CancerNCT02761824
Activity Based Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer
A study testing Camp Discovery in people with Cancer, run by University of the Sciences in Philadelphia.
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). Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Camp Discovery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women diagnosed with cancer
- age of 21 or older
- a clearance from their MD to participate in the activity program.
Who cannot join
- none
About this study
Official title: 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 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).
Read the detailed 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.
- Conditions
- Cancer
- Being tested
- Camp Discovery
- Keywords
- Quality of Life, Occupation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camp DiscoveryOther
Activities included physical, social, emotional, sensory and spiritual activities.
| Study group | Role | What they receive |
|---|---|---|
| Camp Discovery | Experimental | One week activity based camp. Receives: Other: Camp Discovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Day 1 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJun 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Sciences in Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, M.D. Anderson Cancer Center, Dolfinger-McMahon Foundation, Genesis Health System
- Responsible party
- Principal investigator, Colleen Maher, University of the Sciences in Philadelphia
- Investigators
- Colleen M Maher, OTD, Principal investigator, University of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761824
- Sponsor's protocol ID
- 342186-7
- Status last verified
- May 2016
- First submitted
- 29 Apr 2016
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29426382
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of an Activity Based Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer
- ClinicalTrials.gov ID
- NCT02761824
- Acronym / sponsor ID
- 342186-7
- Conditions
- Cancer
- Keywords
- Quality of Life, Occupation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of the Sciences in PhiladelphiaUniversity, hospital or other
- Collaborators
- Temple University, M.D. Anderson Cancer Center, Dolfinger-McMahon Foundation, Genesis Health System
- Study start
- Jun 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camp Discovery | Experimental | Other: Camp DiscoveryOne week activity based camp. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women diagnosed with cancer
- age of 21 or older
- a clearance from their MD to participate in the activity program.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camp DiscoveryActivities included physical, social, emotional, sensory and spiritual activities. | Other | Camp Discovery |
Primary outcome
Change in Canadian Occupational Performance Measure Scores at 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
Change in World Health Organization-Quality of Life Brief (WHO-QoL BREF )scores at Week 6
Time frame: Day 1 and 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.
Change in Short Form 36 (SF 36) at Week 6
Time frame: Day 1 and 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Derived from this study: PubMed 29426382Maher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen M Maher, OTD principal investigator
University of Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Camp Discovery in people with Cancer, run by University of the Sciences in Philadelphia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Canadian Occupational Performance Measure Scores at Day 5 and Week 6 (time frame: Day 1, Day 5 and week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02761824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.