Activity Based Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761824
• Other study ID #: 342186-7
• Status: Completed
• Phase: N/A
• First received: April 29, 2016
• Last updated: May 3, 2016
• Start date: June 2012
• Est. completion date: September 2014

Study information

• Verified date: May 2016
• Source: University of the Sciences in Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Camp Discovery
Activities included physical, social, emotional, sensory and spiritual activities.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of the Sciences in Philadelphia	Dolfinger-McMahon Foundation, Genesis Health System, M.D. Anderson Cancer Center, Temple University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Canadian Occupational Performance Measure Scores at 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	No
Primary	Change in World Health Organization-Quality of Life Brief (WHO-QoL BREF )scores at 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	No
Primary	Change in Short Form 36 (SF 36) at 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	No