\n3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n4. Self-reported access to the Internet.\n5. Participant has at least seven days prior to surgery date to optimize for surgery.\n6. English language proficient.\n\nExclusion Criteria:\n\n1. No English language proficiency.\n2. No Internet access.\n3. Documented diagnosis of dementia or Alzheimer's disease.\n4. Surgery scheduled within 7-days.\n5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data."}, 'identificationModule': {'nctId': 'NCT05520866', 'briefTitle': 'PrehabPal: A Digital Tool to Help Older Adults Prepare for Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'PrehabPal: A Digital Tool to Help Frail Elders Prepare for Cancer Surgery', 'orgStudyIdInfo': {'id': '228013'}, 'secondaryIdInfos': [{'id': '22-37253', 'type': 'OTHER', 'domain': 'University of California, San Francisco'}, {'id': 'NCI-2023-02952', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PrehabPal Web app', 'description': 'Web app based initial geriatric assessment will be given followed by daily tailored prehabilitation activities in the domains of exercise, nutrition, anxiety reduction, home preparation, and advanced care planning. Each participant is paired with a central health coach who monitors engagement and provides support through the Web app portal.', 'interventionNames': ['Behavioral: PrehabPal']}, {'type': 'NO_INTERVENTION', 'label': 'Written Surgery Prehabilitation Instructions', 'description': 'Participants will be provided paper-based prehabilitation instructions that include information about exercise, nutrition, anxiety reduction, home preparation, and advanced care planning. A paper diary is provided to record any prehabilitation activities.'}], 'interventions': [{'name': 'PrehabPal', 'type': 'BEHAVIORAL', 'description': 'Web based application', 'armGroupLabels': ['PrehabPal Web app']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yukino Nakamura', 'role': 'CONTACT', 'email': 'Yukino.Nakamura@ucsf.edu'}, {'role': 'CONTACT', 'email': 'cancertrials@ucsf.edu', 'phone': '877-827-3222'}, {'name': 'Emily Finlayson, MD, MS, FACS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '73030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mingxuan Xu', 'role': 'CONTACT', 'email': 'mxu2@mdanderson.org'}, {'name': 'George Chang, MD, MS, MHCM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Yukino Nakamura', 'role': 'CONTACT', 'email': 'Yukino.Nakamura@ucsf.edu', 'phone': '877-827-3222'}], 'overallOfficials': [{'name': 'Emily Finlayson, MD, MS, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Emerson Collective', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}