Gastro Intestinal CancerNCT03576872
The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients
A study testing Psychoeducational in people with Gastro Intestinal Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating the use of a binder of educational materials with nurse teaching to prepare patients for chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Intestinal Cancer
- What is being tested?
- Psychoeducational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2018to 30 Sep 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read, write, and converse in English.
- 18 years or older
- Scheduled for a new chemotherapy start (intravenous) to treat adenocarcinoma of the pancreas or colorectal cancer
Who cannot join
- Enrolled in a clinical trial for chemotherapy
- Major psychological diagnoses that would limit participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
This research study is evaluating the use of a binder of educational materials with nurse teaching to prepare patients for chemotherapy
Read the detailed description
This research study is being done to investigate the feasibility of providing a binder of educational materials with nurse-led instruction in preparing pancreatic and colorectal cancer patients at Dana Farber for chemotherapy. The investigators want to evaluate whether the binder is helpful and usable for patients; and its effect on knowledge.
- Conditions
- Gastro Intestinal Cancer
- Being tested
- Psychoeducational
- Keywords
- Gastro Intestinal Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationalOther
Providing a binder of educational materials with nurse-led instruction in preparing pancreatic and colorectal cancer patients for chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational intervention | Experimental | * Psychoeducational will be conducted prior to chemotherapy.
* Teach session will occur prior and during administration of chemo
* A small quiz will be conducted to asses understanding of the educational binder Receives: Other: Psychoeducational |
What is being measured
The primary outcome is the main question the study is designed to answer.
80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants
Measured: 8 weeks
Secondary outcomes (6)
An average positive direction of change scores between participants' pre- and post- knowledge scores
Measured: 8 weeks
Average score of 24 or higher on the adapted Acceptability E-scale
Measured: 8 weeks
80% or higher on the index of rates for delivery of educational binders
Measured: 8 weeks
80% or higher on the index of rates for pre-chemotherapy teach sessions using the binders
Measured: 8 weeks
80% or higher on the index of rates for teach sessions using the binder on day 1 of chemotherapy
Measured: 8 weeks
80% or higher on the index of rates for follow-up phone calls and binder review prior to cycle 2 of chemotherapy
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start9 Jul 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Intestinal CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Jabaley, Dana-Farber Cancer Institute
- Investigators
- Theresa Jabaley, PhD, RN, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576872
- Sponsor's protocol ID
- 18-241
- Status last verified
- Oct 2020
- First submitted
- 22 Jun 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients
- ClinicalTrials.gov ID
- NCT03576872
- Acronym / sponsor ID
- 18-241
- Conditions
- Gastro Intestinal Cancer
- Keywords
- Gastro Intestinal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 3 Jul 2018 (actual)
- 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.
This research study is evaluating the use of a binder of educational materials with nurse teaching to prepare patients for chemotherapy
Detailed description
This research study is being done to investigate the feasibility of providing a binder of educational materials with nurse-led instruction in preparing pancreatic and colorectal cancer patients at Dana Farber for chemotherapy. The investigators want to evaluate whether the binder is helpful and usable for patients; and its effect on knowledge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational intervention | Experimental | Other: Psychoeducational* Psychoeducational will be conducted prior to chemotherapy. * Teach session will occur prior and during administration of chemo * A small quiz will be conducted to asses understanding of the educational binder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to read, write, and converse in English.
- 18 years or older
- Scheduled for a new chemotherapy start (intravenous) to treat adenocarcinoma of the pancreas or colorectal cancer
Key exclusion criteria (2 listed)
- Enrolled in a clinical trial for chemotherapy
- Major psychological diagnoses that would limit participation
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 |
|---|---|---|
| PsychoeducationalProviding a binder of educational materials with nurse-led instruction in preparing pancreatic and colorectal cancer patients for chemotherapy | Other | Psychoeducational intervention |
Primary outcome
80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants
Time frame: 8 weeks
6 secondary outcomes
An average positive direction of change scores between participants' pre- and post- knowledge scores
Time frame: 8 weeks
Average score of 24 or higher on the adapted Acceptability E-scale
Time frame: 8 weeks
80% or higher on the index of rates for delivery of educational binders
Time frame: 8 weeks
80% or higher on the index of rates for pre-chemotherapy teach sessions using the binders
Time frame: 8 weeks
80% or higher on the index of rates for teach sessions using the binder on day 1 of chemotherapy
Time frame: 8 weeks
80% or higher on the index of rates for follow-up phone calls and binder review prior to cycle 2 of chemotherapy
Time frame: 8 weeks
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 19 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Theresa Jabaley, PhD, RN principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational in people with Gastro Intestinal Cancer, run by Dana-Farber Cancer Institute 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?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 19 Oct 2020. 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?
80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants (time frame: 8 weeks). 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 19 Oct 2020.