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

Sponsor

Temple University (Other)

Overall Status

Completed

CT.gov ID

NCT02802787

Collaborator

University of the Sciences in Philadelphia (Other), M.D. Anderson Cancer Center (Other)

Enrollment

Location

Arm

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: Camp Discovery	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Camp Discovery One week activity based camp	Other: Camp Discovery Activities will include physical, social, emotional, sensory and spiritual activities.

Arm

Intervention/Treatment

Experimental: Camp Discovery

One week activity based camp

Other: Camp Discovery

Activities will include physical, social, emotional, sensory and spiritual activities.

Outcome Measures

Primary Outcome Measures

Change in Canadian Occupational Performance Measure Scores at Day1, Day 5 and Week 6 [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

Secondary Outcome Measures

Change in Brief Pain Inventory [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
Change in Brief Fatigue Inventory [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women diagnosed with cancer
Age of 21 of older
Clearance from their MD to participate in the activity program

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Community in Philadelphia	Philadelphia	Pennsylvania	United States	19130

Sponsors and Collaborators

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

Investigators

Principal Investigator: Rochelle J Mendonca, PhD, Temple University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Temple University

ClinicalTrials.gov Identifier:

NCT02802787

Other Study ID Numbers:

776234-4

First Posted:

Jun 16, 2016

Last Update Posted:

Apr 15, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Temple University

Study Results

No Results Posted as of Apr 15, 2020