Advanced CancersNCT02521194
Occupational Therapy in Palliative Care
A study testing Questionnaire in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn if inpatient occupational therapy can help patients in the Palliative Care Unit (PCU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2015to 5 Jan 2020
- 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
- Patients must have an inpatient occupational therapy (OT) order and be able to tolerate an OT session as judged by the attending physician
- Patients with cancer admitted to inpatient acute palliative care unit
- Caregiver participation is optional, but must be identified as the primary caregiver in order to complete the Caregiver Satisfaction Survey.
- Caregiver (if participating) must be present during the session.
- Patient (and caregiver (if participating) must be 18 years of age or older.
- Both patient (and caregiver if participating) must be able to understand, read, write and speak English.
- Both patient and caregiver (if participating) must sign an Informed Consent Form.
Who cannot join
- Patients or caregivers with physical limitations (visual or motor impairment) causing inability to read, complete or sign the consent form and survey.
- Patients or caregivers who the attending physician deems unable to participate due to poor cognitive capacity or acute physical distress.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Is Inpatient Occupational Therapy Perceived to be Beneficial by the Palliative Patient and Caregiver?
The goal of this research study is to learn if inpatient occupational therapy can help patients in the Palliative Care Unit (PCU).
Read the detailed description
Caregivers Consent:
If you agree to take part in this study, you will complete a questionnaire about your opinion on the inpatient occupational therapy session the patient (person you are caring for) received. It should take about 10 minutes to complete the questionnaire. You will be left alone in a room to complete the questionnaire.
Length of Study:
Your participation on this study will be over after you complete the questionnaire.
This is an investigational study.
50 patients and up to 50 caregivers will take part in this study. All will be enrolled at MD Anderson.
Patients Consent:
If you agree to take part in this study, you will complete a questionnaire about your opinion of the inpatient occupational therapy session you just had. The questionnaire should take about 10 minutes to complete. You will be left alone in the room to complete the questionnaire.
Length of Study:
You participation on this study will be over after you complete the questionnaire.
This is an investigational study.
50 patients and up to 50 caregivers will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Questionnaire
- Keywords
- Advanced Cancers, Inpatient occupational therapy, Questionnaire, Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaire completion regarding opinion of the inpatient occupational therapy session patient received.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver Questionnaire | Experimental | Questionnaire completion regarding opinion on the inpatient occupational therapy session person being cared for received. Receives: Behavioral: Questionnaire |
| Patient Questionnaire | Experimental | Questionnaire completion regarding opinion of the inpatient occupational therapy session patient received. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction Rate of Inpatient Occupational Therapy Session
Satisfaction rate defined as the percentage of patients that "strongly agree" or "agree" after inpatient occupational session as being beneficial.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start13 Nov 2015
- Primary completion5 Jan 2020
- Study completion5 Jan 2020
Why it stopped: PI requested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul W. Walker, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521194
- Sponsor's protocol ID
- 2015-0350
- Status last verified
- Jan 2020
- First submitted
- 10 Aug 2015
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Inpatient Occupational Therapy Perceived to be Beneficial by the Palliative Patient and Caregiver?
- ClinicalTrials.gov ID
- NCT02521194
- Acronym / sponsor ID
- 2015-0350
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Inpatient occupational therapy, Questionnaire, Survey
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI requested
- Enrolment
- 86 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 5 Jan 2020 (actual)
- Study completion
- 5 Jan 2020 (actual)
- First posted
- 13 Aug 2015 (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.
The goal of this research study is to learn if inpatient occupational therapy can help patients in the Palliative Care Unit (PCU).
Detailed description
Caregivers Consent:
If you agree to take part in this study, you will complete a questionnaire about your opinion on the inpatient occupational therapy session the patient (person you are caring for) received. It should take about 10 minutes to complete the questionnaire. You will be left alone in a room to complete the questionnaire.
Length of Study:
Your participation on this study will be over after you complete the questionnaire.
This is an investigational study.
50 patients and up to 50 caregivers will take part in this study. All will be enrolled at MD Anderson.
Patients Consent:
If you agree to take part in this study, you will complete a questionnaire about your opinion of the inpatient occupational therapy session you just had. The questionnaire should take about 10 minutes to complete. You will be left alone in the room to complete the questionnaire.
Length of Study:
You participation on this study will be over after you complete the questionnaire.
This is an investigational study.
50 patients and up to 50 caregivers will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregiver Questionnaire | Experimental | Behavioral: QuestionnaireQuestionnaire completion regarding opinion on the inpatient occupational therapy session person being cared for received. |
| Patient Questionnaire | Experimental | Behavioral: QuestionnaireQuestionnaire completion regarding opinion of the inpatient occupational therapy session patient received. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have an inpatient occupational therapy (OT) order and be able to tolerate an OT session as judged by the attending physician
- Patients with cancer admitted to inpatient acute palliative care unit
- Caregiver participation is optional, but must be identified as the primary caregiver in order to complete the Caregiver Satisfaction Survey.
- Caregiver (if participating) must be present during the session.
- Patient (and caregiver (if participating) must be 18 years of age or older.
Key exclusion criteria (2 listed)
- Patients or caregivers with physical limitations (visual or motor impairment) causing inability to read, complete or sign the consent form and survey.
- Patients or caregivers who the attending physician deems unable to participate due to poor cognitive capacity or acute physical distress.
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 |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaire completion regarding opinion of the inpatient occupational therapy session patient received. | Behavioural | Caregiver Questionnaire, Patient Questionnaire |
Primary outcome
Satisfaction Rate of Inpatient Occupational Therapy Session
Time frame: 1 day
Satisfaction rate defined as the percentage of patients that "strongly agree" or "agree" after inpatient occupational session as being beneficial.
Results and safety
The study was stopped early (reason given: PI requested). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Paul W. Walker, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Advanced Cancers, run by M.D. Anderson Cancer Center 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 7 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: stopped early, as of the sponsor's last update on 13 Jan 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 was stopped early (reason given: PI requested). Results are not available in the source record.
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?
Satisfaction Rate of Inpatient Occupational Therapy Session (time frame: 1 day). 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 13 Jan 2020.