Integrating an Occupational Therapy Health and Wellness Program Into an Existing Cancer Support Community

NCT03888547 | Completed

• 1 other identifier: 0987
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

occupational therapy; health; wellness

Outcome Measures

Primary Outcomes (4)

• Canadian Occupational Performance Measure (COPM) change

  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.

  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)

• Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-G)

  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.

  Change from baseline COPM to 4 weeks post

• Pittsburgh Sleep Quality Index (PSQI) change

  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.

  Change from baseline PSQI to 4 weeks post

• Multidimensional Assessment of Fatigue Scale (MAF) change

  Multidimensional Assessment of Fatigue Scale (MAF) is an open access, self-reported questionnaire that measures fatigue with recommended use in cancer rehabilitation.

  Change from baseline MAF to 4 weeks post

Study Arms (1)

OT-HAWP

EXPERIMENTAL

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

Interventions

Occupational Therapy Health & Wellness Education OTHER

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).

OT-HAWP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Requires legal guardian to provide consent due to cognitive deficits

Sponsors & Collaborators

• University of Indianapolis: lead
• Indiana Clinical and Translational Sciences Institute: collaborator

Study Sites (1)

Cancer Support Community

Indianapolis, Indiana, 46268, United States

Location

Related Publications (10)

• Heinrich Heine (2013). *G Power 3 Software. Retrieved from: http://www.psycho.uni-duesseldorf.de/abteilungen/aap/gpower3/download-and-register.

  RESULT

• 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

  RESULT

• Baxter MF, Newman R, Longpre SM, Polo KM. Occupational Therapy's Role in Cancer Survivorship as a Chronic Condition. Am J Occup Ther. 2017 May/Jun;71(3):7103090010P1-7103090010P7. doi: 10.5014/ajot.2017.713001.

  PMID: 28422624 RESULT

• Pergolotti M, Cutchin MP, Weinberger M, Meyer AM. Occupational therapy use by older adults with cancer. Am J Occup Ther. 2014 Sep-Oct;68(5):597-607. doi: 10.5014/ajot.2014.011791.

  PMID: 25184473 RESULT

• Polo KM, Smith C. Taking Our Seat at the Table: Community Cancer Survivorship. Am J Occup Ther. 2017 Mar/Apr;71(2):7102100010p1-7102100010p5. doi: 10.5014/ajot.2017.020693.

  PMID: 28218583 RESULT

• Hunter EG, Gibson RW, Arbesman M, D'Amico M. Systematic Review of Occupational Therapy and Adult Cancer Rehabilitation: Part 1. Impact of Physical Activity and Symptom Management Interventions. Am J Occup Ther. 2017 Mar/Apr;71(2):7102100030p1-7102100030p11. doi: 10.5014/ajot.2017.023564.

  PMID: 28218585 RESULT

• Carswell A, McColl MA, Baptiste S, Law M, Polatajko H, Pollock N. The Canadian Occupational Performance Measure: a research and clinical literature review. Can J Occup Ther. 2004 Oct;71(4):210-22. doi: 10.1177/000841740407100406.

  PMID: 15586853 RESULT

• Jensen RE, Potosky AL, Moinpour CM, Lobo T, Cella D, Hahn EA, Thissen D, Smith AW, Ahn J, Luta G, Reeve BB. United States Population-Based Estimates of Patient-Reported Outcomes Measurement Information System Symptom and Functional Status Reference Values for Individuals With Cancer. J Clin Oncol. 2017 Jun 10;35(17):1913-1920. doi: 10.1200/JCO.2016.71.4410. Epub 2017 Apr 20.

  PMID: 28426375 RESULT

• Grandner MA, Kripke DF, Yoon IY, Youngstedt SD. Criterion validity of the Pittsburgh Sleep Quality Index: Investigation in a non-clinical sample. Sleep Biol Rhythms. 2006 Jun;4(2):129-139. doi: 10.1111/j.1479-8425.2006.00207.x. Epub 2006 Jun 9.

  PMID: 22822303 RESULT

• Winstead-Fry P. Psychometric assessment of four fatigue scales with a sample of rural cancer patients. J Nurs Meas. 1998 Winter;6(2):111-22.

  PMID: 10028778 RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

• Katie Polo

  University of Indianapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: March 25, 2019
• Study Start: February 11, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)