CancerNCT01709344
Reducing Disability in Older Adult Cancer Survivors
A study testing PS-OT in people with Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Older adults who are treated for cancer are at risk of developing disabilities due to the symptoms of cancer and the side effects of treatment. Disability occurs when a person has trouble performing the activities he or she needs to do in everyday life. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PS-OT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 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
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older.
- Experiencing disability as indicated by a score of > 3 on the Vulnerable Elders Survey or an answer of "yes" to the question "Do health problems interfere with your ability to carry out your social or day to day activities?"
- Either: a. Diagnosed with any solid or hematological cancer, undergoing treatment for curative intent or within six months of completion of therapy with absence of disease recurrence; or b.Diagnosed with metastatic breast cancer or chronic hematologic malignancies with a life expectancy of > 2 years
Who cannot join
- Moderate or worse cognitive impairment as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool.
- Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder), active suicidal ideation, or active substance use disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Phase I Randomized Controlled Trial of a Problem-solving Occupational Therapy Intervention for Older Adult Cancer Survivors
Older adults who are treated for cancer are at risk of developing disabilities due to the symptoms of cancer and the side effects of treatment. Disability occurs when a person has trouble performing the activities he or she needs to do in everyday life. For example, fatigue and pain can make it difficult for an older adult to do housework, leisure, or volunteer activities. Disability makes it harder for older adults to stay active and be productive members of the community, and it can increase the costs of healthcare.
Current approaches to cancer rehabilitation focus on using exercise, education, and social support to reduce cancer treatment side effects. These are important strategies to reduce disability, yet some side effects persist despite best efforts to resolve them. To fully reduce disability, people often need to adapt their activities or the environments in which they are performed.
The goal of this study is to test an occupational therapy (OT) intervention that teaches activity planning skills to foster survivors' ability to adapt activities, routines, and environments in order to minimize disability. The project targets adults over the age of 65 who are experiencing disability during or after cancer treatment. The project has two stages. First, twelve older adult cancer survivors will individually participate in the community-based intervention. After they have completed the program the investigators will revise the intervention to emphasize what they found most effective and helpful, and to eliminate aspects of the intervention that are perceived as unhelpful or redundant. The research question for this first stage of the project is, "To what degree is it feasible for survivors to enroll in the study, complete the six-week intervention, and complete the three outcome assessments?" In the second stage of the project, the investigators will test the revised intervention, comparing it to conventional care. The research question for the second stage of the project is, "Do the people receiving the intervention have higher activity levels, greater behavioral activation, lower levels of disability, and better quality of life compared to those people who receive traditional cancer care?" The intervention is appropriate for people who have been diagnosed with any type of cancer. It is designed to focus on whatever activities are most important to each participant. The novelty of the proposed intervention lies in the combination of the OT strategies of activity and environmental adaptation with explicit training in activity planning to teach survivors to find creative ways to engage in valued activities (e.g., taking care of one's home and family members, and participating in leisure, community, social and work activities). If the intervention is effective in reducing disability, it will give us another tool to reduce the impact of cancer on the daily lives of cancer survivors.
- Conditions
- Cancer
- Being tested
- PS-OT, Usual care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS-OTBehavioural
Also called Problem-solving Occupational Therapy
Usual careOther
Supportive and rehabilitation services available at DHMC
| Study group | Role | What they receive |
|---|---|---|
| PS-OT | Experimental | Problem-solving Occupational Therapy Receives: Behavioral: PS-OT |
| Usual care | Other | Access to all supportive and rehabilitative services available at DHMC Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Late-Life Function and Disability Instrument
Measured: Eight weeks
Secondary outcomes (3)
Quality of Life
Functional Assessment of Cancer Therapy
Measured: Eight weeks
Activity level
Activity Card Sort
Measured: Eight weeks
Behavioral activation
Behavioral activation scale
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionJun 2016
- Study completionJun 2016
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.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Kathleen Lyons, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709344
- Sponsor's protocol ID
- D12110
- Status last verified
- Mar 2018
- First submitted
- 16 Oct 2012
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lyons KD, Newman R, Adachi-Mejia AM, Whipple J, Hegel MT. Content Analysis of a Participant-Directed Intervention to Optimize Activity Engagement of Older Adult Cancer Survivors. OTJR (Thorofare N J). 2018 Jan;38(1):38-45. doi: 10.1177/1539449217730356. Epub 2017 Sep 20.
