CancerMDACC-MOHONCT01983332
Impact of MOHO on Therapists Working With Clients in Cancer Population
An observational study of Cancer, run by Texas Woman's University at 2 sites in United States.
Trial summary
The purpose of this study is to examine the impact of an introduction to the occupation-based theory (MOHO) on the clinical reasoning of therapists working with cancer clients. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Cancer
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to Aug 2017
- Phase
- Observational
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be outpatient-focused therapists working within the MD Anderson Cancer Center. Participants must have worked in this setting for at least 90 days before the study begins and will self-select to participate in the study. Recruitment of therapists at the MDACC will involve an introduction of the study by an onsite collaborator. The onsite collaborator will gather the names of individuals interested in participating in the study. Then, an onsite collaborator and PI will work together to determine if the therapists meet the inclusion criteria for the study. Once the therapists are determined to meet inclusion criteria, an invitation for participation will be extended by an onsite collaborator.
Who may be able to join
- No training in MOHO constructs,English speaking.
Who cannot join
- Training in using MOHO concepts in practice, highly skilled in use of MOHO, and non-English speaking. If a therapist is skilled and knowledgeable of the constructs of MOHO, there will be no way to determine if introduction of the model has impacted a therapist's clinical reasoning. All the materials used for the study will be in English and analysis of data will be conducted by English speaking individuals, therefore the study participants must speak English.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
M.D. Anderson Cancer Center
Houston, Texas, 77030
Texas Woman's University
Houston, Texas, 77030
About this study
Official title: Impact of the Introduction of Model of Human Occupation (MOHO) on Clinical Reasoning in Therapists Working With Clients in the Cancer Population
The purpose of this study is to examine the impact of an introduction to the occupation-based theory (MOHO) on the clinical reasoning of therapists working with cancer clients.
Read the detailed description
The study will occur at MDACC, a comprehensive cancer center in the Texas Medical Center (TMC) in Houston. The center is the largest freestanding comprehensive cancer center in the world. The facility provides inpatient and outpatient services and supports research and education.
The facility has more than 50 buildings in the greater Houston area and in central Texas. The setting for this study will be the rehabilitation services area on the main campus in the TMC.
There are private offices, conference rooms and treatment areas where video chats and monthly meetings will occur.
The study is projected to occur over a one year period. Sessions will be videotaped (video chats - initial and follow ups and monthly group meetings) for further review. Analysis of the tapes will provide data for further research and education presentations. Sessions will also be audiotaped and transcribed for further review and data analysis purposes. Neither the videotapes nor audiotapes will be shared with anyone at the facility or any uninvolved parties. Audiotapes and videotapes will be stored in locked file cabinets and password protected computers will be used to view and analyze the audio and video tapes. Only the research team will have access to the stored data locked in the file cabinet.
- Conditions
- Cancer
- Keywords
- MDACC, MOHO
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| occupational therapists | Occupational Therapists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interviews and training sessions-observational analysis of video taped sessions
The study will begin with a video chat (20-30 minutes) to attain a baseline of participants understanding of MOHO. An initial video chat interview guide (Appendix B) will be used to facilitate the chat session and a training session on MOHO concepts (4-8 hours) will also be held (Appendix F). The training session is a 6 part overview of the MOHO framework. All following video chats will be conducted using the follow up video chat interview guide (Appendix C). There will be 8 follow up video chat sessions (20-30 minutes) occurring every 6 weeks after the initial training session on MOHO concepts. Video chat sessions will be facilitated by a research team member. There will be 12 monthly group meetings (60-90 minutes) with all participants to allow a time to discuss use of MOHO in practice and troubleshoot issues and offer support in a formal manner. The monthly group meeting will be facilitated by the PI and/or an onsite collaborator. The maximum possible time commitment stands at 1830
Measured: 30 1/2 hours over course of year
Secondary outcomes (1)
Observational data analysis-theme sorting until saturation reached
This is a qualitative study and data will be analyzed using theme sorting until commonn themes are determined.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Patricia Bowyer, Texas Woman's University
- Investigators
- Patricia Bowyer, EdD,MS,OTR, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983332
- Sponsor's protocol ID
- 17075
- Acronym
- MDACC-MOHO
- Status last verified
- Oct 2017
- First submitted
- 5 Jul 2013
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Introduction of Model of Human Occupation (MOHO) on Clinical Reasoning in Therapists Working With Clients in the Cancer Population
- ClinicalTrials.gov ID
- NCT01983332
- Acronym / sponsor ID
- MDACC-MOHO / 17075
- Conditions
- Cancer
- Keywords
- MDACC, MOHO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Aug 2013 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 14 Nov 2013 (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 purpose of this study is to examine the impact of an introduction to the occupation-based theory (MOHO) on the clinical reasoning of therapists working with cancer clients.
