Quality of LifeiPREHABNCT02082223
Individualized Preoperative Rehabilitation Pilot
A study testing Interventions to improve preop QOL/resilience deficits in people with Quality of Life and Complex Gastrointestinal Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
A pilot to test feasibility of improving patient/caretaker quality of life and resilience. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Complex Gastrointestinal Surgery
- What is being tested?
- Interventions to improve preop QOL/resilience deficits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 25 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Patients who are being seen for pancreatic, esophageal, rectal or hepatic neoplastic disease, will undergo neo-adjuvant therapy and may require complex GI surgery and their care givers.
- Are able and willing to participate in all aspects of the study; and
- Have been provided with, understand the consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Individualized Preoperative Rehabilitation (iPREHAB) Pilot
A pilot to test feasibility of improving patient/caretaker quality of life and resilience.
Read the detailed description
Our overall goal is to investigate if pre-operative interventions can address patients' and patients' care givers quality of life/resilience deficits and thus improve outcomes. This initial pilot study will test the feasibility of offering patients and their care givers prehabilitation interventions prior to complex gastrointestinal surgery such as pancreatectomy, esophagectomy, proctectomy, or hepatectomy.
- Conditions
- Quality of Life, Complex Gastrointestinal Surgery
- Being tested
- Interventions to improve preop QOL/resilience deficits
- Keywords
- Quality of life, Deficits, Complex gastrointestinal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions to improve preop QOL/resilience deficitsBehavioural
Also called Candidate interventions include, but not limited to:, Participate in SMART (Stress Management And Resiliency Training) program, Caregiver participation in Caregivers study protocol (IRB 13-002943), Nutritional recommendations (deficiencies, immuno-nutrition)
Identify patients' and patients' care givers quality of life/resilience deficits and supply information and resources prior to undergoing complex GI surgery.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Rehabilitation | Experimental | Patient \& caregiver input regarding 'single biggest concern right now' (modified BEACON buttons) will be elicited. Information gathered by the study team which includes a trained nursing coach and the patient/caregiver will together develop an individualized 'toolbox' of possible interventions to improve preoperative quality of life.
Candidate interventions include, but not limited to: Participation in SMART program, caregiver participation in Caregivers study protocol MC1295 (IRB 13-002943), nutritional recommendations (deficiencies, immuno-nutrition), low impact resistance training/tai chi, referral to financial or counseling services, establishment of information sources \& plans for concerns not frequently covered in clinical practice such as sleeplessness, spiritual assistance. Receives: Behavioral: Interventions to improve preop QOL/resilience deficits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Primary outcome is the feasibility of the interventions as measured through the end of study feedback form.
Measured: 3 months post surgical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completion25 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliane Bingener-Casey, Mayo Clinic
- Investigators
- Juliane Bingener-Casey, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082223
- Sponsor's protocol ID
- 13-005601
- Acronym
- iPREHAB
- Status last verified
- Feb 2018
- First submitted
- 6 Mar 2014
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Preoperative Rehabilitation (iPREHAB) Pilot
- ClinicalTrials.gov ID
- NCT02082223
- Acronym / sponsor ID
- iPREHAB / 13-005601
- Conditions
- Quality of Life, Complex Gastrointestinal Surgery
- Keywords
- Quality of life, Deficits, Complex gastrointestinal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- 25 Dec 2017 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot to test feasibility of improving patient/caretaker quality of life and resilience.
Detailed description
Our overall goal is to investigate if pre-operative interventions can address patients' and patients' care givers quality of life/resilience deficits and thus improve outcomes. This initial pilot study will test the feasibility of offering patients and their care givers prehabilitation interventions prior to complex gastrointestinal surgery such as pancreatectomy, esophagectomy, proctectomy, or hepatectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative Rehabilitation | Experimental | Behavioral: Interventions to improve preop QOL/resilience deficitsPatient \& caregiver input regarding 'single biggest concern right now' (modified BEACON buttons) will be elicited. Information gathered by the study team which includes a trained nursing coach and the patient/caregiver will together develop an individualized 'toolbox' of possible interventions to improve preoperative quality of life. Candidate interventions include, but not limited to: Participation in SMART program, caregiver participation in Caregivers study protocol MC1295 (IRB 13-002943), nutritional recommendations (deficiencies, immuno-nutrition), low impact resistance training/tai chi, referral to financial or counseling services, establishment of information sources \& plans for concerns not frequently covered in clinical practice such as sleeplessness, spiritual assistance. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventions to improve preop QOL/resilience deficitsAlso: Candidate interventions include, but not limited to:, Participate in SMART (Stress Management And Resiliency Training) program, Caregiver participation in Caregivers study protocol (IRB 13-002943), Nutritional recommendations (deficiencies, immuno-nutrition)Identify patients' and patients' care givers quality of life/resilience deficits and supply information and resources prior to undergoing complex GI surgery. | Behavioural | Preoperative Rehabilitation |
Primary outcome
Feasibility
Time frame: 3 months post surgical
Primary outcome is the feasibility of the interventions as measured through the end of study feedback form.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliane Bingener-Casey, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions to improve preop QOL/resilience deficits in people with Quality of Life and Complex Gastrointestinal Surgery, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 3 months post surgical). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.