NCT02802787

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

3.2 years

First QC Date

June 2, 2016

Last Update Submit

April 13, 2020

Conditions

Keywords

Quality of lifeOccupationPainFatigue

Outcome Measures

Primary Outcomes (1)

  • Change in Canadian Occupational Performance Measure Scores at Day1, 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 Outcomes (2)

  • Change in Brief Pain Inventory

    Day 1, Day 5, and week 6

  • Change in Brief Fatigue Inventory

    Day 1, Day 5, and week 6

Study Arms (1)

Camp Discovery

EXPERIMENTAL

One week activity based camp

Other: Camp Discovery

Interventions

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

Camp Discovery

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community in Philadelphia

Philadelphia, Pennsylvania, 19130, United States

Location

MeSH Terms

Conditions

NeoplasmsPainFatigue

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rochelle J Mendonca, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 16, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

April 15, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations