Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05377970
Other study ID # 1855206
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 25, 2022
Est. completion date July 31, 2024

Study information

Verified date October 2023
Source MaineHealth
Contact Laura Nicolais
Phone 207-662-2515
Email LNicolais@mmc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.


Description:

Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life. The investigators now hope to implement this prehabilitation program in the clinics at Maine Medical Center. Our long term goal is the introduce this program in all surgical specialties; but first, the investigators plan to assess adherence, patient self-efficacy, frailty and health-related quality of life through a pilot study in the surgical oncology clinic.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date July 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subjects =18 years old 2. Evaluated at Maine Medical Center by surgical oncology service 3. Planned surgical intervention for gastrointestinal oncologic condition 4. Score =40 on Risk Analysis Index frailty screening 5. Physically able to participate in prehabilitation exercises 6. Home internet access and established email account 7. Able to understand the English language Exclusion Criteria: 1. Patients unable to participate in exercises included in prehabilitation program 2. Patients with impaired decision making capacity 3. Those in a high risk community: prisoners and pregnant women 4. Those who do not meet the above inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Thinkific Prehabilitation Exercise Program
Prehabilitation exercise program through the Thinkific platform

Locations

Country Name City State
United States Maine Medical Center Portland Maine

Sponsors (2)

Lead Sponsor Collaborator
MaineHealth Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participant adherence to prehab program Evaluate adherence through analysis of patient maintained exercise logs via number of days completed Through study completion, on average 3 months
Primary Correlation between patient pre-program self-efficacy evaluation and measured adherence to study prehabilitation program Assess self-efficacy by evaluating the relationship between pre-program Self-Efficacy for Home Exercise Program Scale (0-72) score and adherence. Through study completion, on average 3 months
Primary Patient Satisfaction Assess patient satisfaction and barriers to adherence through a post prehab program survey. Last day of prehabilitation program (within week prior to surgery)
Primary Quality of Life (Short Form- 36 Survey) Evaluate change in health-related quality of life before and after participation in the prehabilitation program. Completed at Day 0, Two weeks, Four weeks and Last day of prehabilitation program (within week prior to surgery)
Primary Frailty (Risk Analysis Index) Evaluate change in frailty using Risk Analysis Index before and after participation in the prehabilitation program. Evaluated on Day 0 and at last visit prior to surgery, an average of 3 months
See also
  Status Clinical Trial Phase
Completed NCT01439152 - Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors. Phase 1
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Active, not recruiting NCT06015009 - Symptom Management App for Children at the Early Stage of Cancer Survivorship and Their Caregivers N/A
Active, not recruiting NCT03298100 - Risk Scoring Model for Endometrial Cancer
Recruiting NCT05055609 - Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors Phase 1
Not yet recruiting NCT04324320 - Psychological Distress in Outpatient Oncological Rehabilitation
Completed NCT00588289 - Long Term Follow-Up of Patients on Children's Cancer Group Protocols- (CCG-LTF1) FOLLOW-UP DATA N/A
Recruiting NCT06222801 - The 1st Tumor CytokinoTherapy Database (TCTD-1)
Recruiting NCT03831633 - Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Phase 4
Completed NCT04914702 - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Recruiting NCT05198570 - Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Recruiting NCT05712174 - A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer Phase 2
Recruiting NCT03832062 - Value of Analysing Under-utilised Leftover Tissue (VauLT)
Completed NCT03988777 - Magnetic Seed Localisation for Nonpalpable Breast Lesions
Recruiting NCT06031233 - Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie Phase 4
Enrolling by invitation NCT04019119 - Digital Intervention for the Modification of Lifestyles (iGame) N/A
Not yet recruiting NCT05926362 - Capillary-Venous Paired Data Collection
Recruiting NCT05686213 - ExeNTrO: Exercise During Neoadjuvant Chemoradiation Treatment to Improve Rectal and Esophageal Cancer Outcome - Pilot Trial Phase 2
Recruiting NCT05510856 - Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients Phase 4
Completed NCT04180306 - PEWS Implementation in an LMIC Setting N/A