Reducing Disability in Older Adult Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Kathleen Lyons, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01709344
First received: October 16, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Cancer
Behavioral: PS-OT
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Phase I Randomized Controlled Trial of a Problem-solving Occupational Therapy Intervention for Older Adult Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Disability [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Late-Life Function and Disability Instrument


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Functional Assessment of Cancer Therapy

  • Activity level [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Activity Card Sort

  • Behavioral activation [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Behavioral activation scale


Other Outcome Measures:
  • Depression [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Patient Health Questionnaire-9 (PHQ-9)


Estimated Enrollment: 72
Study Start Date: February 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PS-OT
Problem-solving Occupational Therapy
Behavioral: PS-OT
Other Name: Problem-solving Occupational Therapy
Usual care
Access to all supportive and rehabilitative services available at DHMC
Other: Usual care
Supportive and rehabilitation services available at DHMC

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Age 65 years or older.
  2. 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?"
  3. 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

Exclusion Criteria

  1. Moderate or worse cognitive impairment as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool.
  2. Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder), active suicidal ideation, or active substance use disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709344

Contacts
Contact: Ingrid A Svensborn, RN 603-653-9128 Ingrid.A.Svensborn@hitchcock.org

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Ingrid A Svensborn    603-653-9128    Ingrid.A.Svensborn@hitchcock.org   
Principal Investigator: Kathleen D Lyons, ScD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
American Cancer Society, Inc.
  More Information

No publications provided

Responsible Party: Kathleen Lyons, Research Assistant Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01709344     History of Changes
Other Study ID Numbers: D12110
Study First Received: October 16, 2012
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

ClinicalTrials.gov processed this record on September 18, 2014