Colon Cancer
Conditions
Keywords
Web app, Older Adult, Prehabilitation
Brief summary
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.
Detailed description
PRIMARY OBJECTIVE: I. Determine the effectiveness of PrehabPal in delivering prehabilitation and improving outcomes for elders who undergo colorectal cancer surgery. SECONDARY OBJECTIVES: I. Determine the impact of PrehabPal on surgical outcomes and functional recovery compared to standard written surgery prehabilitation materials. OUTLINE: Participants 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.
Interventions
BEHAVIORALPrehabPal
Web based application
Sponsors
University of California, San Francisco
Emerson Collective
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomized in a 2:1 ratio
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female \>=65 years of age at time of evaluation for colorectal cancer resection. 2. Documentation of a colorectal diagnosis as evidenced by the following criteria: a. Biopsy proven colorectal cancer or unresectable neoplastic polyp. 3. 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. 4. Self-reported access to the Internet. 5. Participant has at least seven days prior to surgery date to optimize for surgery. 6. English language proficient.
Exclusion criteria
1. No English language proficiency. 2. No Internet access. 3. Documented diagnosis of dementia or Alzheimer's disease. 4. Surgery scheduled within 7-days. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of days before surgery engaged in prehabilitation | Up to 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with reported Surgical Complications | 30 days following surgery | Incidence of reported adverse events 30 days after surgery will be classified according to the Clavien-Dindo complications index. |
| Median Length of Stay (LOS) | Post procedure until discharge, approximately 2 days | The median time from surgery until discharge from hospital will be reported. |
| Readmission Rate | 30 days following surgery | The proportion of participants who were re-admitted to the hospital within 30 days of surgery will be reported. |
| Change in Mean score on the SF-36 | Up to 8 weeks | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmily Finlayson, MD, MS, FACS
University of California, San Francisco
Outcome results
None listed