NCT02761824

Brief 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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable cancer

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, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

April 29, 2016

Last Update Submit

May 3, 2016

Conditions

Keywords

Quality of LifeOccupation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Camp Discovery

EXPERIMENTAL

One week activity based camp.

Other: Camp Discovery

Interventions

Activities included 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 or older
  • a 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

Related Publications (1)

  • Maher C, Mendonca RJ. Impact of an Activity-Based Program on Health, Quality of Life, and Occupational Performance of Women Diagnosed With Cancer. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205040p1-7202205040p8. doi: 10.5014/ajot.2018.023663.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Colleen M Maher, OTD

    University of Sciences

    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
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 4, 2016

Study Start

June 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 4, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share