- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02761824
Activity Based Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer
May 3, 2016 updated by: Colleen Maher, University of the Sciences in Philadelphia
Implementation and Evaluation of an Activity Based Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer
Implementation and Evaluation of an Activity Based Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer.
Demonstrate improved life satisfaction (with evidenced gathered at three consecutive periods and geographical locations through Quality of Life surveys).
Study Overview
Detailed Description
This research study focused on developing and implementing eight one-week activity camps in the summer of 2012, 2013, and 2014 for women diagnosed with cancer.
Each camp was held in a different geographical location: rural (Renovo, PA), suburban (Gilda's Club in Warminster, PA), MD Anderson of Camden, and urban (University of the Sciences with the Cancer Support Community of Philadelphia).
The focus of this programming was to allow women to engage in activities they may not be engaged in since the diagnosis of cancer and to provide them with opportunities to socially interact and communicate with individuals who may have encountered the same difficulties as them.
Quality of life information was collected before, during and after implementation of the activity program.
The main objective was to demonstrate improved life satisfaction (with evidenced gathered at three consecutive periods and geographical locations through Quality of Life surveys).
77 women were recruited over a three year period.
6 dropped out and 71 completed the entire study.
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women diagnosed with cancer
- age of 21 or older
- a clearance from their MD to participate in the activity program.
Exclusion Criteria: Not Applicable (NA)
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Camp Discovery
One week activity based camp.
|
Activities included physical, social, emotional, sensory and spiritual activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Canadian Occupational Performance Measure Scores at Day 5 and Week 6
Time Frame: Day 1, Day 5 and week 6
|
Individualized, client-centered measure designed for use by occupational therapists to detect change in a client's self-perception of occupational performance and satisfaction over time
|
Day 1, Day 5 and week 6
|
Change in World Health Organization-Quality of Life Brief (WHO-QoL BREF )scores at Week 6
Time Frame: Day 1 and week 6
|
Quality of Life Measure: Assesses the individual's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
|
Day 1 and week 6
|
Change in Short Form 36 (SF 36) at Week 6
Time Frame: Day 1 and week 6
|
Multi-purpose, short-form health survey with 36 questions.
Yields a profile of functional health and well-being scores.
Provides psychometrically based physical and mental health summary measures.
|
Day 1 and week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Colleen M Maher, OTD, University of Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
April 29, 2016
First Submitted That Met QC Criteria
May 3, 2016
First Posted (Estimate)
May 4, 2016
Study Record Updates
Last Update Posted (Estimate)
May 4, 2016
Last Update Submitted That Met QC Criteria
May 3, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 342186-7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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