CancerNCT01831375
Cancer Prevention and Care Among Aged
A study testing Speak Up and Get connected in people with Cancer, run by Case Western Reserve University at 1 site in United States.
Trial summary
This research represents a pioneering effort to design a brief, cost effective and readily transportable program that will enable disadvantaged elders to become more effective participants in their health care. The intervention is expected to result in trained elders becoming more knowledgeable health care partners. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Speak Up and Get connected
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 697 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2016
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women
- Over the age of 65 from Area Agencies of Aging who are interested in participating
Who cannot join
- No exclusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Health Care Partners in Cancer Prevention and Care Among Aged
This research represents a pioneering effort to design a brief, cost effective and readily transportable program that will enable disadvantaged elders to become more effective participants in their health care.
The intervention is expected to result in trained elders becoming more knowledgeable health care partners. Trained patients will be prepared for appointments and will engage their primary care physicians in active dialogue regarding cancer prevention and screening.
Based on self-advocacy, these patients are expected to receive better preventive care and report greater satisfaction with care. Program participation can subsequently contribute to general health improvements and minimize health disparities.
Read the detailed description
In a randomized controlled trial (RCT) with 400 older adults, the investigators will assess the efficacy of the "Speak Up" intervention (N=200) relative to an attention control group "Connect" program (N=200), aimed at enhancing social and civic engagement. Participants will now obtain resource materials that include decision aids and diary logs to bring to visits with doctors. The investigators will implement "Speak Up" and "Connect" programs in two unique study populations: 1) participants in the ongoing NCI study and 2) older adults attending senior center programs sponsored by Area Agencies on Aging (AAAs). Participants will be assessed prior to the intervention and 2 month, and 12 months post intervention. The investigators will have an observation window of 12 months to determine whether and when the older adult obtained screening. The selection of a shorter follow-up time frame will help reduce attrition.
- Conditions
- Cancer
- Being tested
- Speak Up, Get connected
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speak UpBehavioural
Also called The Involved Elders Project
Intervention group_treatment group
Get connectedBehavioural
Participants will learn to be connected with social resources in the community.
| Study group | Role | What they receive |
|---|---|---|
| Speak Up | Experimental | Participants will learn how to speak up to their medical doctors for improving their medical care. Receives: Behavioral: Speak Up |
| Get Connected | Other | Attention control group Receives: Behavioral: Get connected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of Physician Quality Scale
Perception of Physician Quality Scale(Lee \& Kasper, 1998) will be used to measure patient satisfaction with physician care (p. 21). Questions include satisfaction with physician visits and satisfaction with physician knowledge of respondent's medical problems. This scale has been utilized with elderly populations (e.g. Burton et al. 2002) and has been found to be a valid and reliable (Cronbach's alpha greater than .8) measure of patient satisfaction (Lee \& Kasper, 1998).
Measured: one year
Secondary outcomes (1)
Cancer Screening Recommendations
Physicians would make more recommendations for cancer prevention and screening
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2016
- Study completionDec 2016
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 697 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Kahana, Ph.D., Case Western Reserve University
- Investigators
- Eva Kahana, Ph.D., Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831375
- Sponsor's protocol ID
- R01CA098966-07
- Status last verified
- Jan 2017
- First submitted
- 11 Apr 2013
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care Partners in Cancer Prevention and Care Among Aged
- ClinicalTrials.gov ID
- NCT01831375
- Acronym / sponsor ID
- R01CA098966-07
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 697 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Apr 2013 (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.
This research represents a pioneering effort to design a brief, cost effective and readily transportable program that will enable disadvantaged elders to become more effective participants in their health care.
The intervention is expected to result in trained elders becoming more knowledgeable health care partners. Trained patients will be prepared for appointments and will engage their primary care physicians in active dialogue regarding cancer prevention and screening.
Based on self-advocacy, these patients are expected to receive better preventive care and report greater satisfaction with care. Program participation can subsequently contribute to general health improvements and minimize health disparities.
Detailed description
In a randomized controlled trial (RCT) with 400 older adults, the investigators will assess the efficacy of the "Speak Up" intervention (N=200) relative to an attention control group "Connect" program (N=200), aimed at enhancing social and civic engagement. Participants will now obtain resource materials that include decision aids and diary logs to bring to visits with doctors. The investigators will implement "Speak Up" and "Connect" programs in two unique study populations: 1) participants in the ongoing NCI study and 2) older adults attending senior center programs sponsored by Area Agencies on Aging (AAAs). Participants will be assessed prior to the intervention and 2 month, and 12 months post intervention. The investigators will have an observation window of 12 months to determine whether and when the older adult obtained screening. The selection of a shorter follow-up time frame will help reduce attrition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speak Up | Experimental | Behavioral: Speak UpParticipants will learn how to speak up to their medical doctors for improving their medical care. |
| Get Connected | Other | Behavioral: Get connectedAttention control group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men and women
- Over the age of 65 from Area Agencies of Aging who are interested in participating
Key exclusion criteria (1 listed)
- No exclusion
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 |
|---|---|---|
| Speak UpAlso: The Involved Elders ProjectIntervention group_treatment group | Behavioural | Speak Up |
| Get connectedParticipants will learn to be connected with social resources in the community. | Behavioural | Get Connected |
Primary outcome
Perception of Physician Quality Scale
Time frame: one year
Perception of Physician Quality Scale(Lee \& Kasper, 1998) will be used to measure patient satisfaction with physician care (p. 21). Questions include satisfaction with physician visits and satisfaction with physician knowledge of respondent's medical problems. This scale has been utilized with elderly populations (e.g. Burton et al. 2002) and has been found to be a valid and reliable (Cronbach's alpha greater than .8) measure of patient satisfaction (Lee \& Kasper, 1998).
1 secondary outcome
Cancer Screening Recommendations
Time frame: one year
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 2 Feb 2017.
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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.
Eva Kahana, Ph.D. principal investigator
Case Western Reserve 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 Speak Up and Get connected in people with Cancer, run by Case Western Reserve 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 2 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 2 Feb 2017. 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?
Perception of Physician Quality Scale (time frame: one year). 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 2 Feb 2017.