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Integrating an Occupational Therapy Health and Wellness Program Into an Existing Cancer Support Community (OT-HAWP)

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ClinicalTrials.gov Identifier: NCT03888547
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
Indiana Clinical and Translational Sciences Institute
Information provided by (Responsible Party):
Katie M. Polo, MHS, OTR/L, CLT-LANA, University of Indianapolis

Brief Summary:

The number of cancer survivors today is growing exponentially and many survivors have unmet needs due to the late side effects of treatment. The purpose of this study is to explore the impact that a four-week Occupational Therapy Health and Wellness Program has on perceived satisfaction and performance of daily activities, fatigue, sleep quality, and health-related quality of life among adult community-dwelling cancer survivors.

Eligibility criteria for prospective participants includes cancer survivors with a past or present diagnosis that are at least 18 years old, able to consent, are English speaking, are able to fill out demographic information as well as pretest/posttest questionnaires, have indicated concerns within performance of daily activities and are able and willing to participate in a four-week Occupational Therapy Health and Wellness Program.

This quantitative study will use a prospective, one-group pretest-posttest design to explore the effects of a four-week Occupational Therapy Health and Wellness Program. Data that will be collected to track changes include physical, mental, and social health (measured by PROMIS questionnaire); fatigue levels (measured by the MAF questionnaire); Sleep quality (measured by the PSQI questionnaire); and self-perceived occupational performance and satisfaction (measured by the COPM interview/questionnaire) of community-dwelling cancer survivors.

Descriptive statistics will be used to compare pretest/posttest scores. Matched pairs t-test and Wilcoxin signed ranks test will be used if data is normally distributed. Normality will be tested by Shapiro wilks test and all data will be analyzed using t-tailed tests with significance set at .05.


Condition or disease Intervention/treatment Phase
Cancer Other: Occupational Therapy Health & Wellness Education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integrating an Occupational Therapy Health and Wellness Program (OT-HAWP) Into an Existing Cancer Support Community
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: OT-HAWP

The OT Health and Wellness Program will have four weeks of education and individual integration intervention modules:

Week 1: Sleep Hygiene Week 2: Fatigue Management Week 3: Cancer-related cognitive impairments Week 4: Stress Management Each session will last 1.5 hours (45 minutes of group education and 45 minutes of individual modifications and strategy recommendations.

Other: Occupational Therapy Health & Wellness Education
The OT Health and Wellness Program will have four weeks of education and individual integration intervention modules. One of the investigators will lead each of these weekly modules under the direct supervision of the Principal Investigator. Investigators will be trained to provide the standardized educational module for each topic area and for using outcome measures. Each module will have an identified theme and information provided in each group will be education to topic, evidence based literature on intervention strategies, lifestyle, or environmental modifications that improve performance of daily activities that will last approximately 45 minutes. After, group sharing of ideas and individual identification of weekly goals for integration of 1-3 targeted interventions will occur and last approximately 30-45 minutes).




Primary Outcome Measures :
  1. Canadian Occupational Performance Measure (COPM) change [ Time Frame: pretest/post test: COPM will be collected at first intake appointment prior to the first OT-HAWP module and after the last OT-HAWP (4 weeks) ]
    Canadian Occupational Performance Measure (COPM) is a client centered outcome instrument that measures changes in a client's self-perception of occupational performance and satisfaction over time, and has been found to be a valid, reliable, and clinically useful outcome measure for occupational therapy research. In step two, the client is asked to rate the importance of each of the occupations to his/her life using a 10-point rating scale, the client is asked to use a 10 point scale to rate their own level of performance and satisfaction with performance for each of the five identified problems.

  2. Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-G) [ Time Frame: Change from baseline COPM to 4 weeks post ]
    Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-G) is an open access, person-centered questionnaire that measures physical, mental, and social health of adults, has been rigorously tested, has strong psychometric properties, and has cancer specific reference values. It is a 5 point likert scale.

  3. Pittsburgh Sleep Quality Index (PSQI) change [ Time Frame: Change from baseline PSQI to 4 weeks post ]
    Pittsburgh Sleep Quality Index (PSQI) is an open access, self-reported questionnaire that measures sleep quality and patterns in adults over a 1-month time interval, and has been found to be a reliable and valid assessment of sleep problems.

  4. Multidimensional Assessment of Fatigue Scale (MAF) change [ Time Frame: Change from baseline MAF to 4 weeks post ]
    Multidimensional Assessment of Fatigue Scale (MAF) is an open access, self-reported questionnaire that measures fatigue with recommended use in cancer rehabilitation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Has present or past diagnosis of cancer
  • Has indicated concerns affecting daily performance of activities, showing a need for OT programming
  • Has access to Central Indiana Chapter of Cancer Support Community (CSC)
  • Is able to consent
  • Is able and willing to participate in demographic survey and pretest/posttest questionnaires
  • Is able and willing to participate in a four-week Occupational Therapy Health and Wellness Program
  • Is able to speak and understand English

Exclusion Criteria:

• Requires legal guardian to provide consent due to cognitive deficits


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888547


Contacts
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Contact: Sharaya Sommers 260-355-9622 sesomm16@gmail.com

Locations
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United States, Indiana
Cancer Support Community Recruiting
Indianapolis, Indiana, United States, 46268
Contact: Sharaya Sommers    260-355-9622    sesomm16@gmail.com   
Sponsors and Collaborators
University of Indianapolis
Indiana Clinical and Translational Sciences Institute
Investigators
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Principal Investigator: Katie Polo University of Indianapolis

Publications of Results:
Heinrich Heine (2013). *G Power 3 Software. Retrieved from: http://www.psycho.uni-duesseldorf.de/abteilungen/aap/gpower3/download-and-register.
American Cancer Society (2018). Cancer Facts and Figures Retrieved from https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2018.html

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Responsible Party: Katie M. Polo, MHS, OTR/L, CLT-LANA, Assistant Professor, University of Indianapolis
ClinicalTrials.gov Identifier: NCT03888547     History of Changes
Other Study ID Numbers: 0987
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katie M. Polo, MHS, OTR/L, CLT-LANA, University of Indianapolis:
occupational therapy
health
wellness