PubMed 28929925
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized Controlled Trial of a Problem-solving Occupational Therapy Intervention for Older Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT01709344
- Acronym / sponsor ID
- D12110
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Feb 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Oct 2012 (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.
Older adults who are treated for cancer are at risk of developing disabilities due to the symptoms of cancer and the side effects of treatment. Disability occurs when a person has trouble performing the activities he or she needs to do in everyday life. For example, fatigue and pain can make it difficult for an older adult to do housework, leisure, or volunteer activities. Disability makes it harder for older adults to stay active and be productive members of the community, and it can increase the costs of healthcare.
Current approaches to cancer rehabilitation focus on using exercise, education, and social support to reduce cancer treatment side effects. These are important strategies to reduce disability, yet some side effects persist despite best efforts to resolve them. To fully reduce disability, people often need to adapt their activities or the environments in which they are performed.
The goal of this study is to test an occupational therapy (OT) intervention that teaches activity planning skills to foster survivors' ability to adapt activities, routines, and environments in order to minimize disability. The project targets adults over the age of 65 who are experiencing disability during or after cancer treatment. The project has two stages. First, twelve older adult cancer survivors will individually participate in the community-based intervention. After they have completed the program the investigators will revise the intervention to emphasize what they found most effective and helpful, and to eliminate aspects of the intervention that are perceived as unhelpful or redundant. The research question for this first stage of the project is, "To what degree is it feasible for survivors to enroll in the study, complete the six-week intervention, and complete the three outcome assessments?" In the second stage of the project, the investigators will test the revised intervention, comparing it to conventional care. The research question for the second stage of the project is, "Do the people receiving the intervention have higher activity levels, greater behavioral activation, lower levels of disability, and better quality of life compared to those people who receive traditional cancer care?" The intervention is appropriate for people who have been diagnosed with any type of cancer. It is designed to focus on whatever activities are most important to each participant. The novelty of the proposed intervention lies in the combination of the OT strategies of activity and environmental adaptation with explicit training in activity planning to teach survivors to find creative ways to engage in valued activities (e.g., taking care of one's home and family members, and participating in leisure, community, social and work activities). If the intervention is effective in reducing disability, it will give us another tool to reduce the impact of cancer on the daily lives of cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS-OT | Experimental | Behavioral: PS-OTProblem-solving Occupational Therapy |
| Usual care | Other | Other: Usual careAccess to all supportive and rehabilitative services available at DHMC |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65 years or older.
- Experiencing disability as indicated by a score of > 3 on the Vulnerable Elders Survey or an answer of "yes" to the question "Do health problems interfere with your ability to carry out your social or day to day activities?"
- Either: a. Diagnosed with any solid or hematological cancer, undergoing treatment for curative intent or within six months of completion of therapy with absence of disease recurrence; or b.Diagnosed with metastatic breast cancer or chronic hematologic malignancies with a life expectancy of > 2 years
Key exclusion criteria (2 listed)
- Moderate or worse cognitive impairment as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool.
- Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder), active suicidal ideation, or active substance use disorder.
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 |
|---|---|---|
| PS-OTAlso: Problem-solving Occupational Therapy | Behavioural | PS-OT |
| Usual careSupportive and rehabilitation services available at DHMC | Other | Usual care |
Primary outcome
Disability
Time frame: Eight weeks
Late-Life Function and Disability Instrument
3 secondary outcomes
Quality of Life
Time frame: Eight weeks
Activity level
Time frame: Eight weeks
Behavioral activation
Time frame: Eight weeks
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 20 Mar 2018.
- Derived from this study: PubMed 28929925Lyons KD, Newman R, Adachi-Mejia AM, Whipple J, Hegel MT. Content Analysis of a Participant-Directed Intervention to Optimize Activity Engagement of Older Adult Cancer Survivors. OTJR (Thorofare N J). 2018 Jan;38(1):38-45. doi: 10.1177/1539449217730356. Epub 2017 Sep 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS-OT in people with Cancer, run by Dartmouth-Hitchcock Medical Center 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 2 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 20 Mar 2018. 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?
Disability (time frame: Eight weeks). 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 NCT01709344, 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 20 Mar 2018.