Detailed description
The study will occur at MDACC, a comprehensive cancer center in the Texas Medical Center (TMC) in Houston. The center is the largest freestanding comprehensive cancer center in the world. The facility provides inpatient and outpatient services and supports research and education.
The facility has more than 50 buildings in the greater Houston area and in central Texas. The setting for this study will be the rehabilitation services area on the main campus in the TMC.
There are private offices, conference rooms and treatment areas where video chats and monthly meetings will occur.
The study is projected to occur over a one year period. Sessions will be videotaped (video chats - initial and follow ups and monthly group meetings) for further review. Analysis of the tapes will provide data for further research and education presentations. Sessions will also be audiotaped and transcribed for further review and data analysis purposes. Neither the videotapes nor audiotapes will be shared with anyone at the facility or any uninvolved parties. Audiotapes and videotapes will be stored in locked file cabinets and password protected computers will be used to view and analyze the audio and video tapes. Only the research team will have access to the stored data locked in the file cabinet.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| occupational therapists | – | –Occupational Therapists |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be outpatient-focused therapists working within the MD Anderson Cancer Center. Participants must have worked in this setting for at least 90 days before the study begins and will self-select to participate in the study. Recruitment of therapists at the MDACC will involve an introduction of the study by an onsite collaborator. The onsite collaborator will gather the names of individuals interested in participating in the study. Then, an onsite collaborator and PI will work together to determine if the therapists meet the inclusion criteria for the study. Once the therapists are determined to meet inclusion criteria, an invitation for participation will be extended by an onsite collaborator.
Key inclusion criteria (1 listed)
- No training in MOHO constructs,English speaking.
Key exclusion criteria (1 listed)
- Training in using MOHO concepts in practice, highly skilled in use of MOHO, and non-English speaking. If a therapist is skilled and knowledgeable of the constructs of MOHO, there will be no way to determine if introduction of the model has impacted a therapist's clinical reasoning. All the materials used for the study will be in English and analysis of data will be conducted by English speaking individuals, therefore the study participants must speak English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interviews and training sessions-observational analysis of video taped sessions
Time frame: 30 1/2 hours over course of year
The study will begin with a video chat (20-30 minutes) to attain a baseline of participants understanding of MOHO. An initial video chat interview guide (Appendix B) will be used to facilitate the chat session and a training session on MOHO concepts (4-8 hours) will also be held (Appendix F). The training session is a 6 part overview of the MOHO framework. All following video chats will be conducted using the follow up video chat interview guide (Appendix C). There will be 8 follow up video chat sessions (20-30 minutes) occurring every 6 weeks after the initial training session on MOHO concepts. Video chat sessions will be facilitated by a research team member. There will be 12 monthly group meetings (60-90 minutes) with all participants to allow a time to discuss use of MOHO in practice and troubleshoot issues and offer support in a formal manner. The monthly group meeting will be facilitated by the PI and/or an onsite collaborator. The maximum possible time commitment stands at 1830
1 secondary outcome
Observational data analysis-theme sorting until saturation reached
Time frame: 1 year
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 13 Oct 2017.
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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.
Patricia Bowyer, EdD,MS,OTR principal investigator
Texas Woman's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Texas Woman's University at 2 sites 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 1 inclusion and 1 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Interviews and training sessions-observational analysis of video taped sessions (time frame: 30 1/2 hours over course of year). 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 Oct 2017.