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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT01709344
Study groupRoleWhat they receive
PS-OTExperimentalProblem-solving Occupational Therapy
Receives: Behavioral: PS-OT
Usual careOtherAccess 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.

  1. Disability

    Late-Life Function and Disability Instrument

    Measured: Eight weeks

Secondary outcomes (3)
  1. Quality of Life

    Functional Assessment of Cancer Therapy

    Measured: Eight weeks

  2. Activity level

    Activity Card Sort

    Measured: Eight weeks

  3. 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.

  1. First posted18 Oct 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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)
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

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.

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