Implementation and Evaluation of an Activity Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer

April 13, 2020 updated by: Temple University

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, Pain and Fatigue Outcomes in Women Diagnosed With Cancer. Demonstrate improved life satisfaction, decreased pain and decreased fatigue (with evidenced gathered at three consecutive periods Quality of Life, Pain and Fatigue surveys).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research study will focus on developing and implementing two one-week activity camps in the summer of 2016 for women diagnosed with cancer. One camp will be held in West Philadelphia and another in Camden, New Jersey, both of which have been identified as underserved areas for health access. The focus of this programming is 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, pain and fatigue information will be collected before, during and after implementation of the activity program. The main objective is to demonstrate improved life satisfaction, decreased pain and decreased fatigue (with evidenced gathered at three consecutive periods and geographical locations through Quality of Life, Pain and Fatigue surveys). The intended sample size is 57 women.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19130
        • Community in Philadelphia

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 of older
  • Clearance from their MD to participate in the activity program

Exclusion Criteria:

  • 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
Other: Camp Discovery
Activities will include 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 Day1, 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief Pain Inventory
Time Frame: Day 1, Day 5, and week 6
Pain assessment that measures level of pain will be reported for Day 1, Day 5, and Week 6
Day 1, Day 5, and week 6
Change in Brief Fatigue Inventory
Time Frame: Day 1, Day 5, and week 6
Fatigue assessment that measures level of Fatigue will be reported for Day 1, Day 5, and Week 6
Day 1, Day 5, and week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

M.D. Anderson Cancer Center
University of the Sciences in Philadelphia

Investigators

  • Principal Investigator: Rochelle J Mendonca, PhD, Temple University

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, 2016

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 776234-4

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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