CancerNCT02802787
Implementation and Evaluation of an Activity Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer
A study testing Camp Discovery in people with Cancer, run by Temple University at 1 site in United States.
Trial 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). 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
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Aug 2019
- 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 of older
- Clearance from their MD to participate in the activity program
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Community in Philadelphia
Philadelphia, Pennsylvania, 19130
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, 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).
Read the 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.
- Conditions
- Cancer
- Being tested
- Camp Discovery
- Keywords
- Quality of life, Occupation, Pain, Fatigue
- Medical subject headings
- Neoplasms, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camp DiscoveryOther
Activities will include 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 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
Measured: Day 1, Day 5 and week 6
Secondary outcomes (2)
Change in Brief Pain Inventory
Pain assessment that measures level of pain will be reported for Day 1, Day 5, and Week 6
Measured: Day 1, Day 5, and week 6
Change in Brief Fatigue Inventory
Fatigue assessment that measures level of Fatigue will be reported for Day 1, Day 5, and Week 6
Measured: Day 1, Day 5, 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 posted16 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Sciences in Philadelphia, M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Rochelle J Mendonca, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802787
- Sponsor's protocol ID
- 776234-4
- Status last verified
- Apr 2020
- First submitted
- 2 Jun 2016
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. 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
- NCT02802787
- Acronym / sponsor ID
- 776234-4
- Conditions
- Cancer
- Keywords
- Quality of life, Occupation, Pain, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- University of the Sciences in Philadelphia, M.D. Anderson Cancer Center
- Study start
- Jun 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 16 Jun 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, 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).
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
- 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 of older
- 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 will include physical, social, emotional, sensory and spiritual activities. | Other | Camp Discovery |
Primary outcome
Change in Canadian Occupational Performance Measure Scores at Day1, 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
2 secondary outcomes
Change in Brief Pain Inventory
Time frame: Day 1, Day 5, and week 6
Change in Brief Fatigue Inventory
Time frame: Day 1, Day 5, and week 6
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 15 Apr 2020.
- 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.
Rochelle J Mendonca, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camp Discovery in people with Cancer, run by Temple University at 1 site in United States.
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 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Day1, Day 5 and Week 6 (time frame: Day 1, Day 5 and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2020.